This is a two-arm, parallel-group randomized controlled feasibility trial involving 40 community-dwelling adults with chronic stroke and ongoing sleep or circadian difficulties. Participants will be randomly assigned in a 1:1 ratio to either an individualized behavioral sleep intervention or an attention-matched health education program. Before randomization, participants will complete questionnaires assessing sleep and related health outcomes, maintain a sleep diary, and wear a wrist-worn activity monitor for seven days. Participants will then attend six weekly, individual, face-to-face sessions lasting approximately one hour each. The behavioral sleep intervention will provide individualized education and behavioral strategies to support sleep and daily sleep-wake functioning following stroke. The comparison program will provide education about stroke, sleep, and general health. The two programs will be matched in session frequency and duration. Following the six-week program, participants will repeat the questionnaires, sleep diary, and seven-day wrist-monitoring assessment. Participants will also provide feedback about their experiences with the study and program. The trial will evaluate recruitment, retention, attendance, intervention delivery, acceptability, fidelity, and safety. Preliminary changes in sleep and sleep-wake outcomes will also be examined.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
A six-week, individual, face-to-face behavioral program designed to address sleep and sleep-wake difficulties following stroke. Participants attend one approximately 60-minute session per week. The program provides education and individualized behavioral strategies based on each participant's sleep-related needs.
A six-week education program providing general information about stroke, sleep, and health.
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Recruitment Rate
Number of participants enrolled divided by the number of months of active recruitment.
Time frame: From the start of recruitment through completion of recruitment
Participant Retention
Number and proportion of enrolled participants who complete the study.
Time frame: From enrollment through completion of the 3-month follow-up.
Intervention Attendance
Number and proportion of the six scheduled intervention sessions attended by participants.
Time frame: Up to 6 weeks.
Acceptability
Acceptability will be assessed using the 4-item Acceptability of Intervention Measure. Items are rated from 1 to 5, producing a total score from 4 to 20, with higher scores indicating greater acceptability.
Time frame: Immediately after the 6-week intervention.
Number of Adverse Events
Number of any adverse events during the study.
Time frame: From enrollment through the 3-month follow-up, up to approximately 5 months.
Fidelity
Proportion of sampled ISleepFAST intervention components delivered as intended, based on review of recorded sessions using an intervention fidelity checklist.
Time frame: Throughout the 6-week intervention period.
Change in Sleep and Circadian Sleep-Wake Functioning
Sleep and circadian sleep-wake functioning will be assessed using seven-day wrist actigraphy, sleep diaries, and standardized questionnaires. Prespecified measures will include sleep timing, sleep duration, sleep efficiency, sleep regularity, and rest-activity rhythm characteristics.
Time frame: Baseline, immediately after the intervention, 3-month follow-up
Change in Sleep Disturbance
Sleep disturbance will be assessed using the 8-item Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form. It assesses perceived sleep quality, depth, adequacy, satisfaction, and difficulties initiating and maintaining sleep. Higher scores indicate greater sleep disturbance.
Time frame: Baseline, immediately after the 6-week intervention, and 3 months after the intervention.
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