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NCT Number: NCT07784946

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

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

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Key information

Conditions

Mild Cognitive Impairment Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Kowloon, Hung Hom, Hong Kong

Location status: Recruiting

Location contact

Shanshan Wang

CONTACT

[email protected]

27664696

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

AI-supported behavioral sleep intervention

Behavioral

Participants will receive 6 weekly sessions of group education and daily use of the AI sleep companion

Control Group

Other

Usual care

Primary outcomes

  1. 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.

Secondary outcomes

  1. Dysfunctional beliefs and attitudes about sleep

    Time frame: Baseline and immediately post-intervention

    The Dysfunctional Beliefs and Attitudes about Sleep scale will be used

  2. Emotional distress

    Time frame: Baseline and immediately post-intervention

    will be measured with the Depression, Anxiety, and Stress-21 Scale

  3. Cognitive function

    Time frame: Baselin and immediately post-intervention

    Montreal Cognitive Assessment (MoCA) 5-min Hong Kong version will be used

  4. Health related quality of life

    Time frame: Baseline and immediately post-intervention

    EQ-5D will be used

Study contacts

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

Shanshan Wang, PhD

CONTACT

[email protected]

27664696

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 25, 2026
Registry last updated
Aug 25, 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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