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Obstructive Sleep ApneaNCT02641496

Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD

A study testing CBT-OSA and Sleep Education in people with Obstructive Sleep Apnea and PTSD, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Approximately 20 million Americans suffer from Obstructive Sleep Apnea (OSA) creating risks for major health problems, including dementia, heart attack, and stroke. Obesity, a growing problem for Americans and Veterans alike, is the greatest risk factor for the development of OSA. Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
What is being tested?
CBT-OSA and Sleep Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteUnited States
Study dates
1 Jan 2017to 31 Dec 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or Female Veterans of any racial or ethnic group
  • Age 18 years old and older
  • OSA diagnosis by a board-certified Sleep Medicine physician
  • Have PTSD
  • Capable of giving informed consent for the study; able to read and write English; willing and able to comply with study requirements and restrictions
  • Not have a cognitive disorder
  • Sufficient visual and auditory acuity for cognitive testing
  • No new medication(s) within the prior 1 month. If on a non-excluded medication for a non-excluded condition, the medication regimen will be stable (no changes in dose) for at least 1 month prior to baseline (including anti-hypertensive and diabetic medications).

Who cannot join

  • Sleep
  • Current CPAP usage, home oxygen therapy, tracheotomy or past corrective surgery for OSA (e.g., uvulopalatopharyngo-plasty, midline glossectomy, or lingualplasty).
  • Diagnosis of Central Sleep Apnea (CSA)
  • Comorbid sleep disorder
  • Working night, rotating or split [period of work, followed by break, and then return to work]; shift work within 1-month of screening or plan to work these shifts during study; Occupations where participants regularly experience jet lag or have irregular work schedules.
  • Other Medical
Show all 24Show fewer
  • Unstable or moderate to severe chronic illness including systolic congestive heart failure, uncontrolled asthma, severe liver disease, end stage renal disease requiring hemodialysis or history of systemic illness affecting central nervous system (CNS) function (e.g. liver failure, kidney failure, congestive heart failure, systemic cancer).
  • Any current clinically significant cardiovascular, respiratory, neurologic, hepatic, hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently controlled and stable. Any solid organ transplantation.
  • Known or suspected neuromuscular disease (e.g. amyotrophic lateral sclerosis, spinal cord injury)
  • History of head injury within past year, or history of loss of consciousness > 24 hours
  • History of other neurological disease
  • Certain medications
  • Judged by the investigators to be unable or unlikely to follow the study protocol.
  • Psychiatric
  • Primary psychotic disorder
  • Bipolar disorder
  • Prominent suicidal or homicidal ideation
  • Current exposure to trauma, or exposure to trauma in the past 3 months
  • Some substance use
  • Presence of acute or unstable psychiatric condition(s) that requires referral for treatment.
  • Current or expected cognitive behavior therapy for another condition (e.g. insomnia, anxiety).
  • Other
  • A clinical history or participation in other research that would interfere with the objectives of this study.
  • Any other medical, social, or geographical factor that would make it unlikely that the participant would comply with the study procedures.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1290

Other trials in United States

About this study

Approximately 20 million Americans suffer from Obstructive Sleep Apnea (OSA) creating risks for major health problems, including dementia, heart attack, and stroke. Obesity, a growing problem for Americans and Veterans alike, is the greatest risk factor for the development of OSA. Male gender and smoking, other OSA risk factors, are common in Veterans. Given the high comorbidity of these risk factors in Veterans, OSA presents a significant health burden to Veterans. The investigators' prior work provides evidence that OSA occurs in up to 69% of Vietnam-era Veterans with Posttraumatic Stress Disorder (PTSD). OSA is easily treated; however, 15-30% of OSA patients are non-compliant with continuous positive airway pressure (CPAP), the standard OSA treatment. The proposed research aims to facilitate adherence to CPAP treatment by testing a novel cognitive-behavioral therapy intervention in Veterans with PTSD. If successful, it may represent an approach that could be applied to the rehabilitation of other chronic conditions with similar barriers to care.

Read the detailed description

GOALS AND EXPECTED OUTCOMES OF THE PROPOSED RESEARCH The purpose of this proposal is to test a novel cognitive-behavioral therapy (CBT) intervention to increase continuous positive airway pressure (CPAP) treatment adherence for PTSD Veterans with a diagnosis of obstructive sleep apnea (OSA). PTSD is a common, debilitating psychiatric consequence of exposure to trauma and a source of significant disability among U.S. war Veterans. The largest epidemiologic study of PTSD in Vietnam Veterans estimates that 15% of Vietnam Veterans suffer from PTSD [3]. The investigators' research on OSA in Vietnam era Veterans found that 69% of the Veterans in the sample had an Apnea-Hypopnea Index (AHI) 10 [4]. OSA is likely present in 50% of middle-aged and older VA patients [4, 5]. The recurrent hypoxemia and sleep fragmentation associated with OSA can lead to neural injury and functional impairment. Efficacious treatments are available for OSA (e.g., CPAP); however, Veterans with OSA frequently fail to use them [4, 6, 7], leaving these Veterans at risk for cognitive dysfunction [8], deterioration of physical health [9], and negative functional outcomes [10]. The investigators' long-term goal is to improve Veterans' functional outcomes by improving adherence to CPAP. If this intervention proves successful, it may represent an approach that could be applied to the rehabilitation of other chronic conditions with similar barriers to care.

RESEARCH DESIGN AND STRATEGY The reasons for low CPAP adherence include barriers related to discomfort in using CPAP and psychological barriers to behavior change [11]. A CBT treatment to improve CPAP adherence, CBT-OSA, has been successfully applied in civilian randomized controlled trials (RCTs) [12, 13]. The proposed VA intervention would involve delivery of CBT-OSA to PTSD Veterans to foster long-term CPAP adherence. The CBT-OSA treatment would build on the Veterans Integrated Services Network 21 (VISN) Mental Illness Research, Education and Clinical Center's (MIRECC) expertise in CBT interventions [e.g., VA rollout of CBT-Insomnia] as well as on the investigators' current research on PTSD Veterans with OSA. In this sample, the vast majority were not diagnosed with OSA prior to study entry; however, 69% of the participants had an Apnea-Hypopnea Index (AHI) 10 [4]. Of the Veterans previously diagnosed with OSA, 63% were not using their CPAP. Thus, CPAP adherence treatment for PTSD Veterans is the next logical step in the investigators' research. Specifically, the investigators propose a 1-year parallel-group RCT involving 120 PTSD Veterans with a diagnosis of OSA. All participants will receive treatment as usual in VA Pulmonary Service. Participants in the active arm will receive CBT-OSA from a trained Clinical Psychologist. The other arm will receive individual Education based treatment, but not CBT-OSA. Participants in both arms will receive weekly, individual sessions during the first 4 weeks of CPAP treatment and 4 booster sessions during the 1-year protocol. These two arms will be referred to hereafter as the CBT-OSA and the Education groups.

*The investigators will add telehealth treatment as an option for participants due to the COVID-19 pandemic. Research visits may be conducted either in-person or via telehealth (e.g., via video or telephone). Telehealth sessions are subject to approval by the research team. Videoconferencing in particular, requires certain features such as hardware, internet accessibility, and telephone capability.

HYPOTHESES

Hypothesis 1. (Primary) Effect of CBT on CPAP usage. The investigators hypothesize that the CBT-OSA group will use CPAP more hours per night on average than the Education group. ANCOVA will be used to test group differences over time in hours of "mask-on" CPAP usage per night. [Primary endpoint: mean of Days 335-365.]

Hypothesis 2. (Secondary) Effect of CBT on Self-reported Everyday Activities, Mood and Quality of Life. The investigators hypothesize that after initiating CPAP treatment, Veterans in the CBT-OSA group will report more improvement in the ease of performing everyday activities compared to that reported by those in the Education group. ANCOVA will be used to test group differences over time in the total score on the Functional Outcomes of Sleep Questionnaire (FOSQ; [14], at Days 0, 21, 365 (endpoint).

Hypothesis 3. (Secondary) Effect of CBT on Cognitive Outcomes. The investigators hypothesize that the CBT-OSA group will have better cognitive outcomes than the Education group over time. ANCOVA will be applied to the Rey Auditory Verbal Learning Test, Delayed Recall Score with the primary endpoint at Day 365.

Hypothesis 4. (Secondary) Effect of CBT on PTSD. The investigators hypothesize that the CBT-OSA group will have fewer PTSD symptoms than the Education group over time. ANCOVA will be used to test group differences over time in the total score on the PTSD Checklist for DSM-5 (PCL-5), measured at Days 0, 21, 365. Primary endpoint is Day 365.

HOW THE PROPOSED WORK WILL ADDRESS LONGER-TERM GOALS This research fits the VA's goal to reduce functional disabilities in PTSD Veterans with chronic medical conditions. It is designed to not only determine the benefit of this intervention overall, but also to determine in which Veterans CBT-OSA works best. The dataset collected will enable researchers to troubleshoot the intervention and propose improved interventions.

Being tested
CBT-OSA, Sleep Education
Keywords
Obstructive Sleep Apnea, PTSD, Posttraumatic Stress Disorder, Cognitive Behavioral Therapy, Continuous Positive Airway Pressure, CPAP, Cognition, Memory, Quality of Life, Self Efficacy, CBT, OSA, Sleep Apnea, Education, Psychotherapy, Post Traumatic Stress Disorder, Post-Traumatic Stress Disorder, Therapy
Medical subject headings
Sleep Apnea, Obstructive, Stress Disorders, Post-Traumatic, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT-OSABehavioural

    CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a CPAP machine.

  • Sleep EducationBehavioural

    The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene.

Study groups in NCT02641496
Study groupRoleWhat they receive
CBT-OSAExperimentalCBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a CPAP machine.
Receives: Behavioral: CBT-OSA
Sleep EducationActive comparatorThe Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene.
Receives: Behavioral: Sleep Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time in Minutes of "mask-on" Positive Airway Pressure (PAP) Machine Usage Per Night

    The PAP machine will measure average PAP use in minutes at two timepoints: first 30 days (encompassing the first four weekly treatment sessions) and the last 30 days (final 30 days of the year long study).

    Measured: Treatment 1 to Treatment 4 (approximately first 30 days of treatment) and Last 30 Days of 1 Year Study

Secondary outcomes (3)
  1. Functional Outcomes of Sleep Questionnaire (FOSQ)

    Effect of CBT on Self-reported Everyday Activities, Mood and Quality of Life. Functional Outcomes of Sleep Questionnaire (FOSQ) total scores range from 5 to 20. Lower values indicate higher functioning across different functional areas (e.g., less interference of fatigue on work functioning or on relationships).

    The investigators hypothesize that after initiating CPAP treatment, Veterans in the CBT-OSA group will report more improvement in the ease of performing everyday activities compared to that reported by those in the Education group.

    Measured: 1 year

  2. California Verbal Learning Test, Second Edition (CVLT-II)

    Effect of CBT on Cognitive Outcomes. California Verbal Learning Test-II Long Delay Free Recall (CVLT-II LD FC) scores range from 0 to 16. Higher raw scores indicate more items retained and better memory performance.

    The investigators hypothesize that after initiating CPAP treatment, the CBT-OSA group will have better cognitive outcomes than the Education group over time. The California Verbal Learning Test-II, Delayed Recall Score is the cognitive outcome measure.

    Measured: 1 year

  3. PTSD Checklist for DSM-5 (PCL-5)

    Effect of CBT on PTSD. PTSD Checklist for DSM-5 (PCL-5) total scores range from 0 to 80. For the PCL-5, higher values indicate higher levels of current PTSD symptoms, thus a higher level of current PTSD severity.

    The investigators hypothesize that after initiating CPAP treatment, the CBT-OSA group will have fewer PTSD symptoms than the Education group over time. The PTSD Checklist for DSM-5 (PCL-5) will be the PTSD outcome measure.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2015 (estimated)
  2. Study start1 Jan 2017
  3. Primary completion30 Sep 2022
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02641496
Sponsor's protocol ID
D1799-R
Status last verified
Apr 2024
First submitted
22 Dec 2015
Last updated
29 Jul 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CBT-OSA and Sleep Education in people with Obstructive Sleep Apnea and PTSD, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in Minutes of "mask-on" Positive Airway Pressure (PAP) Machine Usage Per Night (time frame: Treatment 1 to Treatment 4 (approximately first 30 days of treatment) and Last 30 Days of 1 Year Study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.

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