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NCT03033901 · ClinicalTrials.gov registry record
Comparison of Sleep Apnea Assessment Strategies to Maximize TBI Rehabilitation Participation and Outcome
A clinical trial, sponsored by James A. Haley Veterans Administration Hospital.
- Completed
- Registry status
- 345
- Enrollment target
NCT03033901: Completed study, sponsored by James A. Haley Veterans Administration Hospital.
NCT03033901 is a clinical trial that has completed, run by James A. Haley Veterans Administration Hospital. The registered enrollment target is 345 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03033901 has completed, sponsored by James A. Haley Veterans Administration Hospital.
- COMPLETED
- Registry status
- 345 participants
- Enrollment target
Study Summary
Background: Sleep disorders, including sleep apnea, are common after traumatic brain injury and affect recovery and negatively influence participation in rehabilitation. Sleep apnea is a breathing problem while persons sleep and causes further brain damage and problems with thinking, daily functioning, and overall health. Earlier diagnosis and treatment is important for traumatic brain injury (TBI) survivors to maximize the recovery process. There is little information that guides TBI doctors on how to identify sleep apnea during inpatient TBI rehabilitation, a phase in which people experience the potential for a rapid pace of improvement. The Agency for Healthcare Research has highlighted gaps in best methods for identifying sleep apnea and separately in helping consumers with TBI rehabilitation choices. Partnering with survivors, caregivers, and administrators, investigators developed this study to compare sleep apnea screening and diagnostic tools in TBI rehabilitation settings. This information will provide clinicians, providers, and patients with the best information for early identification of sleep apnea to remove negative influence on the pace of recovery in early phases after TBI. The Goal: Investigators will compare existing screening (Aim 1) and diagnostic tools (Aim 2) in TBI patients undergoing inpatient rehabilitation. For the second aim, investigators will determine if a more accessible diagnostic test is sufficient to diagnose sleep apnea compared to the traditional method used which is less accessible to consumers. If the more accessible test is good enough, this will increase recognition of this problem and increase patient access to earlier sleep apnea treatment. Stakeholders and Products. TBI survivors, caregivers, researchers, and policymakers working together on this study helped develop the study questions. Idea exchanges included ways to reach clinicians and TBI survivors/caregivers via existing educational programming and online tools for
Primary Outcome
A diagnosis of sleep apnea will be determined by overall apnea-hypopnea index (AHI) greater or equal to 5 and greater than or equal to 15 denoting different severity levels of disease.
Interventions
- DEVICE Polysomnography - Level 1 and Level 3
- DEVICE Actigraphy monitoring
- OTHER Sleep Apnea Screening
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2017-05-01 |
| Est. Completion | 2020-02-01 |
What the finished NCT03033901 record still lists
NCT03033901 is an observational study that tracks outcomes without assigning an intervention. The registered 345 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 3 interventions - of which Polysomnography - Level 1 and Level 3 is the first listed.
NCT03033901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03033901 about?
NCT03033901 is a clinical study titled "Comparison of Sleep Apnea Assessment Strategies to Maximize TBI Rehabilitation Participation and Outcome". Background: Sleep disorders, including sleep apnea, are common after traumatic brain injury and affect recovery and negatively influence participation in rehabilitation. Sleep apnea is a breathing problem while persons sleep and causes further brain damage and problems with thinking, daily functioni...
What is the current status of trial NCT03033901?
This trial is currently completed. The enrollment target is 345 participants. The study started on 2017-05-01. Estimated completion is 2020-02-01.
What interventions are being tested in trial NCT03033901?
The interventions under investigation include: Polysomnography - Level 1 and Level 3 (DEVICE), Actigraphy monitoring (DEVICE), Sleep Apnea Screening (OTHER).
Who is sponsoring clinical trial NCT03033901?
This trial is sponsored by James A. Haley Veterans Administration Hospital, which has 7 total clinical trials registered on ClinicalTrials.gov.
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