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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 : Recruiting
First Posted : January 27, 2017
Last Update Posted : May 2, 2018
Sponsor:
Collaborators:
Patient-Centered Outcomes Research Institute
Craig Hospital
Moss Rehabilitation Research Institute
University of Washington
Baylor Institute for Rehabilitation
Ohio State University
University of South Florida
Palo Alto Veterans Institute for Research
North Florida Foundation for Research and Education
Information provided by (Responsible Party):
James A. Haley Veterans Administration Hospital

Brief 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 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

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 259 participants
Observational Model: Cohort
Time Perspective: Prospective
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 : January 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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 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


Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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).

  2. 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).

  3. 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

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be TBI patients admitted to inpatient rehabilitation at an existing NIDILRR or VA funded TBI Model System Center who meet study inclusion and exclusion criteria.
Criteria

Inclusion Criteria:

  1. 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 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) PT, 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 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

  2. admission to an inpatient brain injury rehabilitation program;
  3. minimum age 16 years at civilian sites and 18 years at the VA site;
  4. Understands and provides informed consent to participate (or, if unable, healthcare proxy / legal guardian understands and provides informed consent for the patient);
  5. 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:

  1. persons less than 16 years old at civilian sites and less than 18 years old at VA site will not be included;
  2. pre-injury diagnosis of narcolepsy or persistent daytime somnolence as documented in patient's medical record and/or family report; and/or
  3. tracheostomy placed and decannulation or overnight capping of the tracheostomy not feasible during rehabilitation hospitalization.

Information from the National Library of Medicine

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


Contacts
Contact: Risa Richardson, PhD 813-972-2000 ext 5309 Risa.Richardson@va.gov
Contact: Leah Drasher-Phillips, MPH 813-972-2000 ext 1683 Leah.Drasher-Phillips@va.gov

Locations
United States, Colorado
Craig Hospital Recruiting
Englewood, Colorado, United States, 80113
Contact: Cynthia Harrison-Felix, PhD    303-789-8565    CHarrison-Felix@CraigHospital.org   
Principal Investigator: Don Gerber, PsyD         
Sub-Investigator: Kimberely Monden, PhD         
United States, Florida
James A. Haley Veterans' Hospital Recruiting
Tampa, Florida, United States, 33612
Contact: Risa Richardson, PhD    813-972-2000 ext 5309    Risa.Richardson@va.gov   
Contact: Leah Drasher-Phillips, MPH    813-972-2000 ext 1683    Leah.Drasher-Phillips@va.gov   
Principal Investigator: Risa Richardson, PhD         
Sub-Investigator: Daniel Schwartz, MD         
Sub-Investigator: Karel Calero, MD         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Jennifer Bogner, PhD    614-293-3830    bogner.1@osu.edu   
Principal Investigator: Jennifer Bogner, PhD         
Sub-Investigator: Ulysses Magalang, MD         
United States, Pennsylvania
Albert Einstein Healthcare Network/Moss Rehabilitation Hospital Recruiting
Elkins Park, Pennsylvania, United States, 19027
Contact: John Whyte, MD, PhD    215-663-6872    jwhyte@einstein.edu   
Principal Investigator: John Whyte, MD, PhD         
Sub-Investigator: Thomas Watanabe, MD         
United States, Texas
Baylor Institute for Rehabilitation Recruiting
Dallas, Texas, United States, 75246
Contact: Marie Dahdah, PhD    415-730-1177    Marie.Dahdah@BSWHealth.org   
Principal Investigator: Marie Dahdah, PhD         
Sub-Investigator: Kathleen Bell, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98104
Contact: Jeanne Hoffman, PhD    206-221-6511    JeanneH@uw.edu   
Contact: Leslie Kempthorne    206-543-0219    ette@uw.edu   
Principal Investigator: Jeanne Hoffman, PhD         
Sub-Investigator: Jesse Fann, MD         
Sponsors and Collaborators
James A. Haley Veterans Administration Hospital
Patient-Centered Outcomes Research Institute
Craig Hospital
Moss Rehabilitation Research Institute
University of Washington
Baylor Institute for Rehabilitation
Ohio State University
University of South Florida
Palo Alto Veterans Institute for Research
North Florida Foundation for Research and Education
Investigators
Principal Investigator: Risa Richardson, PhD James A. Haley Veterans' Hospital

Additional Information:
Publications:

Responsible Party: James A. Haley Veterans Administration Hospital
ClinicalTrials.gov Identifier: NCT03033901     History of Changes
Other Study ID Numbers: CER-1511-33005
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Final de-identified data sets underlying publications resulting from the proposed research will be available outside VA in electronic format, through email upon request, after results are published. Data sets will be available for collaborators and other investigators upon request prior to publication (expected time period: 30 days post request). The extent of the data will be de-identified aggregate data only.

Keywords provided by James A. Haley Veterans Administration Hospital:
Veterans
Comparative Effectiveness Research
Diagnosis

Additional relevant MeSH terms:
Apnea
Brain Injuries
Brain Injuries, Traumatic
Sleep Apnea Syndromes
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Central Nervous System Diseases
Nervous System Diseases
Dyssomnias