Insomnia, Sleep
Conditions
Keywords
Artificial Intelligence, Sleep, Insomnia, Older adults, Subjective cognitive decline, Pilot randomized controlled trial, Cognitive behavioral therapy for insomnia
Brief 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.
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.
Interventions
BEHAVIORALArtificial Intelligence (AI)-assisted sleep intervention
Six weeks of AI-assisted sleep intervention
BEHAVIORALUsual Care
The standard care participants receive from the healthcare system and/or their daily routines to address insomnia symptoms
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
CONTACTShanshan Prof. Wang, PhD
Outcome results
None listed