Personalised Sleep and Circadian Intervention After Stroke

NCT07731516 | Not Yet Recruiting

• 2 other identifiers: HSEARS2025092500723240951
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Sleep

Keywords

Stroke; Sleep; Circadian Rhythm

Outcome Measures

Primary Outcomes (6)

• Recruitment Rate

  Number of participants enrolled divided by the number of months of active recruitment.

  From the start of recruitment through completion of recruitment

• Participant Retention

  Number and proportion of enrolled participants who complete the study.

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

• Intervention Attendance

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

  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.

  Immediately after the 6-week intervention.

• Number of Adverse Events

  Number of any adverse events during the study.

  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.

  Throughout the 6-week intervention period.

Secondary Outcomes (2)

• Change in Sleep and Circadian Sleep-Wake Functioning

  Baseline, immediately after the intervention, 3-month follow-up

• Change in Sleep Disturbance

  Baseline, immediately after the 6-week intervention, and 3 months after the intervention.

Study Arms (2)

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.

Behavioral: ISleepFAST

Stroke and Sleep Health Education

ACTIVE COMPARATOR

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

Behavioral: Stroke and Sleep Health Education

Interventions

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.

ISleepFAST

Stroke and Sleep Health Education BEHAVIORAL

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

Stroke and Sleep Health Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Stephen Lau

CONTACT

+852 2766 4283; chun-lun-stephen.lau@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 17, 2026
• First Posted: July 28, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)