Sleep Apnea, ObstructiveFISATABINCT04221009
Feasibility of Improving Sleep Apnea Treatment Adherence After Brain Injury
A study testing MI and CBT 4-session manualized intervention in people with Sleep Apnea, Obstructive and Brain Injuries, Traumatic, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Background: Obstructive sleep apnea (OSA) is a sleep disorder common among Veterans with moderate-to-severe traumatic brain injury (TBI). Untreated OSA increases risk of poor health outcomes including cognitive impairment, declining mental and physical health, and premature mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Brain Injuries, Traumatic
- What is being tested?
- MI and CBT 4-session manualized intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 30 Jun 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate-to-severe TBI consistent
- diagnosed with OSA and prescribed PAP therapy
- nonadherent to PAP treatment
- are able to consent.
Who cannot join
- mild only TBI
- no TBI
- no OSA
- not prescribed PAP therapy
- adherent to PAP therapy (6) unable to provide consent on own behalf
Trial locations and contacts
1 site in 1 country.
United States1 site
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, 33612
About this study
Official title: Improving Sleep Apnea Treatment Adherence After Brain Injury: A Feasibility Study
Background: Obstructive sleep apnea (OSA) is a sleep disorder common among Veterans with moderate-to-severe traumatic brain injury (TBI). Untreated OSA increases risk of poor health outcomes including cognitive impairment, declining mental and physical health, and premature mortality. Positive airway pressure (PAP) is the frontline treatment for OSA that effectively reduces many negative health consequences of the disease. Unfortunately, PAP adherence is poor. A recent study showed that 68% of Veterans with moderate-to-severe TBI and OSA were nonadherent to PAP therapy. Psychoeducation is the standard of care for OSA treatment with PAP, but on its own is insufficient for improving adherence. Alternatives to the standard of care include evidence-based behavioral interventions such as Motivational Interviewing (MI) and Cognitive-Behavioral Therapy (CBT) which have been shown to improve PAP adherence in general sleep clinic samples. Unfortunately, these evidence-based interventions (designed for cognitively intact individuals) have not been adapted to address PAP adherence in persons with moderate-to-severe TBI, who often require cognitive accommodations. The goal of this study is to test the feasibility of a novel manualized intervention, designed with cognitive accommodations, and informed by MI and CBT, to address PAP adherence in Veterans with TBI and OSA.
Study Aims: Study Aim 1 tested the feasibility and acceptability of delivering the PAP adherence intervention. Study Aim 2 evaluated the feasibility of outcome and process measures.
Method: Veterans were recruited from inpatient and outpatient TBI and sleep clinics. Those meeting eligibility criteria (diagnosis of OSA and moderate-to-severe TBI; nonadherent to PAP, able to provide informed consent) were invited to participate in the 4-session intervention followed by a qualitative interview to inquire about intervention acceptability. Study measures (e.g., symptom severity, sleep quality of life), will be administered pre- and post-intervention.
Read the detailed description
Obstructive sleep apnea (OSA) is condition. The frontline treatment is Positive Airway Pressure (PAP) therapy. Adherence to PAP is essential to reap the therapeutic benefit of the treatment. Psychoeducation is part of the standard of care for the treatment of OSA, but on its own has been shown to be ineffective in improving PAP adherence. In persons without brain injury, alternatives to standard education, such as Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT), have been shown to improve PAP adherence. To date, no published studies have examined maximizing frontline PAP treatment for persons with brain injury. Therefore, the objective of this study is to develop and test the feasibility of a manualized intervention, derived from evidence-based MI and CBT, and adapted with cognitive accommodations, to maximize PAP success in Veterans with OSA and TBI-related burden.
This is a 2-year mixed methods study using quantitative and qualitative inquiry to determine the feasibility and acceptability of a novel 4-session PAP adherence intervention (Aim 1). Feasibility is the ease to which the intervention can be delivered (e.g., eligibility rates, recruitment rates), and acceptability is the extent to which persons receiving the intervention consider it appropriate (e.g., satisfaction ratings). Feasibility of process and the ultimate outcome measures (e.g., completeness, perceived value and burden) will also be examined (Aim 2).
Participants will be recruited from clinics within the James A. Haley Veterans' Hospital (JAHVH), a tertiary care facility and teaching hospital. Participants will be recruited from three clinical settings: (1) inpatient TBI neurorehabilitation; (2) outpatient TBI clinics; and (3) sleep medicine clinic. Inclusion criteria for this study are as follows: (1) moderate-to-severe TBI; (2) diagnosed with OSA and prescribed PAP therapy; (3) are nonadherent to PAP treatment; and (4) able to consent. The plan is to enroll 19 participants, because -- using a conservative 75% retention estimate - it is expected that 14 will complete the intervention, exceeding the minimum for data saturation.
Upon receipt of consent, the pre-intervention study measures will be administered. Veterans will be scheduled for four treatment sessions. After the final session, participants will complete post-intervention measures. The intervention will be delivered by a doctoral level psychologist. Two independent evaluators will listen to 20% of audio-recorded sessions and conduct intervention fidelity checks using a Fidelity Rating Checklist created for this study by the PI, and adapted from other rating MI and CBT fidelity forms. Of the recordings, 10% will be the same session to conduct interrater reliability checks of the ratings. Participants will be contacted within 15 business days of their last intervention session for the qualitative interview to gather information on acceptability of the intervention. The project manager/research assistant will download objective PAP adherence data from the PAP software program during study pre-screening and 30 days following the last intervention session, to permit evaluation of adherence.
Analysis will include examination of persons enrolled and retained versus study eligible, and reasons for non-enrollment. Attendance will be described. Acceptability will be examined via the post-intervention interview. Identification of themes will be generated from the analysis using a constant comparative approach. The qualitative team will independently read the data, assign labels and codes to data segments, and develop initial themes, then meet to develop consensus on initial themes and codes, revising them using an iterative process, confirming evidence and consider rival explanations that contrast with findings and conclusions. Study measures. Pre- and post-intervention measures which will be examined for completeness. Descriptive data will be presented (e.g., central tendency, variability, change scores, and effect sizes).
- Being tested
- MI and CBT 4-session manualized intervention
- Keywords
- Feasibility Studies, Continuous Positive Airway Pressure, Psychotherapy, Brief, Cognitive Behavioral Therapy, Motivational Interviewing, Sleep Apnea, Obstructive, Brain Injuries, Traumatic, Veterans
- Medical subject headings
- Sleep Apnea, Obstructive, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI and CBT 4-session manualized interventionBehavioural
This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (single arm) | Experimental | This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations. Receives: Behavioral: MI and CBT 4-session manualized intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narrative Evaluation of Intervention Interview (Post-intervention Qualitative Interview)
The Narrative Evaluation of Intervention Interview is a 16-item semi-structured interview that elicits participant feedback about an intervention. The data yielded by the NEII are qualitative, using qualitative thematic analysis. All 13 participants who completed the study also completed the NEII interview.
Measured: Post-intervention (up to 8 weeks after completion of the single arm intervention)
Secondary outcomes (3)
Epworth Sleepiness Scale
The Epworth Sleepiness Scale is an 8-item validated measure of daytime sleepiness. Respondents rate how likely they are to doze in eight situations, each on a scale from 0 to 3. Scores range from 0 to 24. Higher scores representing greater levels of excessive sleepiness
Measured: Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention
Fatigue Severity Scale
The Fatigue Severity Scale is a 9-item measure that is sensitive to change following OSA treatment. Respondents rate (on a scale from 1 to 7) the degree of fatigue symptoms experienced within the past 7 days. Total scores range from 9 to 63. Higher scores denote worse fatigue.
Measured: Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention
Functional Outcomes of Sleep Questionnaire
The Functional Outcomes of Sleep Questionnaire is a 30-item instrument that measures the impact of excessive sleepiness on quality of life in five domains. Items are rated from 1 to 4. Scores range from 1 to 120. Lower scores denote greater impact on quality of life.
Measured: Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start3 Aug 2020
- Primary completion31 Mar 2022
- Study completion30 Jun 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be asked to participate in four treatment sessions. The 4-session intervention is derived from evidence-based Motivational Interviewing and Cognitive Behavior Therapy. Participants will complete study measures pre- and post-intervention. Then, they will participate in a post-intervention interview to gather information of acceptability.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- James A. Haley Veterans Administration Hospital
- Responsible party
- Sponsor
- Investigators
- Marc A Silva, PhD, Principal investigator, James A. Haley Veterans' Hospital, Tampa, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221009
- Sponsor's protocol ID
- N3303-P
- Acronym
- FISATABI
- Status last verified
- Mar 2024
- First submitted
- 6 Jan 2020
- Last updated
- 8 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
Publications
Silva MA, Arriola NB, Radwan CK, Womble BM, Healey EA, Lee JM, Aloia MS, Nakase-Richardson R. Improving sleep apnea treatment adherence after traumatic brain injury: A nonrandomized feasibility study. Rehabil Psychol. 2022 Nov;67(4):461-473. doi: 10.1037/rep0000473.
PubMed 36355639
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep Apnea Treatment Adherence After Brain Injury: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04221009
- Acronym / sponsor ID
- FISATABI / N3303-P
- Keywords
- Feasibility Studies, Continuous Positive Airway Pressure, Psychotherapy, Brief, Cognitive Behavioral Therapy, Motivational Interviewing, Sleep Apnea, Obstructive, Brain Injuries, Traumatic, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- James A. Haley Veterans Administration Hospital
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Posted 8 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Obstructive sleep apnea (OSA) is a sleep disorder common among Veterans with moderate-to-severe traumatic brain injury (TBI). Untreated OSA increases risk of poor health outcomes including cognitive impairment, declining mental and physical health, and premature mortality. Positive airway pressure (PAP) is the frontline treatment for OSA that effectively reduces many negative health consequences of the disease. Unfortunately, PAP adherence is poor. A recent study showed that 68% of Veterans with moderate-to-severe TBI and OSA were nonadherent to PAP therapy. Psychoeducation is the standard of care for OSA treatment with PAP, but on its own is insufficient for improving adherence. Alternatives to the standard of care include evidence-based behavioral interventions such as Motivational Interviewing (MI) and Cognitive-Behavioral Therapy (CBT) which have been shown to improve PAP adherence in general sleep clinic samples. Unfortunately, these evidence-based interventions (designed for cognitively intact individuals) have not been adapted to address PAP adherence in persons with moderate-to-severe TBI, who often require cognitive accommodations. The goal of this study is to test the feasibility of a novel manualized intervention, designed with cognitive accommodations, and informed by MI and CBT, to address PAP adherence in Veterans with TBI and OSA.
Study Aims: Study Aim 1 tested the feasibility and acceptability of delivering the PAP adherence intervention. Study Aim 2 evaluated the feasibility of outcome and process measures.
Method: Veterans were recruited from inpatient and outpatient TBI and sleep clinics. Those meeting eligibility criteria (diagnosis of OSA and moderate-to-severe TBI; nonadherent to PAP, able to provide informed consent) were invited to participate in the 4-session intervention followed by a qualitative interview to inquire about intervention acceptability. Study measures (e.g., symptom severity, sleep quality of life), will be administered pre- and post-intervention.
Detailed description
Obstructive sleep apnea (OSA) is condition. The frontline treatment is Positive Airway Pressure (PAP) therapy. Adherence to PAP is essential to reap the therapeutic benefit of the treatment. Psychoeducation is part of the standard of care for the treatment of OSA, but on its own has been shown to be ineffective in improving PAP adherence. In persons without brain injury, alternatives to standard education, such as Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT), have been shown to improve PAP adherence. To date, no published studies have examined maximizing frontline PAP treatment for persons with brain injury. Therefore, the objective of this study is to develop and test the feasibility of a manualized intervention, derived from evidence-based MI and CBT, and adapted with cognitive accommodations, to maximize PAP success in Veterans with OSA and TBI-related burden.
This is a 2-year mixed methods study using quantitative and qualitative inquiry to determine the feasibility and acceptability of a novel 4-session PAP adherence intervention (Aim 1). Feasibility is the ease to which the intervention can be delivered (e.g., eligibility rates, recruitment rates), and acceptability is the extent to which persons receiving the intervention consider it appropriate (e.g., satisfaction ratings). Feasibility of process and the ultimate outcome measures (e.g., completeness, perceived value and burden) will also be examined (Aim 2).
Participants will be recruited from clinics within the James A. Haley Veterans' Hospital (JAHVH), a tertiary care facility and teaching hospital. Participants will be recruited from three clinical settings: (1) inpatient TBI neurorehabilitation; (2) outpatient TBI clinics; and (3) sleep medicine clinic. Inclusion criteria for this study are as follows: (1) moderate-to-severe TBI; (2) diagnosed with OSA and prescribed PAP therapy; (3) are nonadherent to PAP treatment; and (4) able to consent. The plan is to enroll 19 participants, because -- using a conservative 75% retention estimate - it is expected that 14 will complete the intervention, exceeding the minimum for data saturation.
Upon receipt of consent, the pre-intervention study measures will be administered. Veterans will be scheduled for four treatment sessions. After the final session, participants will complete post-intervention measures. The intervention will be delivered by a doctoral level psychologist. Two independent evaluators will listen to 20% of audio-recorded sessions and conduct intervention fidelity checks using a Fidelity Rating Checklist created for this study by the PI, and adapted from other rating MI and CBT fidelity forms. Of the recordings, 10% will be the same session to conduct interrater reliability checks of the ratings. Participants will be contacted within 15 business days of their last intervention session for the qualitative interview to gather information on acceptability of the intervention. The project manager/research assistant will download objective PAP adherence data from the PAP software program during study pre-screening and 30 days following the last intervention session, to permit evaluation of adherence.
Analysis will include examination of persons enrolled and retained versus study eligible, and reasons for non-enrollment. Attendance will be described. Acceptability will be examined via the post-intervention interview. Identification of themes will be generated from the analysis using a constant comparative approach. The qualitative team will independently read the data, assign labels and codes to data segments, and develop initial themes, then meet to develop consensus on initial themes and codes, revising them using an iterative process, confirming evidence and consider rival explanations that contrast with findings and conclusions. Study measures. Pre- and post-intervention measures which will be examined for completeness. Descriptive data will be presented (e.g., central tendency, variability, change scores, and effect sizes).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be asked to participate in four treatment sessions. The 4-session intervention is derived from evidence-based Motivational Interviewing and Cognitive Behavior Therapy. Participants will complete study measures pre- and post-intervention. Then, they will participate in a post-intervention interview to gather information of acceptability.
| Arm | Type | Receives |
|---|---|---|
| Intervention (single arm) | Experimental | Behavioral: MI and CBT 4-session manualized interventionThis is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- moderate-to-severe TBI consistent
- diagnosed with OSA and prescribed PAP therapy
- nonadherent to PAP treatment
- are able to consent.
Key exclusion criteria (5 listed)
- mild only TBI
- no TBI
- no OSA
- not prescribed PAP therapy
- adherent to PAP therapy (6) unable to provide consent on own behalf
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 |
|---|---|---|
| MI and CBT 4-session manualized interventionThis is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations. | Behavioural | Intervention (single arm) |
Primary outcome
Narrative Evaluation of Intervention Interview (Post-intervention Qualitative Interview)
Time frame: Post-intervention (up to 8 weeks after completion of the single arm intervention)
The Narrative Evaluation of Intervention Interview is a 16-item semi-structured interview that elicits participant feedback about an intervention. The data yielded by the NEII are qualitative, using qualitative thematic analysis. All 13 participants who completed the study also completed the NEII interview.
3 secondary outcomes
Epworth Sleepiness Scale
Time frame: Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention
Fatigue Severity Scale
Time frame: Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention
Functional Outcomes of Sleep Questionnaire
Time frame: Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36355639Silva MA, Arriola NB, Radwan CK, Womble BM, Healey EA, Lee JM, Aloia MS, Nakase-Richardson R. Improving sleep apnea treatment adherence after traumatic brain injury: A nonrandomized feasibility study. Rehabil Psychol. 2022 Nov;67(4):461-473. doi: 10.1037/rep0000473.
- Individual participant dataSharing planned: Yes. A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
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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.
Marc A Silva, PhD principal investigator
James A. Haley Veterans' Hospital, Tampa, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI and CBT 4-session manualized intervention in people with Sleep Apnea, Obstructive and Brain Injuries, Traumatic, 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 4 inclusion and 5 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 8 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 8 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?
Narrative Evaluation of Intervention Interview (Post-intervention Qualitative Interview) (time frame: Post-intervention (up to 8 weeks after completion of the single arm intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04221009, which also lists 1 linked publication.
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 8 Jul 2024.