About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Artificial Intelligence (AI)-assisted sleep intervention
BehavioralSix weeks of AI-assisted sleep intervention
Usual Care
BehavioralThe standard care participants receive from the healthcare system and/or their daily routines to address insomnia symptoms
Treatment groups
Trial outcomes
Primary outcomes
Eligibility rate
The number of screened participants who will be eligible.
Recruitment rate
The number of participants enrolled in the study
Adherence rate
The number of participants in the intervention and control groups who complete the intervention
Attrition rate
The percentage of enrolled participants who discontinue participation at any point during the study.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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