Personalised Sleep and Circadian Intervention After Stroke

The Hong Kong Polytechnic University

Status: Not yet enrolling

Conditions: Stroke; Sleep

Treatments: Behavioral: ISleepFAST; Behavioral: Stroke and Sleep Health Education

Study type: Interventional

Funder types: Other

Identifiers

NCT07731516

23240951 (Other Grant/Funding Number)

HSEARS20250925007

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. >6 months from last stroke
2. aged ≥18 years
3. Cantonese language fluency
4. ≥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
5. adequate opportunities for sleep.

Exclusion criteria

1. presence of an active and progressive physical or neurocognitive illness or substance abuse making participation infeasible
2. past or current involvement in psychological treatment for sleep issues
3. night shift work
4. pregnancy or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

ISleepFAST

Experimental group

Description:

Participants will receive ISleepFAST, a six-week individualized behavioral sleep intervention delivered in six weekly, face-to-face sessions of approximately 60 minutes each.

Treatment:

Behavioral: ISleepFAST

Stroke and Sleep Health Education

Active Comparator group

Description:

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

Treatment:

Behavioral: Stroke and Sleep Health Education