Study Protocol: Sleep Effects on Poststroke Rehabilitation Study

Abstract

Background: A range of sleep disturbances and disorders are problematic in people after stroke; they interfere with recovery of function during poststroke rehabilitation. However, studies to date have focused primarily on the effects of one sleep disorder-obstructive sleep apnea (OSA)-on stroke recovery.

Objectives: The study protocol for the SLEep Effects on Poststroke Rehabilitation (SLEEPR) Study is presented with aims of characterizing proportion of non-OSA sleep disorders in the first 90 days after stroke, evaluating the effect of non-OSA sleep disorders on poststroke recovery, and exploring the complex relationships between stroke, sleep, and recovery in the community setting.

Methods: SLEEPR is a prospective cohort observational study across multiple study sites following individuals from inpatient rehabilitation through 90 days poststroke, with three measurement time points (inpatient rehabilitation; i.e., ~15 days poststroke, 60 days poststroke, and 90 days poststroke). Measures of sleep, function, activity, cognition, emotion, disability, and participation will be obtained for 200 people without OSA at the study's start through self-report, capacity assessments, and performance measures. Key measures of sleep include wrist actigraphy, sleep diaries, overnight oximetry, and several sleep disorders screening questionnaires (Insomnia Severity Index, Cambridge-Hopkins Restless Legs Questionnaire, Epworth Sleepiness Scale, and Sleep Disorders Screening Checklist). Key measures of function and capacity include the 10-meter walk test, Stroke Impact Scale, Barthel index, and modified Rankin scale. Key performance measures include leg accelerometry (e.g., steps/day, sedentary time, upright time, and sit-to-stand transitions) and community trips via GPS data and activity logs.

Discussion: The results of this study will contribute to understanding the complex interplay between non-OSA sleep disorders and poststroke rehabilitation; they provide insight regarding barriers to participation in the community and return to normal activities after stroke. Such results could lead to strategies for developing new stroke recovery interventions.

Trial registration: ClinicalTrials.gov NCT05012605.

Figure 1

SLEEPR Study Protocol