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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

Brief Summary:

BACKGROUND: Gastroesophageal reflux disease is a very frequent clinical condition and nocturnal symptoms are a cause of quality of life impairment, poor sleep quality and absenteeism. Head of bed elevation, as a low-cost non pharmacologic anti-reflux treatment is nowadays recommended, but its clinical impact in patients with nocturnal symptoms remains unknown due to inconsistent results and methodological limitations among different clinical trials, most of which were performed before the widespread use of proton pump inhibitors in clinical practice.

HYPOTHESIS: Head of bed elevation is a useful treatment for patients with gastroesophageal reflux disease and nocturnal symptoms, and has a positive impact in quality of life in these patients.

STUDY OBJECTIVE: To assess the effectiveness of head of bed elevation for treatment of patients with gastroesophageal reflux disease and nocturnal symptoms, and to determine the impact of this intervention in quality of life of these patients.

METHODS: Randomized single-blind single-centre controlled clinical trial with a 2x2 cross-over design. A sample of 42 patients attending to the outpatient gastroenterology unit at Clínica Fundadores in Bogotá city, who met the inclusion criteria and had no exclusion criteria were selected to participate. Included patients were randomized to raise the head of bed with standard 20 cm-height wooden blocks or to sleep without bed inclination during the first 6 week period. After a 2 week washout period, allocation was crossed and participants were followed again during a second 6 week period. During the trial, every patient received standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate. After allocation concealment, the researchers in charge of statistical analysis and reporting results were blinded for the non pharmacological intervention under study. Primary outcome was a significant symptom change according to Reflux Disease Questionnaire (RDQ) validated form. Secondary outcomes include impact on quality of life according to Short Form 36 (SF-36) validated questionnaire, patient preference and adverse events of non-pharmacological intervention. Statistical analysis was carried out with STATA 13.0 (Special Edition) for Windows. Differences with a p<0,05 were accepted as statistically significant.


Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Other: Head of bed elevation Other: Standard treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized single-blind single-centre controlled clinical trial with a 2x2 cross-over design.
Masking: Single (Outcomes Assessor)
Masking Description: Because HBE is not susceptible to double-blinding, patients allocated to the intervention group will always be aware of the group they belong to. However, the researcher in charge of statistical analysis of data and writing the results report will work with random-generated alphabetical group codes for masking the intervention in each one of the periods of the trial.
Primary Purpose: Treatment
Official Title: Impact of Head of Bed Elevation in Symptoms of Patients With Gastroesophageal Reflux Disease: a Randomized Single-blind Study
Actual Study Start Date : April 8, 2016
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : November 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Head of bed elevation - Control
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.
Other: 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

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

Control - Head of bed elevation
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.
Other: 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

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




Primary Outcome Measures :
  1. Change in Reflux Disease Questionnaire Scores Administered at Baseline and 6 Weeks After Each Intervention [ Time Frame: Primary outcome will be assessed at baseline and 6 weeks after starting each period ]
    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.


Secondary Outcome Measures :
  1. Change in Quality of Life as Assessed by Short Form 36 Questionnaire, Administered at Baseline and 6 Weeks After Each Intervention [ Time Frame: Secondary outcome will be assessed at baseline and 6 weeks after starting each period ]
    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.

  2. Patient Preference [ Time Frame: Secondary outcome will be assessed 14 weeks after starting the trial ]
    Percentage of patients who preferred head of bed elevation after trial ending



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Esophageal erosions
  • Retrosternal pyrosis lasting ≥ 3 months
  • Pyrosis and/or regurgitation with a frequency ≥ 3 nights per week
  • GERD-associated sleep disturbance (insomnia, poor sleep quality) lasting ≥ 1 month
  • GERD-associated sleep disturbance (insomnia, poor sleep quality) with a frequency ≥ 3 nights per week

Exclusion Criteria:

  • Non-erosive gastroesophageal reflux disease (NERD)
  • Peptic ulcer
  • History of upper gastrointestinal surgery (except for cholecystectomy)
  • Lactating or pregnant women
  • Nighttime shift workers (12 am to 6 am)
  • Obstructive sleep apnea hypopnea syndrome
  • Chronic obstructive pulmonary disease
  • Patients with nocturnal supplementary oxygen requirement
  • Orthopnea
  • Restless legs syndrome
  • Patients consuming more than 3 cups of coffee per day
  • Patients planning to travel beyond 3 time zones during study
  • Patients being treated with sleep medication (e.g. anxiolytics, antihistamines, benzodiazepines) for less than 3 months
  • Patients being treated with sleep medication (e.g. anxiolytics, antihistamines, benzodiazepines), when suspension or dose modification of this drugs is being planned during the study course

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706938


Locations
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Colombia
Clínica Fundadores
Bogotá, Cundinamarca, Colombia
Sponsors and Collaborators
Universidad Nacional de Colombia
Investigators
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Principal Investigator: Ivan M Villamil Morales, MD Universidad Nacional de Colombia
Study Director: William A Otero Regino, MD, MSc Universidad Nacional de Colombia, Clínica Fundadores
  Study Documents (Full-Text)

Documents provided by Universidad Nacional de Colombia:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: Informed Consent Form
Informed Consent Form
Basic Data Formulary  This link exits the ClinicalTrials.gov site
Identifier: Basic Data Formulary
Formulary for gathering basic variables of each participant
SF-36 questionnaire  This link exits the ClinicalTrials.gov site
Identifier: SF-36 questionnaire
Questionnaire for assessing secondary outcome
RDQ questionnaire  This link exits the ClinicalTrials.gov site
Identifier: RDQ questionnaire
Questionnaire for assessing primary outcome
Instructions for the patient  This link exits the ClinicalTrials.gov site
Identifier: Instruction for the patient
Written instructions for the patient about how to use wooden prisms.
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: Clinical Trial Protocol

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).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidad Nacional de Colombia
ClinicalTrials.gov Identifier: NCT02706938    
Other Study ID Numbers: IBELGA
First Posted: March 11, 2016    Key Record Dates
Results First Posted: June 24, 2019
Last Update Posted: June 24, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universidad Nacional de Colombia:
Gastroesophageal reflux disease
Head of bed elevation
Quality of life
Nocturnal symptoms
Lifestyle measures
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases