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

NCT07588035 | Not Yet Recruiting

• 1 other identifier: HSEARS20251101004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia; Sleep

Keywords

Artificial Intelligence; Sleep; Insomnia; Older adults; Subjective cognitive decline; Pilot randomized controlled trial; Cognitive behavioral therapy for insomnia

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Insomnia

  Pre-intervention and immediately post-intervention

• Beliefs and attitudes of sleep

  Pre-intervention and immediately post-intervention

• Depression

  Pre-intervention and immediately post-intervention

• Anxiety

  Pre-intervention and immediately post-intervention

Study Arms (2)

Artificial Intelligence (AI)-assisted sleep intervention

EXPERIMENTAL

Behavioral: Artificial Intelligence (AI)-assisted sleep intervention

Usual care

ACTIVE COMPARATOR

Behavioral: Usual Care

Interventions

Artificial Intelligence (AI)-assisted sleep intervention BEHAVIORAL

Six weeks of AI-assisted sleep intervention

Artificial Intelligence (AI)-assisted sleep intervention

Usual Care BEHAVIORAL

The standard care participants receive from the healthcare system and/or their daily routines to address insomnia symptoms

Usual care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

Qingyuan Second People's Hospital

Qingyuan, Guangdong, 511800, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Artificial Intelligence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Algorithms; Mathematical Concepts

Central Study Contacts

Shanshan Prof. Wang, PhD

CONTACT

+85227664696; shan-shan.wang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 14, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)