Sleep, Stroke
Conditions
Keywords
Stroke, Sleep, Circadian Rhythm
Brief summary
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.
Interventions
BEHAVIORALISleepFAST
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.
BEHAVIORALStroke and Sleep Health Education
A six-week education program providing general information about stroke, sleep, and health.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>6 months from last stroke 2. aged ≥18 years 3. Cantonese language fluency 4. ≥1 self-reported sleep or circadian problem(s) for 3 months: ≥30 min to get to sleep on ≥3 nights per week, waking in the middle of night ≥30 min on ≥3 nights per week, \<6-hr sleep per night or ≥9-hr sleep per 24 hour period on ≥3 nights per week, ≥1.09 hours of variability in sleep-wake schedule across one week, and/or bedtime after 2:00 a.m. on ≥3 nights per week 5. adequate opportunities for sleep.
Exclusion criteria
1. presence of an active and progressive physical or neurocognitive illness or substance abuse making participation infeasible 2. past or current involvement in psychological treatment for sleep issues 3. night shift work 4. pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | From the start of recruitment through completion of recruitment | Number of participants enrolled divided by the number of months of active recruitment. |
| Participant Retention | From enrollment through completion of the 3-month follow-up. | Number and proportion of enrolled participants who complete the study. |
| Intervention Attendance | Up to 6 weeks. | Number and proportion of the six scheduled intervention sessions attended by participants. |
| Acceptability | Immediately after the 6-week intervention. | 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. |
| Number of Adverse Events | From enrollment through the 3-month follow-up, up to approximately 5 months. | Number of any adverse events during the study. |
| Fidelity | Throughout the 6-week intervention period. | Proportion of sampled ISleepFAST intervention components delivered as intended, based on review of recorded sessions using an intervention fidelity checklist. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep and Circadian Sleep-Wake Functioning | Baseline, immediately after the intervention, 3-month follow-up | 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. |
| Change in Sleep Disturbance | Baseline, immediately after the 6-week intervention, and 3 months after the intervention. | 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. |
Countries
Hong Kong
Contacts
CONTACTStephen Lau
Outcome results
None listed