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

NCT07784946 | Recruiting

• 1 other identifier: P0054797
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mild Cognitive Impairment; Dementia; Sleep

Outcome Measures

Primary Outcomes (1)

• Sleep disturbance

  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 Outcomes (4)

• Dysfunctional beliefs and attitudes about sleep

  Baseline and immediately post-intervention

• Emotional distress

  Baseline and immediately post-intervention

• Cognitive function

  Baselin and immediately post-intervention

• Health related quality of life

  Baseline and immediately post-intervention

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

OTHER

The control group will only receive usual care provided by community services

Other: control group

Interventions

AI-supported behavioral sleep intervention BEHAVIORAL

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

Intervention

control group OTHER

Usual care

Control

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Hung Hom, Hong Kong

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Shanshan Wang, PhD

CONTACT

27664696; shan-shan.wang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)