Artificial Intelligence (AI)-Assist Sleep Intervention for Insomnia Among Older Adults With Subjective Cognitive Decline: A Pilot Randomized Controlled Trial
| Registry | NCT07588035 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 60 (Estimated) |
| Sponsor | The Hong Kong Polytechnic University (Other) |
| Conditions | Insomnia, Sleep |
| Interventions | Artificial Intelligence (AI)-assisted sleep intervention, Usual Care (Behavioral) |
| Dates | start 2026-04-20 (estimated), primary completion 2027-09-01 (estimated), completion 2027-09-01 (estimated), first posted 2026-05-14, last updated 2026-05-14 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Insomnia All trials for Sleep All trials of Artificial Intelligence (AI)-assisted sleep intervention All trials of Usual Care
To assess the feasibility and acceptability of Artificial Intelligence (AI)-assisted sleep intervention on improving the insomnia of older adults with subjective cognitive decline.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Artificial Intelligence (AI)-assisted sleep intervention | Experimental | Behavioral: Artificial Intelligence (AI)-assisted sleep intervention | |
| Usual care | Active comparator | Behavioral: Usual Care |
Sex: All, ages: 60 Years to any
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Qingyuan Second People's Hospital | Qingyuan, Guangdong | China |