A Behavioural Sleep Intervention for People With Mild Cognitive Impairment and Mild Dementia

August 21, 2026 updated by: The Hong Kong Polytechnic University

A Behavioural Sleep Intervention Enabled by a Virtual Coach for People With Mild Cognitive Impairment and Mild Dementia: A Proof-of-concept Study

This is two arm pilot randomized controlled trial, with the intervention gorup receiving AI-supported behavioral sleep intervention and control group receiving usual care

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosis of mild cognitive impairment or dementia with the global deterioration scale (GDS) score at 4 or lower; endorse one or more sleep problems; experience sleep issues an average of 3 or more nights per week over the past month; reachable by phone; ability to provide informed consent and willingness to participate in the study.

Exclusion Criteria:

  • have a prior diagnosis of a primary sleep disorder (e.g., sleep apnoea); have a severe chronic illness that may cause sleep problems (e.g., emphysema); currently receiving medical, psychological, or psychiatric treatment for sleep disturbance or depression; severe visual or hearing impairment; uncontrolled medical conditions that may interfere with participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The intervention group will receive 6 weekly sessions of AI-supported behavioural sleep intervention, including 6 group sessions and daily use of AI-sleep companion. They can still receive usual care provided by community services
Behavioral: AI-supported behavioral sleep intervention
Participants will receive 6 weekly sessions of group education and daily use of the AI sleep companion
Other: Control
The control group will only receive usual care provided by community services
Other: control group
Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep disturbance
Time Frame: Baseline, immediately post-intervention (6 weeks)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality.
Baseline, immediately post-intervention (6 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysfunctional beliefs and attitudes about sleep
Time Frame: Baseline and immediately post-intervention
The Dysfunctional Beliefs and Attitudes about Sleep scale will be used
Baseline and immediately post-intervention
Emotional distress
Time Frame: Baseline and immediately post-intervention
will be measured with the Depression, Anxiety, and Stress-21 Scale
Baseline and immediately post-intervention
Cognitive function
Time Frame: Baselin and immediately post-intervention
Montreal Cognitive Assessment (MoCA) 5-min Hong Kong version will be used
Baselin and immediately post-intervention
Health related quality of life
Time Frame: Baseline and immediately post-intervention
EQ-5D will be used
Baseline and immediately post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

August 21, 2026

First Submitted That Met QC Criteria

August 21, 2026

First Posted (Actual)

August 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0054797

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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