Personalised Sleep and Circadian Intervention After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ISleepFAST, Stroke and Sleep Health Education.
- Who it may be relevant to
- Registry conditions: Stroke, Sleep. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility, Efficacy, and Patient Experience of a Personalised Transdiagnostic Intervention for Sleep and Circadian Dysfunction Following Stroke: a Mixed-method Randomised Controlled Feasibility Trial
Overview
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
- Behavioral ISleepFAST
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. - Behavioral Stroke and Sleep Health Education
A six-week education program providing general information about stroke, sleep, and health.
Primary outcome measures
- Recruitment Rate [Time frame: From the start of recruitment through completion of recruitment]
- Participant Retention [Time frame: From enrollment through completion of the 3-month follow-up.]
- Intervention Attendance [Time frame: Up to 6 weeks.]
- Acceptability [Time frame: Immediately after the 6-week intervention.]
- Number of Adverse Events [Time frame: From enrollment through the 3-month follow-up, up to approximately 5 months.]
- Fidelity [Time frame: Throughout the 6-week intervention period.]
Secondary outcome measures (2)
- Change in Sleep and Circadian Sleep-Wake Functioning [Time frame: Baseline, immediately after the intervention, 3-month follow-up]
- Change in Sleep Disturbance [Time frame: Baseline, immediately after the 6-week intervention, and 3 months after the intervention.]
Eligibility criteria
Inclusion criteria
- >6 months from last stroke
- aged ≥18 years
- Cantonese language fluency
- ≥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
- adequate opportunities for sleep.
Exclusion criteria
- presence of an active and progressive physical or neurocognitive illness or substance abuse making participation infeasible
- past or current involvement in psychological treatment for sleep issues
- night shift work
- pregnancy or breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 1 center
- The Hong Kong Polytechnic University — Hong Kong
Identifiers
NCT: NCT07731516 · HSEARS20250925007 · 23240951