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A Randomized Cross Over Trial of Two Treatments for Sleep Apnea in Veterans With Post-Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT01569022
Recruitment Status : Completed
First Posted : April 2, 2012
Results First Posted : November 8, 2017
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obstructive Sleep Apnea
Interventions Device: CPAP
Device: MAD
Enrollment 42
Recruitment Details A total of 127 Veterans were considered for study participation between August 2013 and April 2016. Fifty-four patients agreed to enroll in the study but twelve patients either failed to return for scheduled visits or withdrew from further participation because of lack of time or other pressing matters. Forty-two were randomized to CPAP or MAD.
Pre-assignment Details  
Arm/Group Title CPAP First, MAD MAD First, CPAP
Hide Arm/Group Description

CPAP treatment for sleep apnea

CPAP: CPAP Treatment for 12 weeks MAD: MAD treatment for 12 weeks

MAD treatment for sleep apnea

MAD: MAD Treatment for 12 weeks CPAP: CPAP treatment for 12 weeks

Period Title: First Intervention
Started 21 21
Completed 19 20
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             1
Period Title: Second Intervention
Started 19 20
Completed 17 18
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             2             2
Arm/Group Title All Study Participants
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Participants were asked to acclimate to CPAP and MAD for 4 weeks (total) during which adjustments to both modes of therapy are made aiming to optimize comfort and abolish snoring.

If the interface was found to be uncomfortable, the patient was given the opportunity to change the mask. None of the participants was exposed to dual therapy or had access to both devices at the same time. Weekly phone calls were made to inquire about side effects or problems with CPAP or MAD. At the end of the acclimatization period, patients underwent a 2-week washout, after which they were randomly assigned in 1:1 ratio via a presealed and numbered opaque white envelope to one of the two treatment modalities (CPAP or MAD) that included the assignment to receive 12 weeks of treatment with MAD and CPAP in alternating order

Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
52.7  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
5
  14.3%
Male
30
  85.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  14.3%
White
30
  85.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Residual Apnea Hypopnea Index
Hide Description The primary endpoint of the study was tested by comparing the upper limit of the 95% confidence interval for the CPAP-MAD difference in residual AHI with the a priori noninferiority margin using the paired t test
Time Frame up to 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPAP Mandibular Advancing Device
Hide Arm/Group Description:

CPAP treatment for sleep apnea

CPAP: CPAP Treatment for 12 weeks

MAD treatment for sleep apnea

MAD: MAD Treatment for 12 weeks

Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: events per hour
3.9  (4.8) 26.3  (25.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CPAP, Mandibular Advancing Device
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The primary endpoint of the study was tested by comparing difference in residual AHI using the paired t test
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Health Outcomes
Hide Description Health outcomes including ESS, PCL-M, and PSQI. ESS is a short questionnaire validated to measure excessive daytime sleepiness in patients with OSA 17. It measures the likelihood of falling asleep in eight different situations, with a score of 0-3 for each situation. The sum of individual scores for the eight items gives the final ESS score, ranging from 0-21. An ESS score >10 suggests excessive daytime sleepiness (EDS). The PSQI is a self-rating questionnaire that consists of seven dimensions. The possible scores range from 0–21, with greater than five indicative of impaired sleep quality. The PTSD Checklist is a 17-item self-report measure (1-5 points each) that assesses PTSD symptoms in relation to stressful military experiences. PTSD symptom severity scores are determined by summing the participants’ answers to all 17 items from 1 (“not at all”) to 5 (“extremely”)(range 17-85) 14 with 5-10 point change indicating statistically significant response to treatment
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPAP Mandibular Advancing Device
Hide Arm/Group Description:
CPAP treatment for 12 weeks
Mandibular advancing device treatment for 12 weeks
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
Epworth Sleepiness Scale 9.4  (4.7) 9.5  (4.9)
PTSD Checklist 49.9  (15.4) 50.03  (13.64)
Pitt sleep quality index 17.3  (0.2) 17.3  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CPAP, Mandibular Advancing Device
Comments ESS
Type of Statistical Test Equivalence
Comments t test assuming unequal variance
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CPAP, Mandibular Advancing Device
Comments PCL
Type of Statistical Test Equivalence
Comments t test assuming unequal variance
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CPAP, Mandibular Advancing Device
Comments PSQI
Type of Statistical Test Equivalence
Comments t-test assuming non unequal variance
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title General Health SF-36
Hide Description The SF-36 is a generic 36-item Short Form Medical Outcomes Survey (SF-36) 16. It has eight main domains: physical functioning, role limitation due to physical problems, role limitation due to emotional problems, social functioning, mental health, energy/vitality, bodily pain, and general health perception. General Health SF36 score is coded, summed, and transformed onto a scale from 0 to 100 (worst to best possible health).
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPAP Mandibular Advancing Device
Hide Arm/Group Description:
CPAP treatment for 12 weeks
Mandibular advancing device treatment for 12 weeks
Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
49.33  (17.09) 50.58  (15.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CPAP, Mandibular Advancing Device
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments t test assuming unequal variance
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Adherence to Therapy
Hide Description comparison of the number of hours per night used while on CPAP versus MAD
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CPAP Mandibular Advancing Device
Hide Arm/Group Description:

CPAP treatment for sleep apnea

CPAP: CPAP Treatment for 12 weeks

MAD treatment for sleep apnea

MAD: MAD Treatment for 12 weeks

Overall Number of Participants Analyzed 35 35
Mean (Standard Deviation)
Unit of Measure: hours per night
3.4  (2.48) 5.66  (2.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CPAP, Mandibular Advancing Device
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments t test assuming unequal variance
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CPAP Mandibular Advancing Device
Hide Arm/Group Description

CPAP treatment for sleep apnea

CPAP: CPAP Treatment for 12 weeks

MAD treatment for sleep apnea

MAD: MAD Treatment for 12 weeks

All-Cause Mortality
CPAP Mandibular Advancing Device
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CPAP Mandibular Advancing Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      0/35 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CPAP Mandibular Advancing Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/35 (74.29%)      14/35 (40.00%)    
General disorders     
Dry mouth   10/35 (28.57%)  10 6/35 (17.14%)  6
Musculoskeletal and connective tissue disorders     
Jaw pain   0/35 (0.00%)  0 9/35 (25.71%)  9
Respiratory, thoracic and mediastinal disorders     
mask discomfort   15/35 (42.86%)  15 0/35 (0.00%)  0
claustrophobia   11/35 (31.43%)  11 0/35 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ali El Solh
Organization: VA Western New York
Phone: 716-862-6525
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01569022     History of Changes
Other Study ID Numbers: CLIN-005-11F
First Submitted: March 20, 2012
First Posted: April 2, 2012
Results First Submitted: August 25, 2017
Results First Posted: November 8, 2017
Last Update Posted: November 8, 2017