StrokeNCT07731516
Personalised Sleep and Circadian Intervention After Stroke
A study testing ISleepFAST and Stroke and Sleep Health Education in people with Stroke and Sleep, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- ISleepFAST and Stroke and Sleep Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
The Hong Kong Polytechnic University
Hong Kong
Stephen Lau, +852 2766 4283, chun-lun-stephen.lau@polyu.edu.hk
About this study
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
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.
Read more
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.
- Being tested
- ISleepFAST, Stroke and Sleep Health Education
- Keywords
- Stroke, Sleep, Circadian Rhythm
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISleepFASTBehavioural
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.
Stroke and Sleep Health EducationBehavioural
A six-week education program providing general information about stroke, sleep, and health.
| Study group | Role | What they receive |
|---|---|---|
| ISleepFAST | Experimental | Participants will receive ISleepFAST, a six-week individualized behavioral sleep intervention delivered in six weekly, face-to-face sessions of approximately 60 minutes each. Receives: Behavioral: ISleepFAST |
| Stroke and Sleep Health Education | Active comparator | A six-week education program providing general information about stroke, sleep, and health. Receives: Behavioral: Stroke and Sleep Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of participants enrolled divided by the number of months of active recruitment.
Measured: From the start of recruitment through completion of recruitment
Participant Retention
Number and proportion of enrolled participants who complete the study.
Measured: From enrollment through completion of the 3-month follow-up.
Intervention Attendance
Number and proportion of the six scheduled intervention sessions attended by participants.
Measured: 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.
Measured: Immediately after the 6-week intervention.
Number of Adverse Events
Number of any adverse events during the study.
Measured: 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.
Measured: Throughout the 6-week intervention period.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, immediately after the 6-week intervention, and 3 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. LAU Chun Lun Stephen, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731516
- Sponsor's protocol ID
- HSEARS20250925007
- Other IDs
- 23240951
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07731516
- Acronym / sponsor ID
- HSEARS20250925007
- Keywords
- Stroke, Sleep, Circadian Rhythm
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISleepFAST | Experimental | Behavioral: ISleepFASTParticipants will receive ISleepFAST, a six-week individualized behavioral sleep intervention delivered in six weekly, face-to-face sessions of approximately 60 minutes each. |
| Stroke and Sleep Health Education | Active comparator | Behavioral: Stroke and Sleep Health EducationA six-week education program providing general information about stroke, sleep, and health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISleepFASTA 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. | Behavioural | ISleepFAST |
| Stroke and Sleep Health EducationA six-week education program providing general information about stroke, sleep, and health. | Behavioural | Stroke and Sleep Health Education |
Primary outcome
Recruitment Rate
Time frame: From the start of recruitment through completion of recruitment
Number of participants enrolled divided by the number of months of active recruitment.
Participant Retention
Time frame: From enrollment through completion of the 3-month follow-up.
Number and proportion of enrolled participants who complete the study.
Intervention Attendance
Time frame: Up to 6 weeks.
Number and proportion of the six scheduled intervention sessions attended by participants.
Acceptability
Time frame: 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
Time frame: From enrollment through the 3-month follow-up, up to approximately 5 months.
Number of any adverse events during the study.
Fidelity
Time frame: 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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISleepFAST and Stroke and Sleep Health Education in people with Stroke and Sleep, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Lau (+852 2766 4283, chun-lun-stephen.lau@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: From the start of recruitment through completion of recruitment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.