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出境医 / 临床实验 / Apnea and Insomnia Relief Study (AIR)

Apnea and Insomnia Relief Study (AIR)

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).

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 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.
Study Design
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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
Actual Study Start Date : February 27, 2020
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : June 30, 2024
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Active Comparator: 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.
Behavioral: 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.

Outcome Measures
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.


Eligibility Criteria
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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 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
Contacts and Locations

Locations
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United States, California
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121
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
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date January 28, 2021
Actual Study Start Date  ICMJE February 27, 2020
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • CPAP Adherence [ Time Frame: Past 7 days, at 1 week after treatment ends ]
    Average daily CPAP use.
  • CPAP Adherence [ Time Frame: Past 7 days, at 3 months after treatment ends ]
    Average daily CPAP use.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Apnea and Insomnia Relief Study
Official Title  ICMJE Improving Sleep and Functioning in Veterans With Posttraumatic Stress Disorder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Sleep Apnea Syndromes
  • Insomnia Disorder
  • Stress Disorders, Post-Traumatic
Intervention  ICMJE
  • Behavioral: 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Apnea and Insomnia Relief (AIR)
  • Active Comparator: 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.
    Intervention: Behavioral: Sleep Education (SE)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 2, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2024
Estimated Primary Completion Date March 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04007796
Other Study ID Numbers  ICMJE D2952-W
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lizabeth A Goldstein, PhD San Francisco VA Medical Center, San Francisco, CA
PRS Account VA Office of Research and Development
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP