Trial Outcomes & Findings for Apnea and Insomnia Relief Study (NCT NCT04007796)
NCT ID: NCT04007796
Last Updated: 2026-03-12
Results Overview
This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Change from baseline to 1 week post-treatment (after 6 weeks)
Results posted on
2026-03-12
Participant Flow
Participant milestones
| Measure |
Apnea and Insomnia Relief (AIR)
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Apnea and Insomnia Relief (AIR): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
|
Sleep Education (SE)
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
Sleep Education (SE): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
17
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Apnea and Insomnia Relief (AIR)
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Apnea and Insomnia Relief (AIR): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
|
Sleep Education (SE)
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
Sleep Education (SE): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
|
|---|---|---|
|
Overall Study
Exclusion criterion met during the trial
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
One participant did not specify their race/ethnicity.
Baseline characteristics by cohort
| Measure |
Apnea and Insomnia Relief (AIR)
n=18 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Apnea and Insomnia Relief (AIR): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
|
Sleep Education (SE)
n=16 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
Sleep Education (SE): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.06 years
STANDARD_DEVIATION 12.19 • n=18 Participants
|
49.44 years
STANDARD_DEVIATION 12.16 • n=16 Participants
|
50.29 years
STANDARD_DEVIATION 12.02 • n=34 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=18 Participants
|
0 Participants
n=16 Participants
|
2 Participants
n=34 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=18 Participants
|
16 Participants
n=16 Participants
|
32 Participants
n=34 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Caucasian/White
|
11 Participants
n=17 Participants • One participant did not specify their race/ethnicity.
|
8 Participants
n=16 Participants • One participant did not specify their race/ethnicity.
|
19 Participants
n=33 Participants • One participant did not specify their race/ethnicity.
|
|
Race/Ethnicity, Customized
Race/ethnicity · Black or African American
|
2 Participants
n=17 Participants • One participant did not specify their race/ethnicity.
|
2 Participants
n=16 Participants • One participant did not specify their race/ethnicity.
|
4 Participants
n=33 Participants • One participant did not specify their race/ethnicity.
|
|
Race/Ethnicity, Customized
Race/ethnicity · Asian
|
2 Participants
n=17 Participants • One participant did not specify their race/ethnicity.
|
3 Participants
n=16 Participants • One participant did not specify their race/ethnicity.
|
5 Participants
n=33 Participants • One participant did not specify their race/ethnicity.
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic or Latino
|
1 Participants
n=17 Participants • One participant did not specify their race/ethnicity.
|
2 Participants
n=16 Participants • One participant did not specify their race/ethnicity.
|
3 Participants
n=33 Participants • One participant did not specify their race/ethnicity.
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other
|
1 Participants
n=17 Participants • One participant did not specify their race/ethnicity.
|
1 Participants
n=16 Participants • One participant did not specify their race/ethnicity.
|
2 Participants
n=33 Participants • One participant did not specify their race/ethnicity.
|
|
Region of Enrollment
United States
|
18 Participants
n=18 Participants
|
16 Participants
n=16 Participants
|
34 Participants
n=34 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks)Population: An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment.
This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain.
Outcome measures
| Measure |
Apnea and Insomnia Relief (AIR)
n=18 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Apnea and Insomnia Relief (AIR): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
|
Sleep Education (SE)
n=16 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
Sleep Education (SE): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
|
|---|---|---|
|
World Health Organization Quality of Life (WHOQOL-BREF)
Baseline
|
11.26 units on a scale
Standard Deviation 1.91
|
9.75 units on a scale
Standard Deviation 2.95
|
|
World Health Organization Quality of Life (WHOQOL-BREF)
Post-Treatment
|
12.78 units on a scale
Standard Deviation 2.04
|
10.84 units on a scale
Standard Deviation 2.80
|
PRIMARY outcome
Timeframe: Change from baseline to 3 months after treatment endsPopulation: An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment.
This 26-item self-report questionnaire measures the following four broad domains: physical health, psychological health, social relationships, and environment. Each item has five response options, with higher scores indicating greater health. Mean scores are calculated for each domain and then multiplied by four (range of 4-20 for each domain) to enable comparisons with the WHOQOL-100. The primary outcome is the psychological domain.
Outcome measures
| Measure |
Apnea and Insomnia Relief (AIR)
n=18 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Apnea and Insomnia Relief (AIR): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
|
Sleep Education (SE)
n=16 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
Sleep Education (SE): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
|
|---|---|---|
|
World Health Organization Quality of Life (WHOQOL-BREF)
Baseline
|
11.26 units on a scale
Standard Deviation 1.91
|
9.75 units on a scale
Standard Deviation 2.95
|
|
World Health Organization Quality of Life (WHOQOL-BREF)
3-Month Follow-Up
|
12.47 units on a scale
Standard Deviation 2.55
|
10.71 units on a scale
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks)Population: An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment.
This 10-item self-report measure evaluates functional status. In particular, items prompt participants to rate the extent to which they experience difficulty completing various tasks due to sleepiness or fatigue. Responses to items range from 0 to 4. Total scores range from 5-20. Higher scores indicate better functioning.
Outcome measures
| Measure |
Apnea and Insomnia Relief (AIR)
n=18 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Apnea and Insomnia Relief (AIR): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
|
Sleep Education (SE)
n=16 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
Sleep Education (SE): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
|
|---|---|---|
|
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Baseline
|
13.22 units on a scale
Standard Deviation 2.28
|
11.58 units on a scale
Standard Deviation 3.51
|
|
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Post-Treatment
|
15.08 units on a scale
Standard Deviation 3.18
|
13.47 units on a scale
Standard Deviation 4.19
|
SECONDARY outcome
Timeframe: Change from baseline to 3 months after treatment endsPopulation: An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment.
This 10-item self-report measure evaluates functional status. In particular, items prompt participants to rate the extent to which they experience difficulty completing various tasks due to sleepiness or fatigue. Responses to items range from 0 to 4. Total scores range from 5-20. Higher scores indicate better functioning.
Outcome measures
| Measure |
Apnea and Insomnia Relief (AIR)
n=18 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Apnea and Insomnia Relief (AIR): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
|
Sleep Education (SE)
n=16 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
Sleep Education (SE): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
|
|---|---|---|
|
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Baseline
|
13.22 units on a scale
Standard Deviation 2.28
|
11.58 units on a scale
Standard Deviation 3.51
|
|
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
3-Month Follow-Up
|
14.52 units on a scale
Standard Deviation 3.01
|
13.50 units on a scale
Standard Deviation 3.67
|
SECONDARY outcome
Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks)Population: An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment.
This seven-item self-report scale assesses severity of insomnia. Responses to items range from 0 to 4. Total scores range from 0 to 28. Higher scores indicate greater symptom severity.
Outcome measures
| Measure |
Apnea and Insomnia Relief (AIR)
n=18 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Apnea and Insomnia Relief (AIR): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
|
Sleep Education (SE)
n=16 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
Sleep Education (SE): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
|
|---|---|---|
|
Insomnia Severity Index (ISI)
Baseline
|
19.11 units on a scale
Standard Deviation 4.09
|
19.06 units on a scale
Standard Deviation 4.70
|
|
Insomnia Severity Index (ISI)
Post-Treatment
|
11.94 units on a scale
Standard Deviation 6.00
|
15.00 units on a scale
Standard Deviation 6.41
|
SECONDARY outcome
Timeframe: Change from baseline to 3 months after treatment endsPopulation: An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment.
This seven-item self-report scale assesses severity of insomnia. Responses to items range from 0 to 4. Total scores range from 0 to 28. Higher scores indicate greater symptom severity.
Outcome measures
| Measure |
Apnea and Insomnia Relief (AIR)
n=18 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Apnea and Insomnia Relief (AIR): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
|
Sleep Education (SE)
n=16 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
Sleep Education (SE): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
|
|---|---|---|
|
Insomnia Severity Index (ISI)
Baseline
|
19.11 units on a scale
Standard Deviation 4.09
|
19.06 units on a scale
Standard Deviation 4.70
|
|
Insomnia Severity Index (ISI)
3-Month Follow-Up
|
12.47 units on a scale
Standard Deviation 5.66
|
14.64 units on a scale
Standard Deviation 6.73
|
SECONDARY outcome
Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks)Population: An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment.
An actigraph will be used to determine total sleep time. An actigraph is a validated objective sleep measurement device commonly used outside the laboratory setting to detect movement and infer sleep and wake based on wrist activity.
Outcome measures
| Measure |
Apnea and Insomnia Relief (AIR)
n=7 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Apnea and Insomnia Relief (AIR): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
|
Sleep Education (SE)
n=6 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
Sleep Education (SE): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
|
|---|---|---|
|
Total Sleep Time (Actigraphy-based)
Baseline
|
417.43 minutes
Standard Deviation 69.62
|
373.71 minutes
Standard Deviation 35.94
|
|
Total Sleep Time (Actigraphy-based)
Post-Treatment
|
380.50 minutes
Standard Deviation 75.71
|
367.82 minutes
Standard Deviation 58.89
|
SECONDARY outcome
Timeframe: Past 7 days, at 1 week after treatment endsPopulation: An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment.
Average daily CPAP use.
Outcome measures
| Measure |
Apnea and Insomnia Relief (AIR)
n=17 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Apnea and Insomnia Relief (AIR): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
|
Sleep Education (SE)
n=15 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
Sleep Education (SE): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
|
|---|---|---|
|
CPAP Adherence
|
163.94 minutes
Standard Deviation 180.17
|
75.33 minutes
Standard Deviation 116.39
|
SECONDARY outcome
Timeframe: Past 7 days, at 3 months after treatment endsPopulation: An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment.
Average daily CPAP use.
Outcome measures
| Measure |
Apnea and Insomnia Relief (AIR)
n=17 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Apnea and Insomnia Relief (AIR): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
|
Sleep Education (SE)
n=15 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
Sleep Education (SE): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
|
|---|---|---|
|
CPAP Adherence
|
148.71 minutes
Standard Deviation 180.51
|
112.67 minutes
Standard Deviation 237.30
|
SECONDARY outcome
Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks)Population: An intent-to-treat analysis was conducted using all available data from eligible participants who started treatment.
This 30-item semi-structured interview provides a dimensional and categorical measure of PTSD. The severity score is based on frequency and intensity of PTSD symptoms. Categorically, it determines presence of both lifetime and current PTSD. Current and lifetime PTSD will be assessed at pre-treatment. Only current PTSD will be assessed at post-treatment. This interview also assesses the onset and duration of symptoms, distress, impact of symptoms on functioning (social and occupational), change in symptoms since a previous administration, response validity, and dissociative subtype of PTSD. Total score ranging from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.
Outcome measures
| Measure |
Apnea and Insomnia Relief (AIR)
n=18 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Apnea and Insomnia Relief (AIR): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
|
Sleep Education (SE)
n=16 Participants
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
Sleep Education (SE): This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
|
|---|---|---|
|
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Baseline
|
28.78 units on a scale
Standard Deviation 6.18
|
29.19 units on a scale
Standard Deviation 7.15
|
|
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Post-Treatment
|
19.12 units on a scale
Standard Deviation 8.85
|
26.13 units on a scale
Standard Deviation 10.81
|
Adverse Events
Apnea and Insomnia Relief (AIR)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sleep Education (SE)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place