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Apnea and Insomnia Relief Study (AIR)

Primary Purpose

Sleep Apnea Syndromes, Insomnia Disorder, Stress Disorders, Post-Traumatic

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Apnea and Insomnia Relief (AIR)
Sleep Education (SE)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring Sleep Apnea Syndromes, Sleep Apnea, Central, Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders, Insomnia, Insomnia Disorder, Stress Disorders, Post-Traumatic, PTSD, Veterans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veterans diagnosed with sleep apnea with Apnea Hypopnea Index of at least 5 via sleep study at San Francisco VA Healthcare System and recommended for PAP therapy
  • Meet DSM-5 Criteria for Posttraumatic Stress Disorder or subthreshold Posttraumatic Stress Disorder
  • Meet DSM-5 Criteria for Insomnia Disorder
  • Willing to attend all treatment and assessment appointments
  • English literacy and cognition sufficient to participate in treatment and assessment

Exclusion Criteria:

  • Psychosis or manic episode in last 5 years
  • Moderate or severe substance use disorder in past 6 months
  • Started or ended psychotherapy for a sleep disorder or mental health diagnosis within the last 1 month or plans to discontinue this treatment during the trial
  • Started or ended an antidepressant, anxiolytic, or sleep medication with the last 1 month or plans to discontinue this treatment during the trial
  • Prominent suicidal or homicidal ideation requiring alternative treatment for patient safety
  • Untreated sleep disorders that may interfere with successful treatment (up to discretion of Principal Investigator)
  • Having travel of personal plans that would disrupt regular treatment engagement (up to discretion of Principal Investigator)
  • Working night shifts or rotating shifts that include night shifts
  • Lack of stable housing
  • Pregnancy

Sites / Locations

  • San Francisco VA Medical Center, San Francisco, CARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apnea and Insomnia Relief (AIR)

Sleep Education (SE)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

World Health Organization Quality of Life (WHOQOL-BREF)
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.
World Health Organization Quality of Life (WHOQOL-BREF)
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.

Secondary Outcome Measures

Functional Outcomes of Sleep Questionnaire (FOSQ-10)
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.
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
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.
Insomnia Severity Index (ISI)
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.
Insomnia Severity Index (ISI)
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.
Total sleep time (actigraphy-based)
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.
CPAP Adherence
Average daily CPAP use.
CPAP Adherence
Average daily CPAP use.
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
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.

Full Information

First Posted
July 2, 2019
Last Updated
December 23, 2022
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04007796
Brief Title
Apnea and Insomnia Relief Study
Acronym
AIR
Official Title
Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2020 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether a behavioral sleep treatment improves functioning and sleep in Veterans with posttraumatic stress disorder (PTSD).
Detailed Description
This study is a randomized controlled trial of a behavioral sleep treatment to improve functioning and sleep in Veterans with PTSD, sleep apnea, and insomnia. The treatment is delivered via telehealth (video to home). The primary outcome for this study is quality of life. Other outcomes include sleep-related functioning, PTSD symptom severity, insomnia symptom severity, and CPAP adherence. Participants will also provide treatment feedback to aid in assessment of treatment feasibility and acceptability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Insomnia Disorder, Stress Disorders, Post-Traumatic
Keywords
Sleep Apnea Syndromes, Sleep Apnea, Central, Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders, Insomnia, Insomnia Disorder, Stress Disorders, Post-Traumatic, PTSD, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with participants assigned to one of two treatment groups in parallel for the duration of the study
Masking
Outcomes Assessor
Masking Description
The clinical interviewer conducting outcome-related interviews will be masked.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apnea and Insomnia Relief (AIR)
Arm Type
Experimental
Arm Description
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.
Arm Title
Sleep Education (SE)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Apnea and Insomnia Relief (AIR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Sleep Education (SE)
Intervention Description
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.
Primary Outcome Measure Information:
Title
World Health Organization Quality of Life (WHOQOL-BREF)
Description
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.
Time Frame
Change from baseline to 1 week post-treatment (after 6 weeks)
Title
World Health Organization Quality of Life (WHOQOL-BREF)
Description
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.
Time Frame
Change from baseline to 3 months after treatment ends
Secondary Outcome Measure Information:
Title
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Description
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.
Time Frame
Change from baseline to 1 week post-treatment (after 6 weeks)
Title
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Description
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.
Time Frame
Change from baseline to 3 months after treatment ends
Title
Insomnia Severity Index (ISI)
Description
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.
Time Frame
Change from baseline to 1 week post-treatment (after 6 weeks)
Title
Insomnia Severity Index (ISI)
Description
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.
Time Frame
Change from baseline to 3 months after treatment ends
Title
Total sleep time (actigraphy-based)
Description
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.
Time Frame
Change from baseline to 1 week post-treatment (after 6 weeks)
Title
CPAP Adherence
Description
Average daily CPAP use.
Time Frame
Past 7 days, at 1 week after treatment ends
Title
CPAP Adherence
Description
Average daily CPAP use.
Time Frame
Past 7 days, at 3 months after treatment ends
Title
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Description
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.
Time Frame
Change from baseline to 1 week post-treatment (after 6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans diagnosed with sleep apnea with Apnea Hypopnea Index of at least 5 via sleep study at San Francisco VA Healthcare System and recommended for PAP therapy Meet DSM-5 Criteria for Posttraumatic Stress Disorder or subthreshold Posttraumatic Stress Disorder Meet DSM-5 Criteria for Insomnia Disorder Willing to attend all treatment and assessment appointments English literacy and cognition sufficient to participate in treatment and assessment Exclusion Criteria: Psychosis or manic episode in last 5 years Moderate or severe substance use disorder in past 6 months Started or ended psychotherapy for a sleep disorder or mental health diagnosis within the last 1 month or plans to discontinue this treatment during the trial Started or ended an antidepressant, anxiolytic, or sleep medication with the last 1 month or plans to discontinue this treatment during the trial Prominent suicidal or homicidal ideation requiring alternative treatment for patient safety Untreated sleep disorders that may interfere with successful treatment (up to discretion of Principal Investigator) Having travel of personal plans that would disrupt regular treatment engagement (up to discretion of Principal Investigator) Working night shifts or rotating shifts that include night shifts Lack of stable housing Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lizabeth A Goldstein, PhD
Phone
(415) 221-4810
Ext
25437
Email
Lizabeth.Goldstein2@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lizabeth A Goldstein, PhD
Organizational Affiliation
San Francisco VA Medical Center, San Francisco, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco VA Medical Center, San Francisco, CA
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lizabeth A Goldstein, PhD
Phone
415-221-4810
Ext
25437
Email
Lizabeth.Goldstein2@va.gov
First Name & Middle Initial & Last Name & Degree
Lizabeth A Goldstein, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Apnea and Insomnia Relief Study

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