Trial Outcomes & Findings for Apnea and Insomnia Relief Study (NCT NCT04007796)

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

2026-01-14

Participant Flow

Participant milestones

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

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

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

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 ends

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

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)

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

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to 3 months after treatment ends

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

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks)

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

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to 3 months after treatment ends

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

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks)

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

Outcome data not reported

SECONDARY outcome

Timeframe: Past 7 days, at 1 week after treatment ends

Average daily CPAP use.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Past 7 days, at 3 months after treatment ends

Average daily CPAP use.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks)

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.

Outcome measures

Outcome data not reported

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

Dr. Liz Goldstein

San Francisco VA Health Care System

Phone: 415-694-3443

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place