InsomniaNCT07588035
Artificial Intelligence (AI)-Assisted Sleep Intervention for Insomnia in Older Adults With Subjective Cognitive Decline
A study testing Artificial Intelligence (AI)-assisted sleep intervention in people with Insomnia and Sleep, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
To assess the feasibility and acceptability of Artificial Intelligence (AI)-assisted sleep intervention on improving the insomnia of older adults with subjective cognitive decline. Read more about this study
- Who is it for?
- Ages 60 years and older
- What is being tested?
- Artificial Intelligence (AI)-assisted 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 siteChina
- Study dates
- 20 Apr 2026to 1 Sep 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older adults aged ≥ 60 years
- Subjective cognitive decline questionnaire 9 (SCD-Q9) ≥ 5
- Montreal Cognitive Assessment (MoCA) ≥ 26. If the number of years of education is less than 12, one point will be added to the total score;
- with insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and Insomnia Severity Index (ISI) ≥ 8
- reachable by phone
Who cannot join
- having a previously diagnosed primary sleep disorder, such as sleep apnoea
- suffering from a severe chronic illness that could contribute to sleep problems (e.g., emphysema)
- currently undergoing medical, psychological, or psychiatric treatment for sleep disturbances or depression
- having significant visual or hearing impairments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Qingyuan Second People's Hospital
Qingyuan, Guangdong, 511800
Yuting Xia, +8613940095971, yuting.xia@connect.polyu.hk
About this study
Official title: Artificial Intelligence (AI)-Assist Sleep Intervention for Insomnia Among Older Adults With Subjective Cognitive Decline: A Pilot Randomized Controlled Trial
To assess the feasibility and acceptability of Artificial Intelligence (AI)-assisted sleep intervention on improving the insomnia of older adults with subjective cognitive decline.
Read the detailed description
This is a two-arm pilot randomized controlled trial evaluating the feasibility and acceptability of Artificial Intelligence (AI)-assisted sleep intervention on improving the insomnia of older adults with subjective cognitive decline. Sixty participants will be rectuited. Participants in the intervention group will receive a 6-week AI-assisted sleep intervention, while those in the control group will receive usual care. Outcomes including feasibility and acceptability of the AI-assisted sleep intervention, insomnia, beliefs and attitudes of sleep, depression, and anxiety will be measured at baseline and immediately post intervention.
- Being tested
- Artificial Intelligence (AI)-assisted sleep intervention, Usual Care
- Keywords
- Artificial Intelligence, Sleep, Insomnia, Older adults, Subjective cognitive decline, Pilot randomized controlled trial, Cognitive behavioral therapy for insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence (AI)-assisted sleep interventionBehavioural
Six weeks of AI-assisted sleep intervention
Usual CareBehavioural
The standard care participants receive from the healthcare system and/or their daily routines to address insomnia symptoms
| Study group | Role | What they receive |
|---|---|---|
| Artificial Intelligence (AI)-assisted sleep intervention | Experimental | Not described Receives: Behavioral: Artificial Intelligence (AI)-assisted sleep intervention |
| Usual care | Active comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility rate
The number of screened participants who will be eligible.
Measured: Pre-intervention
Recruitment rate
The number of participants enrolled in the study
Measured: Pre-intervention
Adherence rate
The number of participants in the intervention and control groups who complete the intervention
Measured: Immediately post-intervention
Attrition rate
The percentage of enrolled participants who discontinue participation at any point during the study.
Measured: Immediately post-intervention
Engagement rate
The degree of mastery and use of the intervention content, measured by sleep diary data.
Measured: Immediately post-intervention
Retention rate
The number of participants who remain in the study
Measured: Immediately post-intervention
Acceptability
Participants' perceptions of and satisfaction with the intervention will be assessed through individual interviews.
Measured: Immediately post-intervention
Secondary outcomes (4)
Insomnia
Insomnia will be measured by Insomnia Severity Index (ISI) and actigraphy. The total score on ISI ranges from zero to 28 points, with a higher score indicating more severe insomnia. A total score between 0 and 7 indicates no clinical insomnia; a score of 8 to 14 suggests subthreshold insomnia; 15 to 21 indicates moderate insomnia; and 22 to 28 indicates severe insomnia. The actigraphy will be used in this study is Xiaomi Mi Band 10.
Measured: Pre-intervention and immediately post-intervention
Beliefs and attitudes of sleep
Beliefs and attitudes of sleep will be measured by the Dysfunctional Beliefs and Attitudes about Sleep Scale-16 (DBAS-16). The total score of the scale is 16-80 points. The higher the total score, the more correct the belief and attitude towards sleep.
Measured: Pre-intervention and immediately post-intervention
Depression
Depression will be measured by 15-item Geriatric Depression Scale (GDS-15). The total score on the scale ranges from zero to 15 points, with the total score above eight points indicating the presence of depression. Higher scores indicate more severe depression.
Measured: Pre-intervention and immediately post-intervention
Anxiety
Anxiety will be measured by Generalized Anxiety Disorder Scale. The total score of the scale is 0-21 points, with no anxiety below 5 points, mild anxiety of 5-9 points, moderate anxiety of 10-14 points, and severe anxiety above 14 points.Higher scores indicate more severe anxiety.
Measured: Pre-intervention 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 posted14 May 2026
- Study start20 Apr 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Outcomes assessor
- 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
- NCT07588035
- Sponsor's protocol ID
- HSEARS20251101004
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- 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 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence (AI)-Assist Sleep Intervention for Insomnia Among Older Adults With Subjective Cognitive Decline: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07588035
- Acronym / sponsor ID
- HSEARS20251101004
- Keywords
- Artificial Intelligence, Sleep, Insomnia, Older adults, Subjective cognitive decline, Pilot randomized controlled trial, Cognitive behavioral therapy for insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 14 May 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.
To assess the feasibility and acceptability of Artificial Intelligence (AI)-assisted sleep intervention on improving the insomnia of older adults with subjective cognitive decline.
Detailed description
This is a two-arm pilot randomized controlled trial evaluating the feasibility and acceptability of Artificial Intelligence (AI)-assisted sleep intervention on improving the insomnia of older adults with subjective cognitive decline. Sixty participants will be rectuited. Participants in the intervention group will receive a 6-week AI-assisted sleep intervention, while those in the control group will receive usual care. Outcomes including feasibility and acceptability of the AI-assisted sleep intervention, insomnia, beliefs and attitudes of sleep, depression, and anxiety will be measured at baseline and immediately post intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial Intelligence (AI)-assisted sleep intervention | Experimental | Behavioral: Artificial Intelligence (AI)-assisted sleep intervention |
| Usual care | Active comparator | Behavioral: Usual Care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- older adults aged ≥ 60 years
- Subjective cognitive decline questionnaire 9 (SCD-Q9) ≥ 5
- Montreal Cognitive Assessment (MoCA) ≥ 26. If the number of years of education is less than 12, one point will be added to the total score;
- with insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and Insomnia Severity Index (ISI) ≥ 8
- reachable by phone
Key exclusion criteria (4 listed)
- having a previously diagnosed primary sleep disorder, such as sleep apnoea
- suffering from a severe chronic illness that could contribute to sleep problems (e.g., emphysema)
- currently undergoing medical, psychological, or psychiatric treatment for sleep disturbances or depression
- having significant visual or hearing impairments.
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 |
|---|---|---|
| Artificial Intelligence (AI)-assisted sleep interventionSix weeks of AI-assisted sleep intervention | Behavioural | Artificial Intelligence (AI)-assisted sleep intervention |
| Usual CareThe standard care participants receive from the healthcare system and/or their daily routines to address insomnia symptoms | Behavioural | Usual care |
Primary outcome
Eligibility rate
Time frame: Pre-intervention
The number of screened participants who will be eligible.
Recruitment rate
Time frame: Pre-intervention
The number of participants enrolled in the study
Adherence rate
Time frame: Immediately post-intervention
The number of participants in the intervention and control groups who complete the intervention
Attrition rate
Time frame: Immediately post-intervention
The percentage of enrolled participants who discontinue participation at any point during the study.
Engagement rate
Time frame: Immediately post-intervention
The degree of mastery and use of the intervention content, measured by sleep diary data.
Retention rate
Time frame: Immediately post-intervention
The number of participants who remain in the study
Acceptability
Time frame: Immediately post-intervention
Participants' perceptions of and satisfaction with the intervention will be assessed through individual interviews.
4 secondary outcomes
Insomnia
Time frame: Pre-intervention and immediately post-intervention
Beliefs and attitudes of sleep
Time frame: Pre-intervention and immediately post-intervention
Depression
Time frame: Pre-intervention and immediately post-intervention
Anxiety
Time frame: Pre-intervention 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 14 May 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 Artificial Intelligence (AI)-assisted sleep intervention in people with Insomnia and Sleep, run by The Hong Kong Polytechnic University at 1 site in China.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 14 May 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 China. 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 Prof. Wang, PhD (+85227664696, 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?
Eligibility rate (time frame: Pre-intervention). The study lists 7 primary outcomes in all. 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 14 May 2026.