Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07588035

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

To assess the feasibility and acceptability of Artificial Intelligence (AI)-assisted sleep intervention on improving the insomnia of older adults with subjective cognitive decline.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artificial Intelligence (AI)-assisted sleep intervention

Behavioral

Six weeks of 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

Primary outcomes

  1. Eligibility rate

    Time frame: Pre-intervention

    The number of screened participants who will be eligible.

  2. Recruitment rate

    Time frame: Pre-intervention

    The number of participants enrolled in the study

  3. Adherence rate

    Time frame: Immediately post-intervention

    The number of participants in the intervention and control groups who complete the intervention

  4. Attrition rate

    Time frame: Immediately post-intervention

    The percentage of enrolled participants who discontinue participation at any point during the study.

  5. Engagement rate

    Time frame: Immediately post-intervention

    The degree of mastery and use of the intervention content, measured by sleep diary data.

  6. Retention rate

    Time frame: Immediately post-intervention

    The number of participants who remain in the study

  7. Acceptability

    Time frame: Immediately post-intervention

    Participants' perceptions of and satisfaction with the intervention will be assessed through individual interviews.

Secondary outcomes

  1. Insomnia

    Time frame: Pre-intervention and immediately post-intervention

    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.

  2. Beliefs and attitudes of sleep

    Time frame: Pre-intervention and immediately post-intervention

    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.

  3. Depression

    Time frame: Pre-intervention and immediately post-intervention

    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.

  4. Anxiety

    Time frame: Pre-intervention and immediately post-intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shanshan Prof. Wang, PhD

CONTACT

[email protected]

+85227664696

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

Artificial Intelligence (AI)-Assist Sleep Intervention for Insomnia Among Older Adults With Subjective Cognitive Decline: A Pilot Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.