Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Head of Bed Elevation in Symptoms of Patients With Gastroesophageal Reflux Disease (IBELGA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02706938
Recruitment Status : Completed
First Posted : March 11, 2016
Results First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Universidad Nacional de Colombia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Gastroesophageal Reflux Disease
Interventions Other: Head of bed elevation
Other: Standard treatment
Enrollment 65
Recruitment Details This trial was conducted at the outpatient visit of the Gastroenterology, Digestive endoscopy and Liver Diseases Unit in Clínica Fundadores, Bogotá, Colombia. A search for eligible patients was also conducted by using a Local Endoscopy Database with a time frame from 2014 to 2016, and patients with esophagitis were contacted by telephone.
Pre-assignment Details 1082 out of 1147 potentially eligible patients were excluded prior to randomization. 941 patients did not meet the inclusion criteria and 105 patients had at least one exclusion criteria. 36 patients declined their participation before starting the clinical trial.
Arm/Group Title Head of Bed Elevation - Control Control - Head of Bed Elevation
Hide Arm/Group Description

Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks. After a washout 2 week period, participants will sleep in a bed without inclination for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed

Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Participants will sleep in a bed without inclination during a first period of 6 weeks. After a washout 2 week period, participants will sleep with head of bed raised with standard 20 cm-height wooden blocks for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed

Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Period Title: First Period, 6 Weeks
Started 32 33
Completed 21 31
Not Completed 11 2
Reason Not Completed
Adverse Event             8             0
Lost to Follow-up             2             2
Withdrawal by Subject             1             0
Period Title: Second Period, 6 Weeks
Started 21 31
Completed [1] 21 [2] 21 [3]
Not Completed 0 10
Reason Not Completed
Adverse Event             0             7
Withdrawal by Subject             0             3
[1]
Because this is a crossover trial, only 39 patients who completed both interventions were analyzed.
[2]
Only data from 20 patients were finally analyzed because of missing data.
[3]
Only data from 19 patients were finally analyzed because of missing data.
Arm/Group Title Head of Bed Elevation - Control Control - Head of Bed Elevation Total
Hide Arm/Group Description

Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks. After a washout 2 week period, participants will sleep in a bed without inclination for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed

Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Participants will sleep in a bed without inclination during a first period of 6 weeks. After a washout 2 week period, participants will sleep with head of bed raised with standard 20 cm-height wooden blocks for a second period of 6 weeks. During the trial, every patient will receive standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed

Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Total of all reporting groups
Overall Number of Baseline Participants 32 33 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Year
Number Analyzed 32 participants 33 participants 65 participants
57  (8.0) 54  (12.6) 55.5  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
Female
23
  71.9%
30
  90.9%
53
  81.5%
Male
9
  28.1%
3
   9.1%
12
  18.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   3.0%
1
   1.5%
White
32
 100.0%
32
  97.0%
64
  98.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Los Angeles Classification   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
Grade A Esophagitis
23
  71.9%
30
  90.9%
53
  81.5%
Grade B Esophagitis
8
  25.0%
3
   9.1%
11
  16.9%
Grade C Esophagitis
0
   0.0%
0
   0.0%
0
   0.0%
Grade D Esophagitis
1
   3.1%
0
   0.0%
1
   1.5%
[1]
Measure Description: Participants were graded according to the extension of endoscopically confirmed mucosal breaks in the esophagus. Letters from A to D were used for grading, with A meaning a smaller mucosal tear, and D meaning a bigger mucosal tear.
GERD diagnosis   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 32 participants 33 participants 65 participants
5
(3 to 10)
5
(2 to 10)
5
(2 to 10)
[1]
Measure Description: Self reported years since gastroesophageal reflux disease diagnosis
GERD-associated sleep disturbance  
Median (Inter-Quartile Range)
Unit of measure:  Nights per week
Number Analyzed 32 participants 33 participants 65 participants
3.5
(3 to 5)
4
(3 to 4)
4
(3 to 5)
Proton pump inhibitor use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
25
  78.1%
31
  93.9%
56
  86.2%
Omeprazole use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
4
  12.5%
6
  18.2%
10
  15.4%
Esomeprazole use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
15
  46.9%
22
  66.7%
37
  56.9%
Lansoprazole use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
6
  18.8%
3
   9.1%
9
  13.8%
Sodium Alginate use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
7
  21.9%
6
  18.2%
13
  20.0%
GERD therapy adherence   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 30 participants 56 participants
14
  53.8%
18
  60.0%
32
  57.1%
[1]
Measure Description: The values in the table refer to those participants who were considered having "adherence" to their therapy by means of Morinsky-Green-Levine test.
[2]
Measure Analysis Population Description: Row population differs from the Overall because of missing data
OTC antacid use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
4
  12.5%
6
  18.2%
10
  15.4%
[1]
Measure Description: Over-the-counter antacid use
Number of pillows  
Median (Inter-Quartile Range)
Unit of measure:  Pillows
Number Analyzed 32 participants 33 participants 65 participants
2
(1 to 2)
2
(1 to 2)
2
(1 to 2)
Sleep medication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
5
  15.6%
5
  15.2%
10
  15.4%
Nocturia   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Nights per week
Number Analyzed 32 participants 33 participants 65 participants
3.5
(0.5 to 7)
6
(1 to 7)
4
(1 to 7)
[1]
Measure Description: The need to wake at night one or more times for voiding
Cups of coffee   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Cup
Number Analyzed 32 participants 33 participants 65 participants
1
(0 to 2)
1
(0 to 2)
1
(0 to 2)
[1]
Measure Description: Patients reported the number of cups of coffee they usually drink daily, taking into account a standard cup of 195 mL.
Weight   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 31 participants 33 participants 64 participants
67.5  (12.7) 61.8  (9.5) 64.6  (11.4)
[1]
Measure Description: Self-reported weight
[2]
Measure Analysis Population Description: This row populattion differs from the overall because of missed data
Height   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 31 participants 33 participants 64 participants
161.4  (9.6) 159.4  (5.7) 160.4  (7.8)
[1]
Measure Description: Self-reported height
[2]
Measure Analysis Population Description: This row populattion differs from the overall because of missed data
Body Mass Index   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Kilogram/square meter
Number Analyzed 31 participants 33 participants 64 participants
24.5
(22.9 to 27.8)
24.9
(22.7 to 25.9)
24.6
(22.8 to 26.8)
[1]
Measure Analysis Population Description: This row populattion differs from the overall because of missed data
Basal RDQ score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 31 participants 32 participants 63 participants
3.8  (1.01) 4  (1.08) 3.9  (1.04)
[1]
Measure Description: Participants were graded according to presence and intensity of reflux symptoms. Reflux Disease Questionnaire (RDQ) was used as a scale with a range from 0 to 6 points, being 0 abscence of symptoms, and 6 the worst intensity of reflux symptoms.
[2]
Measure Analysis Population Description: This row populattion differs from the overall because of missed data
SF-36 score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants 31 participants 61 participants
54  (19.9) 48.8  (21.4) 51.3  (20.7)
[1]
Measure Description: Participants were graded according to a measure of their overall quality of life. Short Form 36 (SF-36) was used as a scale with a range from 0 to 100 percent, being 0 the worst quality of life, and 100 the best quality of life.
[2]
Measure Analysis Population Description: This row populattion differs from the overall because of missed data
SF-36 Physical Function domain   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants 31 participants 61 participants
65
(45 to 80)
55
(35 to 80)
60
(35 to 80)
[1]
Measure Description: Participants were graded according to a measure of their quality of life, having into account their physical performance. Short Form 36 Physical Function Domain, a sub-scale of SF-36 was used with a range from 0 to 100 percent, being 0 the worst quality of life, and 100 the best quality of life.
[2]
Measure Analysis Population Description: This row populattion differs from the overall because of missed data
SF-36 Physical Role domain   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants 31 participants 61 participants
49.2  (45.7) 32.2  (42.4) 40.6  (44.5)
[1]
Measure Description: Participants were graded according to a measure of their quality of life, having into account if they had role limitations due to physical problems. Short Form 36 Physical Role Domain, a sub-scale of SF-36 was used with a range from 0 to 100 percent, being 0 the worst quality of life, and 100 the best quality of life.
[2]
Measure Analysis Population Description: This row populattion differs from the overall because of missed data
SF-36 Bodily Pain domain   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants 31 participants 61 participants
43.8  (25) 40.9  (26.5) 42.3  (25.6)
[1]
Measure Description: Participants were graded according to a measure of their quality of life, having into account their bodily pain. Short Form 36 Bodily Pain Domain, a sub-scale of SF-36 was used with a range from 0 to 100 percent, being 0 the worst quality of life, and 100 the best quality of life.
[2]
Measure Analysis Population Description: This row populattion differs from the overall because of missed data
SF-36 General Health Domain   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants 31 participants 61 participants
51.8  (16.5) 49.5  (18.2) 50.6  (17.3)
[1]
Measure Description: Participants were graded according to a measure of their quality of life, having into account their general health. Short Form 36 General Health Domain, a sub-scale of SF-36 was used with a range from 0 to 100 percent, being 0 the worst quality of life, and 100 the best quality of life.
[2]
Measure Analysis Population Description: Row population differs from the Overall because of missing data
SF-36 Vitality Domain   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants 31 participants 61 participants
51  (15.8) 45.5  (20.7) 48.2  (18.5)
[1]
Measure Description: Participants were graded according to a measure of their quality of life, having into account their vitality. Short Form 36 Vitality Domain, a sub-scale of SF-36 was used with a range from 0 to 100 percent, being 0 the worst quality of life, and 100 the best quality of life.
[2]
Measure Analysis Population Description: Row population differs from the Overall because of missing data
SF-36 Social Function Domain   [1] [2] 
Median (Inter-Quartile Range)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants 31 participants 61 participants
67.5
(55 to 90)
67.5
(42.5 to 87.5)
67.5
(55 to 87.5)
[1]
Measure Description: Participants were graded according to a measure of their quality of life, having into account their social performance. Short Form 36 Social Function Domain, a sub-scale of SF-36 was used with a range from 0 to 100 percent, being 0 the worst quality of life, and 100 the best quality of life.
[2]
Measure Analysis Population Description: Row population differs from the Overall because of missing data
SF-36 Emotional Role domain   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants 31 participants 61 participants
60  (44.1) 57  (45.7) 58.5  (44.6)
[1]
Measure Description: Participants were graded according to a measure of their quality of life, having into account if they had role limitations due to emotional problems. Short Form 36 Emotional Role Domain, a sub-scale of SF-36 was used with a range from 0 to 100 percent, being 0 the worst quality of life, and 100 the best quality of life.
[2]
Measure Analysis Population Description: Row population differs from the Overall because of missing data
SF-36 Mental Health domain   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants 31 participants 61 participants
60.8  (18) 57.9  (22.8) 59.3  (20.5)
[1]
Measure Description: Participants were graded according to a measure of their quality of life, having into account their mental health. Short Form 36 Mental Health Domain, a sub-scale of SF-36 was used with a range from 0 to 100 percent, being 0 the worst quality of life, and 100 the best quality of life.
[2]
Measure Analysis Population Description: Row population differs from the Overall because of missing data
SF-36 Transition domain   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 30 participants 31 participants 61 participants
45  (19) 37.9  (22.2) 41.4  (20.8)
[1]
Measure Description: Participants were graded according to a measure of their quality of life, having into account if they felt a transition of their general health during the previous year. Short Form 36 Transition Domain, a sub-scale of SF-36 was used with a range from 0 to 100 percent. Lower percent values mean that participant believes general health is much worse now than one year ago, and higher percent values mean that participant believes general health is much better now than one year ago.
[2]
Measure Analysis Population Description: Row population differs from the Overall because of missing data
Comorbidities   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Comorbidity
Number Analyzed 32 participants 33 participants 65 participants
1.5
(1 to 2)
2
(1 to 3)
2
(1 to 3)
[1]
Measure Description: Number of other chronic illnesses
Arterial hypertension   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
6
  18.8%
5
  15.2%
11
  16.9%
[1]
Measure Description: Previous diagnosis of chronic arterial hypertension
Varicose veins   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
3
   9.4%
8
  24.2%
11
  16.9%
[1]
Measure Description: Previous diagnosis of varicose veins in the legs
Hypothyroidism   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
4
  12.5%
6
  18.2%
10
  15.4%
[1]
Measure Description: Previous diagnosis of hypothyroidism
Fibromyalgia   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
5
  15.6%
5
  15.2%
10
  15.4%
[1]
Measure Description: Previous diagnosis of fibromyalgia
Arthrosis   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
5
  15.6%
4
  12.1%
9
  13.8%
[1]
Measure Description: Previous diagnosis of arthrosis
Irritable bowel syndrome   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
3
   9.4%
5
  15.2%
8
  12.3%
[1]
Measure Description: Previous diagnosis of irritable bowel syndrome
Depressive disorder   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
2
   6.3%
6
  18.2%
8
  12.3%
[1]
Measure Description: Previous diagnosis of depressive disorder
Obesity   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 33 participants 64 participants
6
  19.4%
2
   6.1%
8
  12.5%
[1]
Measure Description: Participants with a body mass index of 30 or greater
[2]
Measure Analysis Population Description: Row population differs from the Overall because of missing data
Anxiety disorder   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
3
   9.4%
4
  12.1%
7
  10.8%
[1]
Measure Description: Previous diagnosis of anxiety disorder
Spondylopathy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
2
   6.3%
2
   6.1%
4
   6.2%
[1]
Measure Description: Previous diagnosis of any spondylopathy
Type 2 Diabetes Mellitus   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
1
   3.1%
2
   6.1%
3
   4.6%
[1]
Measure Description: Previous diagnosis of type 2 diabetes mellitus
Other comorbidities   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 33 participants 65 participants
10
  31.3%
16
  48.5%
26
  40.0%
[1]
Measure Description: Previous diagnosis of any other comorbidities
1.Primary Outcome
Title Change in Reflux Disease Questionnaire Scores Administered at Baseline and 6 Weeks After Each Intervention
Hide Description Change in Reflux Disease Questionnaire Scores administered at baseline and 6 weeks after each intervention. Range from 0 to 6, with a higher punctuation meaning a worse outcome. Symptom change of ≥ 0,6 points from baseline was considered clinically relevant.
Time Frame Primary outcome will be assessed at baseline and 6 weeks after starting each period
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received the intervention head of bed elevation were grouped, regardless of the arm of the study they came from. Likewise, all participants of any arm who received control intervention were grouped. Only 39 patients who completed both interventions were analyzed because of the crossover nature of this clinical trial.
Arm/Group Title Head of Bed Elevation Control
Hide Arm/Group Description:

Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks.

Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed

Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Participants will sleep in a bed without inclination during a first period of 6 weeks.

Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.2397  (1.2236) 0.0869  (1.2562)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Head of Bed Elevation, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments One tail paired t test.
Statistical Test of Hypothesis P-Value 0.0002
Comments A priori threshold for statistical significance was 0.05
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.3267
Confidence Interval (2-Sided) 95%
0.6263 to 2.0270
Parameter Dispersion
Type: Standard Deviation
Value: 2.1604
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Head of Bed Elevation, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments McNemar's chi squared statistic
Statistical Test of Hypothesis P-Value 0.0082
Comments A priori threshold for statistical significance was 0.05
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.3590
Confidence Interval (2-Sided) 95%
-0.6255 to -0.0924
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Quality of Life as Assessed by Short Form 36 Questionnaire, Administered at Baseline and 6 Weeks After Each Intervention
Hide Description Change in Short Form 36 Scores administered at baseline and 6 weeks after each intervention. Range from 0 to 100, with a higher punctuation meaning a better outcome. Quality of life change of ≥ 10 points from baseline was considered clinically relevant.
Time Frame Secondary outcome will be assessed at baseline and 6 weeks after starting each period
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received the intervention head of bed elevation were grouped, regardless of the arm of the study they came from. Likewise, all participants of any arm who received control intervention were grouped. For crossover reasons, only 39 patients who completed both interventions were analyzed, and 1 patient was excluded because of missing data
Arm/Group Title Head of Bed Elevation Control
Hide Arm/Group Description:

Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks.

Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed

Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Participants will sleep in a bed without inclination during a first period of 6 weeks.

Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Overall Number of Participants Analyzed 38 38
Mean (Standard Deviation)
Unit of Measure: scores on a scale
6.5992  (19.0268) -0.3139  (17.6856)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Head of Bed Elevation, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments One tail paired t test.
Statistical Test of Hypothesis P-Value 0.099
Comments A priori threshold for statistical significance was 0.05
Method t-test, 1 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.9131
Confidence Interval (2-Sided) 95%
-17.5987 to 3.7724
Parameter Dispersion
Type: Standard Deviation
Value: 32.5093
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Head of Bed Elevation, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments McNemar's chi squared statistic
Statistical Test of Hypothesis P-Value 0.8084
Comments A priori threshold for statistical significance was 0.05
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0263
Confidence Interval (2-Sided) 95%
-0.2651 to 0.2125
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Patient Preference
Hide Description Percentage of patients who preferred head of bed elevation after trial ending
Time Frame Secondary outcome will be assessed 14 weeks after starting the trial
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who used both head of bed elevation and control interventions, regardless they did not complete the entire trial or did not retrieve all the questionnaires, were asked for their preference between head of bed elevation or control intervention.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants who used both head of bed elevation and control interventions, regardless they did not complete the entire trial or did not retrieve all the questionnaires.
Overall Number of Participants Analyzed 57
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
63.158
(50.635 to 75.681)
Time Frame Adverse event data were collected over a period of 14 weeks for each participant.
Adverse Event Reporting Description

The definition of serious adverse event differs from the clinicaltrials.gov definition. In the present study a serious adverse event was the one that led the patient to the suspension of the therapeutic intervention.

Adverse event information were collected during six serial and telephonic interviews for each patient enrolled in the study.

 
Arm/Group Title Head of Bed Elevation Control
Hide Arm/Group Description

Participants will sleep with head of bed raised with standard 20 cm-height wooden blocks during a first period of 6 weeks.

Head of bed elevation: Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed

Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

Participants will sleep in a bed without inclination during a first period of 6 weeks.

Standard treatment: Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.

All-Cause Mortality
Head of Bed Elevation Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)      0/54 (0.00%)    
Hide Serious Adverse Events
Head of Bed Elevation Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/63 (23.81%)      0/54 (0.00%)    
Musculoskeletal and connective tissue disorders     
Cervical pain * 3  2/63 (3.17%)  2 0/54 (0.00%)  0
Lumbar pain * 4  2/63 (3.17%)  2 0/54 (0.00%)  0
Product Issues     
Bed slipping * 2 [1]  4/63 (6.35%)  4 0/54 (0.00%)  0
Bed unsteadiness * 5 [2]  3/63 (4.76%)  3 0/54 (0.00%)  0
Vascular disorders     
Varicose veins pain * 1 [3]  4/63 (6.35%)  4 0/54 (0.00%)  0
1
Term from vocabulary, Varicose veins pain
2
Term from vocabulary, Bed slipping
3
Term from vocabulary, Cervical pain
4
Term from vocabulary, Lumbar pain
5
Term from vocabulary, Bed unsteadiness
*
Indicates events were collected by non-systematic assessment
[1]
Participants reported they slip themselves from the surface of the bed, because of bed inclination.
[2]
Patients reported their bed was unstable when using wooden blocks for head of bed elevation
[3]
Lower limbs pain attributed to local venous insufficiency
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Head of Bed Elevation Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/63 (38.10%)      0/54 (0.00%)    
Musculoskeletal and connective tissue disorders     
Cervical pain * 4  1/63 (1.59%)  1 0/54 (0.00%)  0
Lumbar pain * 5  1/63 (1.59%)  1 0/54 (0.00%)  0
Knee pain * 6  1/63 (1.59%)  1 0/54 (0.00%)  0
Nervous system disorders     
Headache * 3  1/63 (1.59%)  1 0/54 (0.00%)  0
Product Issues     
Bed slipping * 1 [1]  16/63 (25.40%)  16 0/54 (0.00%)  0
Bed unsteadiness * 7  1/63 (1.59%)  1 0/54 (0.00%)  0
Reproductive system and breast disorders     
Sexual activity interference * 8 [2]  1/63 (1.59%)  1 0/54 (0.00%)  0
Vascular disorders     
Varicose veins pain * 2 [3]  6/63 (9.52%)  6 0/54 (0.00%)  0
1
Term from vocabulary, Bed slipping
2
Term from vocabulary, Varicose veins pain
3
Term from vocabulary, Headache
4
Term from vocabulary, Cervical pain
5
Term from vocabulary, Lumbar pain
6
Term from vocabulary, Knee pain
7
Term from vocabulary, Bed unsteadiness
8
Term from vocabulary, Sexual activity inte
*
Indicates events were collected by non-systematic assessment
[1]
Participants reported they slip themselves from the surface of the bed, because of bed inclination.
[2]
Patients reported their sexual activity was difficult when using wooden blocks for head of bed elevation
[3]
Lower limbs pain attributed to local venous insufficiency
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ivan Mauricio Villamil Morales
Organization: Universidad Nacional de Colombia
Phone: +573178755369
EMail: imvillamilm@unal.edu.co
Publications:
Gastroenterological Society of Australia (GESA). Reflux disease: Gastrooesophageal reflux disease in adults. Victoria: GESA 2011. Available from: http://www.gesa.org.au/files/editor_upload/File/Professional/Reflux_Disease.pdf (Accessed Dic, 2014).
Layout table for additonal information
Responsible Party: Universidad Nacional de Colombia
ClinicalTrials.gov Identifier: NCT02706938    
Other Study ID Numbers: IBELGA
First Submitted: March 8, 2016
First Posted: March 11, 2016
Results First Submitted: November 14, 2018
Results First Posted: June 24, 2019
Last Update Posted: June 24, 2019