Artificial Intelligence (AI)-Assisted Sleep Intervention for Insomnia in Older Adults With Subjective Cognitive Decline
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Artificial Intelligence (AI)-assisted sleep intervention, Usual Care.
- Who it may be relevant to
- Registry conditions: Insomnia, Sleep. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Artificial Intelligence (AI)-Assist Sleep Intervention for Insomnia Among Older Adults With Subjective Cognitive Decline: A Pilot Randomized Controlled Trial
Overview
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.
Interventions
- Behavioral Artificial Intelligence (AI)-assisted sleep intervention
Six weeks of AI-assisted sleep intervention - Behavioral Usual Care
The standard care participants receive from the healthcare system and/or their daily routines to address insomnia symptoms
Primary outcome measures
- Eligibility rate [Time frame: Pre-intervention]
- Recruitment rate [Time frame: Pre-intervention]
- Adherence rate [Time frame: Immediately post-intervention]
- Attrition rate [Time frame: Immediately post-intervention]
- Engagement rate [Time frame: Immediately post-intervention]
- Retention rate [Time frame: Immediately post-intervention]
- Acceptability [Time frame: Immediately post-intervention]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
China · 1 center
- Qingyuan Second People's Hospital — Qingyuan
Identifiers
NCT: NCT07588035 · HSEARS20251101004