BACKGROUND: Obstructive sleep apnea is prevalent during a time of critical neural repair following traumatic brain injury (TBI). The diagnostic utility of existing sleep studies is needed to inform clinical management during acute recovery from TBI.
RESEARCH QUESTION: This study aimed to evaluate the non-inferiority and diagnostic accuracy of a portable Level 3 sleep study relative to Level 1 polysomnography in hospitalized neurorehabilitation patients with traumatic brain injury.
STUDY DESIGN: and Methods: This is a prospective clinical trial conducted at six TBI Model System study sites between 05/2017 and 02/2019. Of 896 admissions, 449 were screened and eligible for the trial with 345 consented. Additional screening left 263 eligible for and completing simultaneous administration of both Level 1 and 3 sleep studies with final analyses completed on n=214 (median age=42; ED Glasgow Coma Scale=6; time to PSG=52 days).
RESULTS: Agreement was moderate to strong (weighted kappa = 0.78, 95% CI = 0.72, 0.83) with the misclassification commonly occurring with mild sleep apnea due to underestimation of AHI. A majority of those with moderate to severe sleep apnea were correctly classified (n=54/72). Non-inferiority was not demonstrated: the minimum tolerable specificity of 0.5 was achieved across all AHI cutoff scores (LCL range = 0.807-0.943) but the minimum tolerable sensitivity of 0.8 was not (LCL range = 0.665-0.764).
INTERPRETATION: While the non-inferiority of Level 3 portable diagnostic testing relative to Level 1 was not established, there was strong agreement across sleep apnea indices. A majority of those with moderate to severe sleep apnea were correctly identified; however, there was risk of misclassification with Level 3 sleep studies underestimating disease severity for those with moderate to severe AHI and disease presence for those with mild AHI during early TBI neurorehabilitation.
Bibliographical noteFunding Information:
FUNDING/SUPPORT: Research reported in this article was funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (CER-1511-33005). This research was sponsored by VHA Central Office VA TBI Model Systems Program of Research; Subcontract from General Dynamics Information Technology (W91YTZ-13-C-0015; HT0014-19-C-0004) from the Defense and Veterans Brain Injury Center and National Institute on Disability, Independent Living, and Rehabilitation Research (NSDC Grant # 90DPTB00070, #90DP0084, 90DPTB0013-01-00, 90DPTB0008, 90DPT80004-02). Clinicaltrial.gov Registration Number: NCT03033901.
- brain injury
- sleep apnea
- sleep-disordered breathing
PubMed: MeSH publication types
- Journal Article