Trial Outcomes & Findings for Remote Diagnosis and Management of Obstructive Sleep Apnea (NCT NCT03007745)
NCT ID: NCT03007745
Last Updated: 2025-05-20
Results Overview
FOSQ-10 score ranges between 5 and 20 units; there is not threshold for normality; a higher score indicates higher functional outcome. Outcome Measure: Change from baseline in Functional Outcome of Sleep Questionnaire - Short Form (FOSQ-10), a self-administered disease specific quality of life questionnaire, in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data). A change in 1 unit is felt to indicate clinical significance.
COMPLETED
NA
435 participants
3 months
2025-05-20
Participant Flow
Participant milestones
| Measure |
REVAMP
Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
In-person Management
Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
|---|---|---|
|
Overall Study
STARTED
|
218
|
217
|
|
Overall Study
COMPLETED
|
85
|
114
|
|
Overall Study
NOT COMPLETED
|
133
|
103
|
Reasons for withdrawal
| Measure |
REVAMP
Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
In-person Management
Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
|---|---|---|
|
Overall Study
Sleep test negative for OSA
|
53
|
49
|
|
Overall Study
Physician Decision
|
6
|
9
|
|
Overall Study
Withdrawal by Subject
|
38
|
16
|
|
Overall Study
Lost to Follow-up
|
19
|
25
|
|
Overall Study
Unable to login to website
|
17
|
4
|
Baseline Characteristics
Missing data
Baseline characteristics by cohort
| Measure |
REVAMP
n=218 Participants
Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
In-person Management
n=217 Participants
Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
Total
n=435 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.25 years
STANDARD_DEVIATION 13.31 • n=218 Participants
|
47.25 years
STANDARD_DEVIATION 13.31 • n=217 Participants
|
46.76 years
STANDARD_DEVIATION 13.20 • n=435 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=218 Participants
|
44 Participants
n=217 Participants
|
88 Participants
n=435 Participants
|
|
Sex: Female, Male
Male
|
174 Participants
n=218 Participants
|
173 Participants
n=217 Participants
|
347 Participants
n=435 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
3 Participants
n=218 Participants
|
4 Participants
n=217 Participants
|
7 Participants
n=435 Participants
|
|
Race/Ethnicity, Customized
Asian
|
15 Participants
n=218 Participants
|
10 Participants
n=217 Participants
|
25 Participants
n=435 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian
|
2 Participants
n=218 Participants
|
3 Participants
n=217 Participants
|
5 Participants
n=435 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
92 Participants
n=218 Participants
|
111 Participants
n=217 Participants
|
203 Participants
n=435 Participants
|
|
Race/Ethnicity, Customized
White
|
95 Participants
n=218 Participants
|
78 Participants
n=217 Participants
|
173 Participants
n=435 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
11 Participants
n=218 Participants
|
11 Participants
n=217 Participants
|
22 Participants
n=435 Participants
|
|
Region of Enrollment
United States
|
218 Participants
n=218 Participants
|
217 Participants
n=217 Participants
|
435 Participants
n=435 Participants
|
|
Body Mass Index (BMI)
|
32.53 kg/m2
STANDARD_DEVIATION 5.46 • n=215 Participants • Missing data
|
32.87 kg/m2
STANDARD_DEVIATION 5.99 • n=207 Participants • Missing data
|
32.70 kg/m2
STANDARD_DEVIATION 5.72 • n=422 Participants • Missing data
|
|
Apnea-hypopnea index (AHI)
|
18.54 number of events/hour
STANDARD_DEVIATION 24.58 • n=167 Participants • missing data
|
20.71 number of events/hour
STANDARD_DEVIATION 20.68 • n=175 Participants • missing data
|
19.65 number of events/hour
STANDARD_DEVIATION 22.66 • n=342 Participants • missing data
|
|
Oxygen desaturation index
|
15.56 index
STANDARD_DEVIATION 22.93 • n=167 Participants • Missing data
|
17.7 index
STANDARD_DEVIATION 21.22 • n=171 Participants • Missing data
|
16.60 index
STANDARD_DEVIATION 21.99 • n=338 Participants • Missing data
|
|
Functional Outcome of Sleep Questionnaire-10
|
12.51 units on a scale
STANDARD_DEVIATION 3.86 • n=141 Participants • missing data
|
12.92 units on a scale
STANDARD_DEVIATION 3.69 • n=188 Participants • missing data
|
12.75 units on a scale
STANDARD_DEVIATION 3.77 • n=329 Participants • missing data
|
|
Epworth Sleepiness Scale
|
12.07 units on a scale
STANDARD_DEVIATION 5.56 • n=141 Participants • missing data
|
12.28 units on a scale
STANDARD_DEVIATION 5.70 • n=184 Participants • missing data
|
12.19 units on a scale
STANDARD_DEVIATION 5.63 • n=325 Participants • missing data
|
|
Insomnia Severity Index
|
17.13 units on a scale
STANDARD_DEVIATION 6.19 • n=141 Participants • missing data
|
16.75 units on a scale
STANDARD_DEVIATION 6.78 • n=182 Participants • missing data
|
16.92 units on a scale
STANDARD_DEVIATION 6.53 • n=323 Participants • missing data
|
|
Pittsburgh Sleep Quality Index
|
13.52 units on a scale
STANDARD_DEVIATION 3.52 • n=141 Participants • missing data
|
13.74 units on a scale
STANDARD_DEVIATION 3.52 • n=170 Participants • missing data
|
13.63 units on a scale
STANDARD_DEVIATION 3.52 • n=311 Participants • missing data
|
|
Medical Outcomes Study Short Form 12 (physical)
|
24.68 units on a scale
STANDARD_DEVIATION 0.40 • n=133 Participants • missing data
|
24.65 units on a scale
STANDARD_DEVIATION 0.39 • n=177 Participants • missing data
|
24.66 units on a scale
STANDARD_DEVIATION 0.40 • n=310 Participants • missing data
|
|
Medical Outcomes Study Short Form (mental)
|
18.24 units on a scale
STANDARD_DEVIATION 0.78 • n=133 Participants • missing data
|
18.39 units on a scale
STANDARD_DEVIATION 0.75 • n=177 Participants • missing data
|
18.32 units on a scale
STANDARD_DEVIATION 0.77 • n=310 Participants • missing data
|
|
European Quality of Life Visual Analogue Scale (EurQol-5D VAS)
|
67.42 units on a scale
STANDARD_DEVIATION 16.71 • n=126 Participants • missing data
|
64.97 units on a scale
STANDARD_DEVIATION 18.88 • n=183 Participants • missing data
|
65.97 units on a scale
STANDARD_DEVIATION 18.04 • n=309 Participants • missing data
|
|
Center for Epidemiologic Studies Depression questionnaire (CES-D)
|
13.38 units on a scale
STANDARD_DEVIATION 7.59 • n=142 Participants • Missing data
|
12.66 units on a scale
STANDARD_DEVIATION 6.49 • n=186 Participants • Missing data
|
12.97 units on a scale
STANDARD_DEVIATION 6.99 • n=328 Participants • Missing data
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)
FOSQ-10 score ranges between 5 and 20 units; there is not threshold for normality; a higher score indicates higher functional outcome. Outcome Measure: Change from baseline in Functional Outcome of Sleep Questionnaire - Short Form (FOSQ-10), a self-administered disease specific quality of life questionnaire, in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data). A change in 1 unit is felt to indicate clinical significance.
Outcome measures
| Measure |
REVAMP
n=47 Participants
Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
In-person Management
n=91 Participants
Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
|---|---|---|
|
Functional Outcome of Sleep Questionnaire - Short Form (FOSQ-10)
|
1.96 score on a scale
Standard Deviation 3.08
|
1.73 score on a scale
Standard Deviation 3.97
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)
Epworth Sleepiness Scale score ranges from 0 to 24 units; a value less than 11 is considered within normal range; a value of 11 or greater is considered to indicate the presence of subjective daytime sleepiness. Outcome measure: Change from baseline in the Epworth Sleepiness Scale (ESS), a self-administered subjective measure of daytime sleepiness, in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data). A score change of 2 units is felt to indicate clinical significance.
Outcome measures
| Measure |
REVAMP
n=48 Participants
Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
In-person Management
n=91 Participants
Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
|---|---|---|
|
Epworth Sleepiness Scale (ESS)
|
-3.31 score on a scale
Standard Deviation 4.86
|
-3.51 score on a scale
Standard Deviation 5.52
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)
Medical Outcomes Study Short Form (physical) score ranges from 0 to 100. A higher score indicates a higher level of health or functioning. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health. Outcome measure: Change from baseline in physical component of the Health Survey Short Form-12 (SF-12), a self administered quality of life questionnaire, in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data).
Outcome measures
| Measure |
REVAMP
n=46 Participants
Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
In-person Management
n=84 Participants
Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
|---|---|---|
|
Heath Survey Short Form - 12 (SF-12) Physical Component
|
0.04 score on a scale
Standard Deviation 0.33
|
-0.05 score on a scale
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)
Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item standard instrument devised using items from 5 validated depression scales. Likert-style responses for each symptom indicates how often in the past week the subject has experienced the symptom. Scores on the CES-DC range from 0 to 60, in which higher scores suggest a greater presence of depressive symptoms. A score of 15 or higher is interpreted to indicate a risk for depression. Outcome measure: Change from baseline in Center for Epidemiological Studies Depression questionnaire (CES-D), a self-administered assessment of depression, in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)
Outcome measures
| Measure |
REVAMP
n=45 Participants
Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
In-person Management
n=91 Participants
Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
|---|---|---|
|
Center for Epidemiological Studies Depression Questionnaire (CES-D)
|
-2.76 score on a scale
Standard Deviation 4.73
|
-2.38 score on a scale
Standard Deviation 5.20
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Change from baseline in subjects initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)
Insomnia Severity Index scores range from 0 to 28 units with higher values indicating greater severity. Scores less than 8 are considered in the normal range. Scores between 8 and 14 are considered subthreshold insomnia. Scores between 15 and 21 are considered clinical insomnia of moderate severity and scores between 22 and 28 are considered severe clinical insomnia. Outcome measure: Change from baseline of the Insomnia Severity Index (ISI), a aelf-administered assessment of insomnia, in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)
Outcome measures
| Measure |
REVAMP
n=47 Participants
Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
In-person Management
n=89 Participants
Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
|---|---|---|
|
Insomnia Severity Index (ISI)
|
-5.94 score on a scale
Standard Deviation 6.17
|
-5.60 score on a scale
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Veterans randomized to REVAMP vs In-person management. The reduced number of participants analyzed was due to missing data. In particular, many participants in the REVAMP arm failed to complete the on-line HUI questionnaire.
Health Utilities Index (HUI-2), a self-administered questionnaire on overall functional health, in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data). HUI-2 classification system consists of 7 attributes including sensation, mobility, emotion, cognition, self-care, pain and fertility. HUI-2 utility values range from -0.03 to 1.00. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. To calculate a health utility score, health states for each response are converted using a look-up table and mathematical formula.
Outcome measures
| Measure |
REVAMP
n=10 Participants
Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
In-person Management
n=72 Participants
Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
|---|---|---|
|
Health Utilities Index (HUI)
|
0.7036 score on a scale
Standard Deviation 0.2729
|
0.7165 score on a scale
Standard Deviation 0.2127
|
SECONDARY outcome
Timeframe: 3 monthsEurQol-5D VAS is a visual vertical graduated analogue scale (ranging from 1 to 100) on which the participant self-rates health status. The score is reported as the units on the scale. Higher values represent a better health status. The EurQol-5D does not have a cut-off threshold to distinguish good versus poor health status. Outcome measure: Change from baseline in the EurQol-5D VAS score in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data).
Outcome measures
| Measure |
REVAMP
n=11 Participants
Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
In-person Management
n=77 Participants
Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
|---|---|---|
|
EuroQol (EQ-5D) VAS
|
68.82 score on a scale
Standard Deviation 25.34
|
67.32 score on a scale
Standard Deviation 20.85
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Total client score in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data) who completed the self-administered questionnaire.
WAI-SR is the 12-item questionnaire to assess three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of confidence, trust, comfort, and acceptance. Scores of each of the three key aspects range from 5 to 25 and the total WAI-SR score is the sum of the three subscored (maximum 75). Higher scores indicate greater alliance. Outcome measure: Assessment of participant-rated alliance with the practitioner in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)
Outcome measures
| Measure |
REVAMP
n=8 Participants
Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
In-person Management
n=74 Participants
Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
|---|---|---|
|
Worker Alliance Inventory - Short Revised (WAI-SR)
|
56.38 score on a scale
Standard Deviation 19.32
|
64.68 score on a scale
Standard Deviation 12.73
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: CSQ-8 score of participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)
Client Satisfaction Questionnaire (CSQ-8) is an 8-item, self-administered structured survey used to assess level of satisfaction with care. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
Outcome measures
| Measure |
REVAMP
n=18 Participants
Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
In-person Management
n=74 Participants
Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
|---|---|---|
|
Client Satisfaction Questionnaire (CSQ-8)
|
19.44 score on a scale
Standard Deviation 1.46
|
19.84 score on a scale
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data)
Objective assessment of adherence to CPAP treatment; average daily use over all days (hours)
Outcome measures
| Measure |
REVAMP
n=85 Participants
Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
In-person Management
n=114 Participants
Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
|---|---|---|
|
Adherence to Autoadjusting CPAP Treatment
|
3.29 hours per day
Standard Deviation 2.65
|
2.91 hours per day
Standard Deviation 2.59
|
Adverse Events
REVAMP
In-person Management
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
REVAMP
n=218 participants at risk
Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
In-person Management
n=217 participants at risk
Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.
autoadjusting continuous positive airway pressure: Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
CPAP mask irritation
|
0.00%
0/218 • Baseline, 1 month and 3 months
Adverse events collected at each scheduled participant encounter and whenever participant contacted research team to report an adverse event.
|
0.46%
1/217 • Number of events 1 • Baseline, 1 month and 3 months
Adverse events collected at each scheduled participant encounter and whenever participant contacted research team to report an adverse event.
|
|
Musculoskeletal and connective tissue disorders
Elective knee surgery
|
0.00%
0/218 • Baseline, 1 month and 3 months
Adverse events collected at each scheduled participant encounter and whenever participant contacted research team to report an adverse event.
|
0.46%
1/217 • Number of events 1 • Baseline, 1 month and 3 months
Adverse events collected at each scheduled participant encounter and whenever participant contacted research team to report an adverse event.
|
Additional Information
Samuel T. Kuna, MD
Corporal Michael J. Crescenz VA Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place