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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07784946

Enrollment

Registered

2026-08-25

Start date

2026-01-01

Completion date

2027-07-01

Last updated

2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Mild Cognitive Impairment, Sleep

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

Interventions

BEHAVIORALAI-supported behavioral sleep intervention

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

OTHERcontrol group

Usual care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Sleep disturbance	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

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

Countries

Hong Kong

Contacts

CONTACTShanshan Wang, PhD

shan-shan.wang@polyu.edu.hk27664696

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026