NCT07731516Not yet recruiting
Personalised Sleep and Circadian Intervention After Stroke
Feasibility, Efficacy, and Patient Experience of a Personalised Transdiagnostic Intervention for Sleep and Circadian Dysfunction Following Stroke: a Mixed-method Randomised Controlled Feasibility Trial
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 17 Jul 2026
- Start date
- Aug 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- The Hong Kong Polytechnic University
- Diseases
- Stroke
- NCT number
- NCT07731516
What you commit to
- Study type: Interventional
- Planned participants: 40
- From Aug 2026 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- presence of an active and progressive physical or neurocognitive illness or substance abuse making participation infeasible
Other
- past or current involvement in psychological treatment for sleep issues
- night shift work
- pregnancy or breastfeeding.
Who the study is looking for
- \>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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Hong Kong Polytechnic University Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.