Artificial Intelligence (AI)-Assisted Sleep Intervention for Insomnia in Older Adults With Subjective Cognitive Decline

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia; Sleep
• Intervention / Treatment: Behavioral: Artificial Intelligence (AI)-assisted sleep intervention; Behavioral: Usual Care

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shanshan Prof. Wang, PhD; Phone Number: +85227664696; Email: shan-shan.wang@polyu.edu.hk

Study Locations

• China
  • Guangdong
    • Qingyuan, Guangdong, China, 511800
      • Qingyuan Second People's Hospital
      • Contact: Yuting Xia; Phone Number: +8613940095971; Email: yuting.xia@connect.polyu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care	Behavioral: Usual Care; The standard care participants receive from the healthcare system and/or their daily routines to address insomnia symptoms
Experimental: Artificial Intelligence (AI)-assisted sleep intervention	Behavioral: Artificial Intelligence (AI)-assisted sleep intervention; Six weeks of AI-assisted sleep intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eligibility rate	The number of screened participants who will be eligible.	Pre-intervention
Recruitment rate	The number of participants enrolled in the study	Pre-intervention
Adherence rate	The number of participants in the intervention and control groups who complete the intervention	Immediately post-intervention
Attrition rate	The percentage of enrolled participants who discontinue participation at any point during the study.	Immediately post-intervention
Engagement rate	The degree of mastery and use of the intervention content, measured by sleep diary data.	Immediately post-intervention
Retention rate	The number of participants who remain in the study	Immediately post-intervention
Acceptability	Participants' perceptions of and satisfaction with the intervention will be assessed through individual interviews.	Immediately post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Pre-intervention and immediately post-intervention

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Sleep; Insomnia; Artificial Intelligence; Older adults; Subjective cognitive decline; Pilot randomized controlled trial; Cognitive behavioral therapy for insomnia
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders; Algorithms; Mathematical Concepts; Artificial Intelligence
• Other Study ID Numbers: HSEARS20251101004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No