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

NCT07588035 — Not applicable, Not yet recruiting, 60 participants, The Hong Kong Polytechnic University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT07588035
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, supportive care
Enrollment60 (Estimated)
SponsorThe Hong Kong Polytechnic University (Other)
ConditionsInsomnia, Sleep
InterventionsArtificial Intelligence (AI)-assisted sleep intervention, Usual Care (Behavioral)
Datesstart 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
Locations1 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

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Artificial Intelligence (AI)-assisted sleep interventionExperimentalBehavioral: Artificial Intelligence (AI)-assisted sleep intervention
Usual careActive comparatorBehavioral: Usual Care
  • 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

+Outcome measures

Primary outcomes

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

Secondary outcomes

  • Insomnia [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.
  • Beliefs and attitudes of sleep [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.
  • Depression [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.
  • Anxiety [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.

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Qingyuan Second People's HospitalQingyuan, GuangdongChina