Feasibility of Improving Sleep Apnea Treatment Adherence After Brain Injury

NCT04221009 | Completed Results

• 1 other identifier: N3303-P
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sleep Apnea, Obstructive; Brain Injuries, Traumatic

Keywords

Feasibility Studies; Continuous Positive Airway Pressure; Psychotherapy, Brief; Cognitive Behavioral Therapy; Motivational Interviewing; Sleep Apnea, Obstructive; Brain Injuries, Traumatic; Veterans

Outcome Measures

Primary Outcomes (1)

• 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.

  Post-intervention (up to 8 weeks after completion of the single arm intervention)

Secondary Outcomes (3)

• Epworth Sleepiness Scale

  Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention

• Fatigue Severity Scale

  Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention

• Functional Outcomes of Sleep Questionnaire

  Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention

Study Arms (1)

Intervention (single arm)

EXPERIMENTAL

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

Interventions

MI and CBT 4-session manualized intervention BEHAVIORAL

This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.

Intervention (single arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• James A. Haley Veterans Administration Hospital: collaborator

Study Sites (1)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• 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.

  PMID: 36355639 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Marc A Silva
• Organization: James A Haley Veterans' Hospital

marc.silva1@va.gov

813-972-2000

Study Officials

• Marc A Silva, PhD

  James A. Haley Veterans' Hospital, Tampa, FL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 7, 2020
• Study Start: August 3, 2020
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: July 8, 2024
• Results First Posted: July 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Will be available starting twelve months following publication of study findings.
• Access Criteria: Data are not publicly available. Information will be shared by contacting the study PI and upon institutional approval.

Locations

US (1)