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NCT Number: NCT07731516

Personalised Sleep and Circadian Intervention After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Sleep Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ISleepFAST

Behavioral

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 Education

Behavioral

A six-week education program providing general information about stroke, sleep, and health.

Primary outcomes

  1. 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.

  2. Participant Retention

    Time frame: From enrollment through completion of the 3-month follow-up.

    Number and proportion of enrolled participants who complete the study.

  3. Intervention Attendance

    Time frame: Up to 6 weeks.

    Number and proportion of the six scheduled intervention sessions attended by participants.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Change in Sleep and Circadian Sleep-Wake Functioning

    Time frame: 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.

  2. Change in Sleep Disturbance

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephen Lau

CONTACT

[email protected]

+852 2766 4283

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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