Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04221009 · ClinicalTrials.gov registry record · NA
Feasibility of Improving Sleep Apnea Treatment Adherence After Brain Injury
A NA study of Sleep Apnea, Obstructive and Brain Injuries, Traumatic, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT04221009 is a NA study of Sleep Apnea, Obstructive and Brain Injuries, Traumatic that has completed, run by VA Office of Research and Development. The registered enrollment target is 17 participants, below the 262-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04221009, a NA study of Sleep Apnea, Obstructive and Brain Injuries, Traumatic, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study 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 admin
Conditions Studied
Interventions
- BEHAVIORAL MI and CBT 4-session manualized intervention
Study Locations (1)
Florida
- James A. Haley Veterans' Hospital, Tampa, FL - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-08-03 |
| Est. Completion | 2022-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04221009
The ClinicalTrials.gov registry entry for NCT04221009 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 262-participant average among 45 other Sleep Apnea, Obstructive trials with a reported enrollment target (94% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Sleep Apnea, Obstructive appearing as the primary indexed condition, and to 1 intervention - of which MI and CBT 4-session manualized intervention is the first listed.
NCT04221009 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT04221009 about?
NCT04221009 is a clinical study titled "Feasibility of Improving Sleep Apnea Treatment Adherence After Brain Injury". 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 airwa...
What is the current status of trial NCT04221009?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2020-08-03. Estimated completion is 2022-06-30.
What conditions does trial NCT04221009 study?
This clinical trial studies the following conditions: Sleep Apnea, Obstructive, Brain Injuries, Traumatic.
What interventions are being tested in trial NCT04221009?
The interventions under investigation include: MI and CBT 4-session manualized intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT04221009?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04221009 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sleep Apnea, Obstructive
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
RECRUITING · NA
-
Home Apnea Testing in CHildren Trial
RECRUITING · NA
-
Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy
RECRUITING · NA
-
The REPOSE (Reach for Equity in Pediatric Sleep Evaluation) Navigation Intervention
RECRUITING · NA
-
Type 1 Diabetes and Obstructive Sleep Apnea
RECRUITING · NA
-
NPA-OSA Device Tolerability, Usability and Acclimation Clinical Study in Adult Obstructive Sleep Apnea (OSA) Patients
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.