Comparison of Sleep Apnea Assessment Strategies to Maximize TBI Rehabilitation Participation and Outcome
Apnea, Sleep · Brain Injury, Traumatic
Bottom Line
View on ClinicalTrials.gov: NCT03033901 ↗Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Polysomnography - Level 1 and Level 3 (Device); Actigraphy monitoring (Device); Sleep Apnea Screening (Other)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- James A. Haley Veterans Administration Hospital
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea-Hypopnea Index (AHI) |
24.4 | — |
Summary
Eligibility Criteria
Inclusion Criteria
- Meet case definition for TBI:
(A). VA (for James A. Haley Veterans' Hospital): i. Persons fitting the definition of traumatic brain injury (TBI), defined as a traumatically induced structural brain injury, brain trauma, or damage to brain tissue, and/or physiological disruption of brain function as a result of an external mechanical force (also including acceleration/deceleration movement without direct external trauma to the head, a foreign body penetrating the brain, forces generated from events such as a blast or explosion, or other force) as evidenced by self-reported or medically documented (physical examination or mental status examination) new onset or worsening of at least one of the following clinical signs immediately following the event: (a) a period of loss of or a decreased level of consciousness; (b) alteration in mental state at the time of the injury (confusion, disorientation, slowed thinking); (c) loss of memory for events immediately before or after the injury; (d) posttraumatic amnesia (PTA); (d)neurological deficits (weakness, imbalance, change in vision, praxis, paresis/plegia, sensory loss, aphasia, etc.) that may or may not be transient; or (e) intracranial lesion. ii. Age 18 or older at the time of index TBI. iii. Admitted to one of the five designated VA Polytrauma Rehabilitation Centers (PRCs) for comprehensive rehabilitation with the presenting diagnoses of TBI. Comprehensive rehabilitation must occur in the PRC and meet the following criteria: (a) Medical and rehabilitation care are supervised on a regular basis by a physician affiliated with the PRC; (b) 24-hour nursing care is provided to the patient; (c) Physical Therapy (PT), Occupational Therapy (OT), Speech, Rehabilitation Psychology, Neuropsychology, and/or family support/education are provided in an integrated team approach with the expectation of further gain; (d) Operates in a manner consistent with Commission on Accreditation of Rehabilitation Facilities (CARF) standards for brain injury inpatient rehabilitation and/or Medicare requirements for inpatient rehabilitation.
OR
(B). Civilian (for civilian sites): Damage to brain tissue caused by an external mechanical force, alteration of consciousness > 24 hours, or loss of consciousness >30 minutes, or Glasgow Coma Scale (GCS) score in the Emergency Department of3-12, or intracranial abnormalities on imaging regardless of GCS;
AND
- admission to an inpatient brain injury rehabilitation program;
- minimum age 16 years at civilian sites and 18 years at the VA site;
- Understands and provides informed consent to participate (or, if unable, healthcare proxy / legal guardian understands and provides informed consent for the patient);
- sleep duration > 2 hours/night.
Although not specifically targeted, pregnant women and people with intellectual developmental disorders or prior psychiatric histories meeting the above inclusion/exclusion criteria can be enrolled in this study. Individuals with known history of sleep apnea will be eligible for the study and apnea status will be reconfirmed with new diagnostic study.
Exclusion Criteria
- persons less than 16 years old at civilian sites and less than 18 years old at VA site will not be included;
- pre-injury diagnosis of narcolepsy or persistent daytime somnolence as documented in patient's medical record and/or family report; and/or
- tracheostomy placed and decannulation or overnight capping of the tracheostomy not feasible during rehabilitation hospitalization.
Data sourced from ClinicalTrials.gov (NCT03033901). 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.