Mild Cognitive ImpairmentNCT07784946
A Behavioural Sleep Intervention for People With Mild Cognitive Impairment and Mild Dementia
A study testing AI-supported behavioral sleep intervention in people with Mild Cognitive Impairment and Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Dementia, Sleep
- What is being tested?
- AI-supported behavioral sleep intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Kowloon, Hung Hom
Shanshan Wang, 27664696, shan-shan.wang@polyu.edu.hk
About this study
Official title: 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
- Conditions
- Mild Cognitive Impairment, Dementia, Sleep
- Being tested
- AI-supported behavioral sleep intervention, control group
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-supported behavioral sleep interventionBehavioural
Participants will receive 6 weekly sessions of group education and daily use of the AI sleep companion
control groupOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: AI-supported behavioral sleep intervention |
| Control | Other | The control group will only receive usual care provided by community services Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep disturbance
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality.
Measured: Baseline, immediately post-intervention (6 weeks)
Secondary outcomes (4)
Dysfunctional beliefs and attitudes about sleep
The Dysfunctional Beliefs and Attitudes about Sleep scale will be used
Measured: Baseline and immediately post-intervention
Emotional distress
will be measured with the Depression, Anxiety, and Stress-21 Scale
Measured: Baseline and immediately post-intervention
Cognitive function
Montreal Cognitive Assessment (MoCA) 5-min Hong Kong version will be used
Measured: Baselin and immediately post-intervention
Health related quality of life
EQ-5D will be used
Measured: Baseline and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Jan 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784946
- Sponsor's protocol ID
- P0054797
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Behavioural Sleep Intervention Enabled by a Virtual Coach for People With Mild Cognitive Impairment and Mild Dementia: A Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT07784946
- Acronym / sponsor ID
- P0054797
- Conditions
- Mild Cognitive Impairment, Dementia, Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: AI-supported behavioral sleep interventionThe 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 |
| Control | Other | Other: control groupThe control group will only receive usual care provided by community services |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-supported behavioral sleep interventionParticipants will receive 6 weekly sessions of group education and daily use of the AI sleep companion | Behavioural | Intervention |
| control groupUsual care | Other | Control |
Primary outcome
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.
4 secondary outcomes
Dysfunctional beliefs and attitudes about sleep
Time frame: Baseline and immediately post-intervention
Emotional distress
Time frame: Baseline and immediately post-intervention
Cognitive function
Time frame: Baselin and immediately post-intervention
Health related quality of life
Time frame: Baseline and immediately post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-supported behavioral sleep intervention in people with Mild Cognitive Impairment and Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanshan Wang, PhD (27664696, shan-shan.wang@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep disturbance (time frame: Baseline, immediately post-intervention (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.