To assess the feasibility and acceptability of Artificial Intelligence (AI)-assisted sleep intervention on improving the insomnia of older adults with subjective cognitive decline.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
60
Six weeks of AI-assisted sleep intervention
The standard care participants receive from the healthcare system and/or their daily routines to address insomnia symptoms
Qingyuan Second People's Hospital
Qingyuan, Guangdong, China
Eligibility rate
The number of screened participants who will be eligible.
Time frame: Pre-intervention
Recruitment rate
The number of participants enrolled in the study
Time frame: Pre-intervention
Adherence rate
The number of participants in the intervention and control groups who complete the intervention
Time frame: Immediately post-intervention
Attrition rate
The percentage of enrolled participants who discontinue participation at any point during the study.
Time frame: Immediately post-intervention
Engagement rate
The degree of mastery and use of the intervention content, measured by sleep diary data.
Time frame: Immediately post-intervention
Retention rate
The number of participants who remain in the study
Time frame: Immediately post-intervention
Acceptability
Participants' perceptions of and satisfaction with the intervention will be assessed through individual interviews.
Time frame: Immediately post-intervention
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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-intervention and immediately post-intervention