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.
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
- Conditions the study is for
- Obstructive Sleep Apnea, PTSD, Posttraumatic Stress Disorder
- What is being tested?
- CBT-OSA and Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Obstructive Sleep Apnea, PTSD, Posttraumatic Stress Disorder
- 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 group | Role | What they receive |
|---|---|---|
| CBT-OSA | Experimental | CBT-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 Education | Active comparator | The 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.
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)
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
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
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.
- First posted29 Dec 2015 (estimated)
- Study start1 Jan 2017
- Primary completion30 Sep 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisa M. Kinoshita, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD
- ClinicalTrials.gov ID
- NCT02641496
- Acronym / sponsor ID
- D1799-R
- Conditions
- Obstructive Sleep Apnea, PTSD, Posttraumatic Stress Disorder
- Keywords
- Obstructive Sleep Apnea, PTSD, Posttraumatic Stress Disorder, Cognitive Behavioral Therapy, Continuous Positive Airway Pressure, CPAP, Cognition, Memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Posted 29 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-OSA | Experimental | Behavioral: CBT-OSACBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a CPAP machine. |
| Sleep Education | Active comparator | Behavioral: Sleep EducationThe Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-OSACBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a CPAP machine. | Behavioural | CBT-OSA |
| Sleep EducationThe Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene. | Behavioural | Sleep Education |
Primary outcome
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
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).
3 secondary outcomes
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: 1 year
California Verbal Learning Test, Second Edition (CVLT-II)
Time frame: 1 year
PTSD Checklist for DSM-5 (PCL-5)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M. Kinoshita, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
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.