Mode
Text Size
Log in / Sign up
N/A Completed N=17 Other

Feasibility of Improving Sleep Apnea Treatment Adherence After Brain Injury

Sleep Apnea, Obstructive · Brain Injuries, Traumatic
Source: ClinicalTrials.gov NCT04221009 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Narrative Evaluation of Intervention Interview (Post-intervention Qualitative Interview) — 4 Themes

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Narrative Evaluation of Intervention Interview (Post-intervention Qualitative Interview)
4
SECONDARY
Epworth Sleepiness Scale
11.0
SECONDARY
Fatigue Severity Scale
36.4
SECONDARY
Functional Outcomes of Sleep Questionnaire
14.7

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04221009). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search