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Apnea and Insomnia Relief Study (AIR)

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ClinicalTrials.gov Identifier: NCT04007796
Recruitment Status : Not yet recruiting
First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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).

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Insomnia Disorder Stress Disorders, Post-Traumatic Behavioral: Apnea and Insomnia Relief (AIR) Behavioral: Sleep Education (SE) Phase 2

Detailed Description:
This study is a randomized controlled trial of a behavioral sleep treatment improves functioning and sleep in Veterans with PTSD, sleep apnea, and insomnia. The treatment is delivered partially in person and partially 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial with participants assigned to one of two treatment groups in parallel for the duration of the study
Masking: Single (Outcomes Assessor)
Masking Description: The clinical interviewer conducting outcome-related interviews will be masked.
Primary Purpose: Treatment
Official Title: Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apnea and Insomnia Relief (AIR)
This treatment will be offered over six sessions. The first two appointments will be offered in-person and will last 60 minutes. The subsequent four 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.
Behavioral: Apnea and Insomnia Relief (AIR)
This treatment will be offered over six sessions. The first two appointments will be offered in-person and will last 60 minutes. The subsequent four 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.

Active Comparator: Sleep Education (SE)
The treatment will be offered over six sessions. The first two appointments will be offered in-person and will last 60 minutes. The subsequent four 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.
Behavioral: Sleep Education (SE)
The treatment will be offered over six sessions. The first two appointments will be offered in-person and will last 60 minutes. The subsequent four 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 Measures :
  1. World Health Organization Quality of Life (WHOQOL-BREF) [ Time Frame: Change from baseline to 1 week post-treatment (after 6 weeks) ]
    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.

  2. World Health Organization Quality of Life (WHOQOL-BREF) [ Time Frame: Change from baseline to 3 months after treatment ends ]
    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 :
  1. Functional Outcomes of Sleep Questionnaire (FOSQ-10) [ Time Frame: 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.

  2. Functional Outcomes of Sleep Questionnaire (FOSQ-10) [ Time Frame: 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.

  3. Insomnia Severity Index (ISI) [ Time Frame: 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.

  4. Insomnia Severity Index (ISI) [ Time Frame: 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.

  5. Total sleep time (actigraphy-based) [ Time Frame: 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.

  6. CPAP Adherence [ Time Frame: Past 7 days, at 1 week after treatment ends ]
    Average daily CPAP use.

  7. CPAP Adherence [ Time Frame: Past 7 days, at 3 months after treatment ends ]
    Average daily CPAP use.

  8. Clinician Administered PTSD Scale for DSM-5 (CAPS-5) [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Exclusion Criteria:

  • Psychosis or manic episode in last 5 years
  • Substance use disorder in past 6 months
  • Started or ended psychotherapy for a sleep disorder or mental health diagnosis within the last 1 month and do not plan to discontinue this treatment during the trial
  • Started or ended an antidepressant, anxiolytic, or sleep medication with the last 1 month and do not plan 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007796


Contacts
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Contact: Lizabeth A Goldstein, PhD (415) 221-4810 ext 25437 Lizabeth.Goldstein2@va.gov

Locations
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United States, California
San Francisco VA Medical Center, San Francisco, CA Not yet recruiting
San Francisco, California, United States, 94121
Contact: Lizabeth A Goldstein, PhD    415-221-4810 ext 25437    Lizabeth.Goldstein2@va.gov   
Principal Investigator: Lizabeth A Goldstein, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Lizabeth A Goldstein, PhD San Francisco VA Medical Center, San Francisco, CA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04007796     History of Changes
Other Study ID Numbers: D2952-W
First Posted: July 3, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by VA Office of Research and Development:
Sleep Apnea Syndromes
Sleep Apnea, Central
Sleep Apnea, Obstructive
Sleep Initiation and Maintenance Disorders
Insomnia
Insomnia Disorder
Stress Disorders, Post-Traumatic
PTSD
Veterans

Additional relevant MeSH terms:
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Disease
Apnea
Sleep Apnea Syndromes
Stress Disorders, Traumatic
Sleep Initiation and Maintenance Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Trauma and Stressor Related Disorders
Mental Disorders