Trial Outcomes & Findings for A Randomized Cross Over Trial of Two Treatments for Sleep Apnea in Veterans With Post-Traumatic Stress Disorder (NCT NCT01569022)
NCT ID: NCT01569022
Last Updated: 2017-11-08
Results Overview
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
COMPLETED
NA
42 participants
up to 12 weeks
2017-11-08
Participant Flow
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.
Participant milestones
| Measure |
CPAP First, MAD
CPAP treatment for sleep apnea
CPAP: CPAP Treatment for 12 weeks MAD: MAD treatment for 12 weeks
|
MAD First, CPAP
MAD treatment for sleep apnea
MAD: MAD Treatment for 12 weeks CPAP: CPAP treatment for 12 weeks
|
|---|---|---|
|
First Intervention
STARTED
|
21
|
21
|
|
First Intervention
COMPLETED
|
19
|
20
|
|
First Intervention
NOT COMPLETED
|
2
|
1
|
|
Second Intervention
STARTED
|
19
|
20
|
|
Second Intervention
COMPLETED
|
17
|
18
|
|
Second Intervention
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
CPAP First, MAD
CPAP treatment for sleep apnea
CPAP: CPAP Treatment for 12 weeks MAD: MAD treatment for 12 weeks
|
MAD First, CPAP
MAD treatment for sleep apnea
MAD: MAD Treatment for 12 weeks CPAP: CPAP treatment for 12 weeks
|
|---|---|---|
|
First Intervention
Lost to Follow-up
|
2
|
1
|
|
Second Intervention
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
A Randomized Cross Over Trial of Two Treatments for Sleep Apnea in Veterans With Post-Traumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
All Study Participants
n=35 Participants
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
|
|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksThe 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
Outcome measures
| Measure |
CPAP
n=35 Participants
CPAP treatment for sleep apnea
CPAP: CPAP Treatment for 12 weeks
|
Mandibular Advancing Device
n=35 Participants
MAD treatment for sleep apnea
MAD: MAD Treatment for 12 weeks
|
|---|---|---|
|
Residual Apnea Hypopnea Index
|
3.9 events per hour
Standard Deviation 4.8
|
26.3 events per hour
Standard Deviation 25.6
|
SECONDARY outcome
Timeframe: 12 weeksHealth 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
Outcome measures
| Measure |
CPAP
n=35 Participants
CPAP treatment for sleep apnea
CPAP: CPAP Treatment for 12 weeks
|
Mandibular Advancing Device
n=35 Participants
MAD treatment for sleep apnea
MAD: MAD Treatment for 12 weeks
|
|---|---|---|
|
Health Outcomes
Epworth Sleepiness Scale
|
9.4 units on a scale
Standard Deviation 4.7
|
9.5 units on a scale
Standard Deviation 4.9
|
|
Health Outcomes
PTSD Checklist
|
49.9 units on a scale
Standard Deviation 15.4
|
50.03 units on a scale
Standard Deviation 13.64
|
|
Health Outcomes
Pitt sleep quality index
|
17.3 units on a scale
Standard Deviation 0.2
|
17.3 units on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: 12 weeksThe 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).
Outcome measures
| Measure |
CPAP
n=35 Participants
CPAP treatment for sleep apnea
CPAP: CPAP Treatment for 12 weeks
|
Mandibular Advancing Device
n=35 Participants
MAD treatment for sleep apnea
MAD: MAD Treatment for 12 weeks
|
|---|---|---|
|
General Health SF-36
|
49.33 units on a scale
Standard Deviation 17.09
|
50.58 units on a scale
Standard Deviation 15.45
|
SECONDARY outcome
Timeframe: 12 weekscomparison of the number of hours per night used while on CPAP versus MAD
Outcome measures
| Measure |
CPAP
n=35 Participants
CPAP treatment for sleep apnea
CPAP: CPAP Treatment for 12 weeks
|
Mandibular Advancing Device
n=35 Participants
MAD treatment for sleep apnea
MAD: MAD Treatment for 12 weeks
|
|---|---|---|
|
Adherence to Therapy
|
3.4 hours per night
Standard Deviation 2.48
|
5.66 hours per night
Standard Deviation 2.43
|
Adverse Events
CPAP
Mandibular Advancing Device
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CPAP
n=35 participants at risk
CPAP treatment for sleep apnea
CPAP: CPAP Treatment for 12 weeks
|
Mandibular Advancing Device
n=35 participants at risk
MAD treatment for sleep apnea
MAD: MAD Treatment for 12 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
mask discomfort
|
42.9%
15/35 • Number of events 15
|
0.00%
0/35
|
|
Respiratory, thoracic and mediastinal disorders
claustrophobia
|
31.4%
11/35 • Number of events 11
|
0.00%
0/35
|
|
Musculoskeletal and connective tissue disorders
Jaw pain
|
0.00%
0/35
|
25.7%
9/35 • Number of events 9
|
|
General disorders
Dry mouth
|
28.6%
10/35 • Number of events 10
|
17.1%
6/35 • Number of events 6
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place