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Reducing the Burden of Chronic Conditions on Patients, Families, and the Healthcare System Comparison of Sleep Apnea Assessment Strategies to Maximize TBI Rehabilitation Participation and Outcome Clinicaltrial.gov Registration Number: NCT03033901 Risa Nakase-Richardson, Ph.D., FACRM Mental Health and Behavioral Sciences, Defense and Veterans Brain Injury Center, James A Haley Veterans Hospital, Tampa, FL Professor, Morsani College of Medicine, University of South Florida, Tampa, FL Acknowledgements This work is supported by the Patient Centered Outcomes Research Institute PCORI – CER-1511-33005 Defense Health Agency’s Defense and Veterans Brain Injury Center and Subcontractor General Dynamics Health Solution DVBIC-W91YTZ-13-C-0015 National Institute on Disability, Independent Living, and Rehabilitation Research TBI Model Systems Grant # 90DPTB00070, 90DPTB0013-01-00, 90DPTB0008, 90DPT8000402, 90DP0084 This material is the result of work supported with resources and the use of facilities at the James A Haley Veterans Hospital, Tampa Florida, and the National Institute on Disability Rehabilitation and Research TBI Model Systems Programs Disclaimers/Disclosures • Disclaimer: – The statements presented in this publication are solely the responsibility of the author(s) and not necessarily represent the views of the Patient-Centered Outcomes Research Institute® (PCORI®), its Board of Governors or Methodology Committee – Contents may not represent the views of the Department of Veterans Affairs or the United States Government • Financial Disclosure: – None Retired Naval Commander Joseph Coulter Mrs Jill Coulter Journey From A Severe TBI Joseph “Pepper” Coulter U.S Navy - 20 Years Severe TBI • Fell feet from ladder while trimming trees • Disorder of Consciousness 36 weeks post-injury Hospitalized for 11 Weeks Today – years later • Strengths – Involved with the TBI community – Rediscovered talent for wood working – I’ve relearned how to • Walk • Speak • Formulate Thoughts • Challenges – Neuro-fatigue / Sleep Health • Motivation for Treatment – Non-fluent aphasia (trouble with fluently speaking) – worsens when tired There is no cure for traumatic brain injury (TBI) Full Recovery Rehab Rehab Does comorbidity slow the pace of recovery and potentiate early decline? Why Sleep Apnea? • The Clinical Dilemma – Assessment for specific sleep disorders is critical to the delivery of evidence based treatments – Poor characterization of the sleep disturbance can lead to delivery of the wrong treatment – Little guidance exists to inform clinicians’ (TBI physicians, sleep medicine) approach to assessment of specific sleep disorders in the acute rehabilitation setting for moderate to severe TBI • Stakeholder Input – Clinicians/Scientists • GBC Think Tank Meeting-Prioritized earlier diagnosis of OSA – Patients/Families (focus groups/surveys) • “[I] can’t imagine another issue more important than helping TBI persons regain the ability to regulate their normal sleep patterns.” – Non-TBI Stakeholder Input (Agency for Healthcare Research and Quality) • Future Research Needs Papers 11&12 - Sleep Apnea Diagnosis & Treatment Study Aims Comparative effectiveness: Aim Screening: Sleep apnea screening tools • StopBang • Berlin Questionnaire • Multi-Apnea Prediction Index • Objective Markers (exploratory) Aim Diagnosis: Non-inferiority of Level to Level Sleep Study • Level (portable; more accessible) to • Level (gold standard; less accessible, more costly) Criterion Standard: Level Polysomnography Total AHI >15 Developed Objective Sleep Measurement Network in TBI Model Systems Infrastructure Comparison of Sleep Apnea Assessment Strategies to Maximize TBI Rehabilitation Participation and Outcome (C-SAS) Clinical Trial: NCT03033901 PI: Risa Nakase-Richardson, Ph.D., FACRM, FNAN Sleep Research Network Moss Rehabilitation & Research Institute Philadelphia, PA University of Washington Seattle, WA Ohio State University Columbus, OH Craig Hospital Denver, CO National Data Center Staff are Tampa VA WOC Baylor Scott & White & U Texas Southwestern Dallas, TX James A Haley Veterans Hospital Tampa, FL Centralized Scoring Center Aim – Screening Nakase-Richardson R, Schwartz DJ, Drasher-Phillips L, Ketchum JM, Calero K, Dahdah MN, Monden KR, Bell K, Magalang U, Hoffman J, Whyte J, Bogner J, Zeitzer JM Comparative Effectiveness of Sleep Apnea Screening Instruments During Inpatient Rehabilitation Following Moderate to Severe TBI Archives of Physical Medicine and Rehabilitation, Accepted pending Minor Revision Aim 2: Diagnostic PSG Comparison (Non-Inferiority) Aim 2: Results 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 and evaluation of non-inferiority across types of sleep studies to detect sleep apnea in moderate to severe traumatic brain injury neurorehabilitation admissions Under Review, Submitted September 17, 2019 AHI ≥ AHI ≥ 15 AHI ≥ 30 SE 0.833 0.889 0.821 94.9% LCL 0.764 0.793 0.665 Sensitivity SP 0.906 0.951 0.977 (Inferior) 94.5% LCL 0.807 0.901 0.943 Specificity Non-Inferior * No * No * No (Non-Inferior) AHI ≥ AHI ≥ 15 AHI ≥ 30 0.6 0.7 0.8 0.9 0.4 0.5 0.6 0.7 0.8 0.9 Impact • First study to identify screening and diagnostic methods for OSA in the TBI inpatient rehabilitation setting • Improved access to OSA diagnosis and treatment for moderate to severe TBI while hospitalized • Early identification and treatment of sleep apnea may improve TBI outcomes “I see the significant effects of sleep disorders on my patient’s ability to effectively participate and benefit from cognitive therapy Kathryn Kieffer, SpeechLanguage Pathologist, Clinician Stakeholder Engagement • Operational Partners (Administration) – Rehabilitation / Epidemiology – Department of Defense • Stakeholders – Clinicians (6 specialties) – Patients and Caregivers – Academia – Industry “I have also been able to help shape the dissemination and potential implementation plan following completion of the study Stakeholder early involvement will result in enhanced implementation and use of study findings ultimately resulting in improved quality of life for Veterans with TBI.” Dr Joel Scholten, National Director, PMRS, VHA “It is an honor and privilege to be part of this PCORI research project… Grateful that my voice is heard, encouraged and appreciated, allowing the team to see the process from the patient/caregivers point of view.” Jill Coulter, Caregiver, Tampa, FL Thanks to our sleep deprived RAs! Risa.Richardson@va.gov Collaborators Sleep Medicine- University of South Florida & Tampa VAMC Daniel J Schwartz, M.D Karel Calero, M.D Carlos Diez-Sien, RSPGT Leah Drasher-Phillips, M.P.H Danielle O’Conner, MPH Emily Noyes, M.S Physical Medicine and Rehabilitation, Tampa VAMC Steven Scott, D.O Sleep Physiology, Stanford University & Palo Alto VAMC Jamie Zeitzer, Ph.D Baylor Scott & White Rehabilitation, Dallas, TX Marie DahDah, Ph.D University of Texas Southwestern, Dallas, TX Kathleen Bell, M.D Moss Rehabilitation and Research Institute, Philadelphia, PA John Whyte, M.D., Ph.D Thomas Watanable, M.D University of Washington, Seattle, WA Jeanne Hoffman, Ph.D Jesse Fann, M.D Craig Hospital, Denver, CO Cindy Harrison-Felix, Ph.D Kim Monden, Ph.D Jesse Ketchum, Ph.D Ohio State University, Columbus, OH Jennifer Bogner, Ph.D Ulysses Magalong, M.D Knowledge Translation for Clinicians https://issuu.com/braininjuryprofessional/docs/bip _february_2018?e=1121786/58553316 • Nakase-Richardson R Improving the recognition and treatment of sleep disorders in neurorehabilitation • Nakase-Richardson R, Schwartz DJ Sleep Apnea and Traumatic Brain Injury • Dahdah MN, Bell K, Lequerica AH, et al Effectiveness of Cognitive Behavioral Therapy for Treating Insomnia in Healthy Individuals and those with Brain Injury • Zeitzer JM, Watson EM, Holcomb E Circadian Rhythms: Disruptions and Treatments in Acute Traumatic Brain Injury • Monden KR, Gerber D, Newman J et al Sleep Hygiene: A Novel, Nonpharmacological Approach to Treating Sleep-Wake Cycle Disturbance after Moderate to Severe Brain Injury on an Inpatient Rehabilitation Unit • Nallu S Recommended Sleep Duration for Adults and Children: An American Academy of Sleep Medicine and Sleep Research Society Consensus Statement • Nakase-Richardson R Interview with An Expert: Dr Mark Aloia
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