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Feasibility of Improving Sleep Apnea Treatment Adherence After Brain Injury (FISATABI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04221009
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : August 24, 2020
Sponsor:
Collaborator:
James A. Haley Veterans Administration Hospital
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

Background: Obstructive sleep apnea (OSA) is a sleep disorder that commonly occurs in Veterans with moderate-to-severe traumatic brain injury (TBI). Untreated OSA increases risk of poor health outcomes including cognitive impairment, declining mental health, poor physical health, and premature mortality. Positive airway pressure (PAP) is the frontline treatment for OSA that effectively reduces the many negative health consequences of the disease. However, adherence to PAP is required to reap the therapeutic benefit. 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 part of the standard of care for OSA treatment with PAP, but on its own is insufficient for improving PAP 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 increase PAP use and improve PAP adherence in persons without TBI. 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 4-session 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 will test the feasibility and acceptability of delivering the PAP adherence intervention. Study Aim 2 will evaluate the feasibility of outcome and process measures. To date, no treatment exists to ameliorate the adverse consequences of moderate-to-severe TBI. OSA is a treatable health condition that commonly co-occurs with TBI, which is a leading cause of long-term disability.

Method: In this study, 19 Veterans will be 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) will be 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. Adherence will be measured via objective data from hospital software which monitors PAP use.


Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Brain Injuries, Traumatic Behavioral: MI and CBT 4-session manualized intervention Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Improving Sleep Apnea Treatment Adherence After Brain Injury: A Feasibility Study
Actual Study Start Date : August 3, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Intervention (single arm)
This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.
Behavioral: MI and CBT 4-session manualized intervention
This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.




Primary Outcome Measures :
  1. Narrative Evaluation of Intervention Interview [ Time Frame: Post-intervention (roughly 4-8 weeks after enrollment) ]
    The Narrative Evaluation of Intervention Interview is a 16-item semi-structured interview that elicits participant feedback about an intervention. Data are text/qualitative.


Secondary Outcome Measures :
  1. Epworth Sleepiness Scale [ Time Frame: After each intervention session (roughly 1-4 weeks following the first session) ]
    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

  2. Fatigue Severity Scale [ Time Frame: After each intervention session (roughly 1-4 weeks following the first session) ]
    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.

  3. Functional Outcomes of Sleep Questionnaire [ Time Frame: After each intervention session (roughly 1-4 weeks following the first session) ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • moderate-to-severe TBI consistent
  • diagnosed with OSA and prescribed PAP therapy
  • nonadherent to PAP treatment
  • are able to consent.

Exclusion Criteria:

  • mild only TBI
  • no TBI
  • no OSA
  • not prescribed PAP therapy
  • adherent to PAP therapy (6) unable to provide consent on own behalf

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04221009


Contacts
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Contact: Marc A Silva, PhD (813) 972-2000 ext 5613 marc.silva1@va.gov
Contact: Leah M Drasher-Phillips, MPH (813) 558-7670 Leah.Drasher-Phillips@va.gov

Locations
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United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL Recruiting
Tampa, Florida, United States, 33612
Contact: Marc A Silva, PhD    813-972-2000 ext 5613    marc.silva1@va.gov   
Contact: Leah M Drasher-Phillips, MPH    (813) 558-7670    Leah.Drasher-Phillips@va.gov   
Principal Investigator: Marc A Silva, PhD         
Sponsors and Collaborators
VA Office of Research and Development
James A. Haley Veterans Administration Hospital
Investigators
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Principal Investigator: Marc A Silva, PhD James A. Haley Veterans' Hospital, Tampa, FL
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Study Protocol  [PDF] October 24, 2019

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04221009    
Other Study ID Numbers: N3303-P
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: Will be available starting twelve months following publication of study findings.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Feasibility Studies
Continuous Positive Airway Pressure
Psychotherapy, Brief
Cognitive Behavioral Therapy
Motivational Interviewing
Sleep Apnea, Obstructive
Brain Injuries, Traumatic
Veterans
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System