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Feasibility of Improving Sleep Apnea Treatment Adherence After Brain Injury

NCT04221009 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-07-08

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • James A. Haley Veterans Administration Hospital

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Marc A Silva, PhD · James A. Haley Veterans' Hospital, Tampa, FL

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2022-03-31
Completion
2022-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04221009 on ClinicalTrials.gov