Comparison of Sleep Apnea Assessment Strategies to Maximize TBI Rehabilitation Participation and Outcome (C-SAS)
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|ClinicalTrials.gov Identifier: NCT03033901|
Recruitment Status : Active, not recruiting
First Posted : January 27, 2017
Last Update Posted : March 27, 2019
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 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 consumers such as fact sheets and patient/caregiver-focused videos. Other traditional methods will include targeting professional magazines, conferences, and research journals that reach professionals working with TBI survivors and their families at the time of admission to rehabilitation and during the recovery process. This study will occur at rehabilitation hospitals around the country who enroll TBI survivors into a lifetime study called the TBI Model System funded by the Dept. of Health and Human Services and VA.
|Condition or disease||Intervention/treatment|
|Apnea, Sleep Brain Injury, Traumatic||Device: Polysomnography - Level 1 and Level 3 Device: Actigraphy monitoring Other: Sleep Apnea Screening|
|Study Type :||Observational|
|Estimated Enrollment :||259 participants|
|Official Title:||Comparison of Sleep Apnea Assessment Strategies to Maximize TBI Rehabilitation Participation and Outcome|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||March 1, 2020|
|Estimated Study Completion Date :||March 15, 2020|
- Device: Polysomnography - Level 1 and Level 3
Participants will undergo simultaneous administration of Level 1 and 3 polysomnography on the rehabilitation unit with study funded sleep technologist present to meet Level 1 standards.Other Names:
- Philips Respironics Alice 6 Lab Diagnostic System
- Nox T3
- Device: Actigraphy monitoring
Participants will undergo actigraphy monitoring to assess habitual sleep duration to determine readiness for polysomnography and examine trajectory and duration of sleep.Other Name: Philips Respironics Airway (AW) Spectrum Plus Actiwatch
- Other: Sleep Apnea Screening
Participants and their family member or proxy, and clinical staff will be asked to answer questions in order to complete the three standardized sleep apnea screening measures.Other Names:
- Berlin Questionnaire
- STOPBang Questionnaire
- Multivariate Apnea Prediction Index
- Apnea-Hypopnea Index (AHI) [ Time Frame: During inpatient brain injury rehabilitation, which can occur on average (median) up to 37 days post-TBI in civilian settings and 132 days in VA settings. ]A diagnosis of sleep apnea will be determined by overall apnea-hypopnea index (AHI) > 5 on Level 1 PSG and compared to Level 3 AHI.
- STOPBang sleep apnea risk [ Time Frame: During inpatient brain injury rehabilitation, which can occur on average (median) up to 37 days post-TBI in civilian settings and 132 days in VA settings. ]Sleep apnea screening measure. Risk based on responses to 8 items (2,low risk; 3-4, intermediate risk; >5, high risk).
- Berlin sleep apnea risk [ Time Frame: During inpatient brain injury rehabilitation, which can occur on average (median) up to 37 days post-TBI in civilian settings and 132 days in VA settings. ]Sleep apnea screening measure with 10-items. Risk stratification is based on number of items: no risk (no items endorsed), low (endorsement of 1 item) or high risk (endorsement of 2 or more items).
- Actigraphy [ Time Frame: During inpatient brain injury rehabilitation, which can occur on average (median) up to 37 days post-TBI in civilian settings and 132 days in VA settings. ]Philips brand Actiwatch Spectrum used to measure total sleep time
- Multivariate Apnea Prediction Index (MAPI) [ Time Frame: During inpatient brain injury rehabilitation, which can occur on average (median) up to 37 days post-TBI in civilian settings and 132 days in VA settings. ]Seven item measure denoting risk probability ranging from 0 to 100% based on items endorsed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033901
|United States, Colorado|
|Englewood, Colorado, United States, 80113|
|United States, Florida|
|James A. Haley Veterans' Hospital|
|Tampa, Florida, United States, 33612|
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|Albert Einstein Healthcare Network/Moss Rehabilitation Hospital|
|Elkins Park, Pennsylvania, United States, 19027|
|United States, Texas|
|Baylor Institute for Rehabilitation|
|Dallas, Texas, United States, 75246|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Risa Richardson, PhD||James A. Haley Veterans' Hospital|