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Personalised Sleep and Circadian Intervention After Stroke

NCT07731516 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • The Hong Kong Polytechnic University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07731516 on ClinicalTrials.gov