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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Intelligence (AI)-assisted sleep intervention | Experimental |
| |
| Usual care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Intelligence (AI)-assisted sleep intervention | Behavioral | Six weeks of AI-assisted sleep intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eligibility rate | The number of screened participants who will be eligible. | Pre-intervention |
| Recruitment rate | The number of participants enrolled in the study | Pre-intervention |
| Adherence rate | The number of participants in the intervention and control groups who complete the intervention | Immediately post-intervention |
| Attrition rate | The percentage of enrolled participants who discontinue participation at any point during the study. | Immediately post-intervention |
| Engagement rate | The degree of mastery and use of the intervention content, measured by sleep diary data. | Immediately post-intervention |
| Retention rate | The number of participants who remain in the study | Immediately post-intervention |
| Acceptability | Participants' perceptions of and satisfaction with the intervention will be assessed through individual interviews. | Immediately post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shanshan Prof. Wang, PhD | Contact | +85227664696 | shan-shan.wang@polyu.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qingyuan Second People's Hospital | Qingyuan | Guangdong | 511800 | China |
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| Usual Care | Behavioral | The standard care participants receive from the healthcare system and/or their daily routines to address insomnia symptoms |
|
| 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. | 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. | 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. | Pre-intervention and immediately post-intervention |
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D001185 | Artificial Intelligence |
| ID | Term |
|---|---|
| D000465 | Algorithms |
| D055641 | Mathematical Concepts |
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