Comparison of Sleep Apnea Assessment Strategies to Maximize TBI Rehabilitation Participation and Outcome

NCT03033901 | Completed Results

• 1 other identifier: CER-1511-33005
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 6

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 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 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 Department of Health and Human Services and Veterans Affairs (VA).

Conditions

Apnea, Sleep; Brain Injury, Traumatic

Keywords

Veterans; Comparative Effectiveness Research; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea Index (AHI)

  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.

  During inpatient brain injury rehabilitation, which can occur on average (median) up to 37 days post-traumatic brain injury (TBI) in civilian settings and 132 days in Veterans Affairs (VA) settings.

Other Outcomes (4)

• STOPBang Sleep Apnea Risk

  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.

• Berlin Sleep Apnea Risk

  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.

• Actigraphy

  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.

Interventions

Polysomnography - Level 1 and Level 3 DEVICE

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.

Also known as: Philips Respironics Alice 6 Lab Diagnostic System, Nox T3

Actigraphy monitoring DEVICE

Participants will undergo actigraphy monitoring to assess habitual sleep duration to determine readiness for polysomnography and examine trajectory and duration of sleep.

Also known as: Philips Respironics Airway (AW) Spectrum Plus Actiwatch

Sleep Apnea Screening OTHER

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.

Also known as: Berlin Questionnaire, STOPBang Questionnaire, Multivariate Apnea Prediction Index

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• James A. Haley Veterans Administration Hospital: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Craig Hospital: collaborator
• Moss Rehabilitation Research Institute: collaborator
• University of Washington: collaborator
• Baylor Institute for Rehabilitation: collaborator
• Ohio State University: collaborator
• University of South Florida: collaborator
• Palo Alto Veterans Institute for Research: collaborator
• North Florida Foundation for Research and Education: collaborator

Study Sites (6)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

James A. Haley Veterans' Hospital

Tampa, Florida, 33612, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Albert Einstein Healthcare Network/Moss Rehabilitation Hospital

Elkins Park, Pennsylvania, 19027, United States

Location

Baylor Institute for Rehabilitation

Dallas, Texas, 75246, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (16)

• Holcomb EM, Schwartz DJ, McCarthy M, Thomas B, Barnett SD, Nakase-Richardson R. Incidence, Characterization, and Predictors of Sleep Apnea in Consecutive Brain Injury Rehabilitation Admissions. J Head Trauma Rehabil. 2016 Mar-Apr;31(2):82-100. doi: 10.1097/HTR.0000000000000230.

  PMID: 26959663 BACKGROUND

• Kamper JE, Garofano J, Schwartz DJ, Silva MA, Zeitzer J, Modarres M, Barnett SD, Nakase-Richardson R. Concordance of Actigraphy With Polysomnography in Traumatic Brain Injury Neurorehabilitation Admissions. J Head Trauma Rehabil. 2016 Mar-Apr;31(2):117-25. doi: 10.1097/HTR.0000000000000215.

  PMID: 26959665 BACKGROUND

• Towns SJ, Zeitzer J, Kamper J, Holcomb E, Silva MA, Schwartz DJ, Nakase-Richardson R. Implementation of Actigraphy in Acute Traumatic Brain Injury (TBI) Neurorehabilitation Admissions: A Veterans Administration TBI Model Systems Feasibility Study. PM R. 2016 Nov;8(11):1046-1054. doi: 10.1016/j.pmrj.2016.04.005. Epub 2016 May 10.

  PMID: 27178377 BACKGROUND

• Nakase-Richardson R. Improving the Significance and Direction of Sleep Management in Traumatic Brain Injury. J Head Trauma Rehabil. 2016 Mar-Apr;31(2):79-81. doi: 10.1097/HTR.0000000000000235. No abstract available.

  PMID: 26959662 BACKGROUND

• Holcomb EM, Towns S, Kamper JE, Barnett SD, Sherer M, Evans C, Nakase-Richardson R. The Relationship Between Sleep-Wake Cycle Disturbance and Trajectory of Cognitive Recovery During Acute Traumatic Brain Injury. J Head Trauma Rehabil. 2016 Mar-Apr;31(2):108-16. doi: 10.1097/HTR.0000000000000206.

  PMID: 26709584 BACKGROUND

• Nakase-Richardson R, Sherer M, Barnett SD, Yablon SA, Evans CC, Kretzmer T, Schwartz DJ, Modarres M. Prospective evaluation of the nature, course, and impact of acute sleep abnormality after traumatic brain injury. Arch Phys Med Rehabil. 2013 May;94(5):875-82. doi: 10.1016/j.apmr.2013.01.001. Epub 2013 Jan 4.

  PMID: 23296143 BACKGROUND

• Silva MA, Nakase-Richardson R, Sherer M, Barnett SD, Evans CC, Yablon SA. Posttraumatic confusion predicts patient cooperation during traumatic brain injury rehabilitation. Am J Phys Med Rehabil. 2012 Oct;91(10):890-3. doi: 10.1097/PHM.0b013e31825a1648.

  PMID: 22660372 BACKGROUND

• Nakase-Thompson R, Sherer M, Yablon SA, Nick TG, Trzepacz PT. Acute confusion following traumatic brain injury. Brain Inj. 2004 Feb;18(2):131-42. doi: 10.1080/0269905031000149542.

  PMID: 14660226 BACKGROUND

• Nakase-Richardson R, Dahdah MN, Almeida E, Ricketti P, Silva MA, Calero K, Magalang U, Schwartz DJ. Concordance between current American Academy of Sleep Medicine and Centers for Medicare and Medicare scoring criteria for obstructive sleep apnea in hospitalized persons with traumatic brain injury: a VA TBI Model System study. J Clin Sleep Med. 2020 Jun 15;16(6):879-888. doi: 10.5664/jcsm.8352.

  PMID: 32043962 BACKGROUND

• Nakase-Richardson R, Schwartz DJ, Ketchum JM, Drasher-Phillips L, Dahdah MN, Monden KR, Bell K, Hoffman J, Whyte J, Bogner J, Calero K, Magalang U. Comparison of Diagnostic Sleep Studies in Hospitalized Neurorehabilitation Patients With Moderate to Severe Traumatic Brain Injury. Chest. 2020 Oct;158(4):1689-1700. doi: 10.1016/j.chest.2020.03.083. Epub 2020 May 6.

  PMID: 32387522 BACKGROUND

• Nakase-Richardson R, Hoffman JM, Magalang U, Almeida E, Schwartz DJ, Drasher-Phillips L, Ketchum JM, Whyte J, Bogner J, Dismuke-Greer CE. Cost-Benefit Analysis From the Payor's Perspective for Screening and Diagnosing Obstructive Sleep Apnea During Inpatient Rehabilitation for Moderate to Severe TBI. Arch Phys Med Rehabil. 2020 Sep;101(9):1497-1508. doi: 10.1016/j.apmr.2020.03.020. Epub 2020 May 4.

  PMID: 32376325 BACKGROUND

• Zeitzer JM, Hon F, Whyte J, Monden KR, Bogner J, Dahdah M, Wittine L, Bell KR, Nakase-Richardson R. Coherence Between Sleep Detection by Actigraphy and Polysomnography in a Multi-Center, Inpatient Cohort of Individuals with Traumatic Brain Injury. PM R. 2020 Dec;12(12):1205-1213. doi: 10.1002/pmrj.12353. Epub 2020 Mar 26.

  PMID: 32125095 BACKGROUND

• Martin AM, Pinto SM, Tang X, Hoffman JM, Wittine L, Walker WC, Schwartz DJ, Kane G, Takagishi SC, Nakase-Richardson R. Associations between early sleep-disordered breathing following moderate-to-severe traumatic brain injury and long-term chronic pain status: a Traumatic Brain Injury Model Systems study. J Clin Sleep Med. 2023 Jan 1;19(1):135-143. doi: 10.5664/jcsm.10278.

  PMID: 36591795 DERIVED

• Steward KA, Silva MA, Maduri P, Tang X, Wittine L, Dams-O'Connor K, Nakase-Richardson R. Obstructive sleep apnea is associated with worse cognitive outcomes in acute moderate-to-severe traumatic brain injury: A TBI Model Systems study. Sleep Med. 2022 Dec;100:454-461. doi: 10.1016/j.sleep.2022.09.012. Epub 2022 Oct 5.

  PMID: 36252414 DERIVED

• Martin AM, Almeida EJ, Starosta AJ, Hammond FM, Hoffman JM, Schwartz DJ, Fann JR, Bell KR, Nakase-Richardson R. The Impact of Opioid Medications on Sleep Architecture and Nocturnal Respiration During Acute Recovery From Moderate to Severe Traumatic Brain Injury: A TBI Model Systems Study. J Head Trauma Rehabil. 2021 Sep-Oct 01;36(5):374-387. doi: 10.1097/HTR.0000000000000727.

  PMID: 34489388 DERIVED

• Nakase-Richardson R, Schwartz DJ, Drasher-Phillips L, Ketchum JM, Calero K, Dahdah MN, Monden KR, Bell K, Magalang U, Hoffman JM, Whyte J, Bogner J, Zeitzer JM. Comparative Effectiveness of Sleep Apnea Screening Instruments During Inpatient Rehabilitation Following Moderate to Severe TBI. Arch Phys Med Rehabil. 2020 Feb;101(2):283-296. doi: 10.1016/j.apmr.2019.09.019. Epub 2019 Nov 6.

  PMID: 31705855 DERIVED

Related Links

• NIDILRR-funded TBI Model System website

MeSH Terms

Conditions

Sleep Apnea Syndromes; Brain Injuries, Traumatic; Disease

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The sample may not represent the full population of inpatient rehabilitation patients with TBI; Short lengths of stay impacted study participation; unclear if findings extend to chronic phases of TBI.

Results Point of Contact

• Title: Risa Richardson, PhD
• Organization: James A. Haley Veterans' Hospital

Risa.Richardson@va.gov

813-972-2000

Study Officials

• Risa Richardson, PhD

  James A. Haley Veterans' Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 27, 2017
• Study Start: May 1, 2017
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: March 29, 2023
• Results First Posted: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available upon request following publication of the primary aims. Data will be made available while the Institutional Review Board (IRB) protocol remains active.
• Access Criteria: Data requests will be reviewed by the Study PI and responded to within 120 days of request. Data requests will follow the TBI Model System External Request Standard Operating Procedure (SOP) which is available at www.tbindsc.org.

Locations

US (6)