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

8. maj 2026 opdateret af: The Hong Kong Polytechnic University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Guangdong
      • Qingyuan, Guangdong, Kina, 511800

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Sædvanlig pleje
Adfærdsmæssigt: Usual Care
The standard care participants receive from the healthcare system and/or their daily routines to address insomnia symptoms
Eksperimentel: Artificial Intelligence (AI)-assisted sleep intervention
Adfærdsmæssigt: Artificial Intelligence (AI)-assisted sleep intervention
Six weeks of AI-assisted sleep intervention

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Insomnia
Tidsramme: 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.
Pre-intervention and immediately post-intervention
Beliefs and attitudes of sleep
Tidsramme: 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.
Pre-intervention and immediately post-intervention
Depression
Tidsramme: 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.
Pre-intervention and immediately post-intervention
Anxiety
Tidsramme: 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.
Pre-intervention and immediately post-intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Hong Kong Polytechnic University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. april 2026

Primær færdiggørelse (Anslået)

1. september 2027

Studieafslutning (Anslået)

1. september 2027

Datoer for studieregistrering

Først indsendt

17. april 2026

Først indsendt, der opfyldte QC-kriterier

8. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HSEARS20251101004

Plan for individuelle deltagerdata (IPD)

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