ClinicalTrials.gg
RecruitingNCT07784946Updated Aug 25, 2026

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

An interventional study of AI-supported behavioral sleep intervention and control group in Mild Cognitive Impairment, Dementia and Sleep, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2026, registered Aug 2026).
  • Started Jan 2026; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 21 studies in Cognitive Dysfunction by The Hong Kong Polytechnic University — 11 open to participants now, 11 under way, none of them phase 3. Cognitive Dysfunction · The Hong Kong Polytechnic University.

Planned enrollment
12th of 19
60 · median 66
Started
2026
with 1 other
No phase
19 of 21
9 open now
Primary completion
2027-07
later than 10 of 10 live
Registered
21st of 21
by date

Among the 21 studies in Cognitive Dysfunction by The Hong Kong Polytechnic University, this one is the 12th largest by planned enrollment of the 19 interventional ones, is one of 2 that started in 2026, is one of 19 with no phase, reaches primary completion later than 10 of the 10 other live ones, and was the 21st registered.

By phase

21 studies; the count open now beside each. This study's row is marked.

No phasethis study19 · 9 open
Observational2 · 2 open

By the year they started

First in 2012; this study’s year is marked. 2 started in 2026.

Size and results

Median enrollment 66 across the 19 interventional studies, 70 across the 2 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 21 studies in Cognitive Dysfunction by The Hong Kong Polytechnic University, or all of them as a file.
02

Study 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

03

Conditions studied

  • Mild Cognitive Impairment
  • Dementia
  • Sleep
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and willingness to participate in the study.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • Other
    Control

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

    Other: control group

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

06

What researchers measure

Primary outcomes

  1. Sleep disturbance

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality.

    Time frame: Baseline, immediately post-intervention (6 weeks)

Secondary outcomes

  1. Dysfunctional beliefs and attitudes about sleep

    The Dysfunctional Beliefs and Attitudes about Sleep scale will be used

    Time frame: Baseline and immediately post-intervention

  2. Emotional distress

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

    Time frame: Baseline and immediately post-intervention

  3. Cognitive function

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

    Time frame: Baselin and immediately post-intervention

  4. Health related quality of life

    EQ-5D will be used

    Time frame: Baseline and immediately post-intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Jul 2027, 18 months after the start.

Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 18 months is below that.

Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 21, 2026
First posted
Aug 25, 2026
StartActual
Jan 1, 2026
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2027
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07784946
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Jan 1, 2026
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Aug 25, 2026

Study contacts

Shanshan Wang, PhD
Contact
shan-shan.wang@polyu.edu.hk
27664696

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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