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| Name | Class |
|---|---|
| University of California | OTHER |
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The main objective of the study is to improve subjective sleep quality using a multimodal intervention with an intervention and a control group. The multimodal intervention aims to improve circadian Zeitgeber strength. This will be achieved by optimizing daily light exposure, sleep, physical activity, and mealtimes.
The study lasts for 14 months and contains 6 visits. After the screening visit at the Centre for Chronobiology, Basel, Switzerland, participants are assigned to either the intervention or the control group which is followed by a 7-day baseline week at home and a co-design meeting to provide instructions to the intervention and the control group. At the occasion of 2 visits (spread over 6 months) at the participants' homes, different measurements will be performed such as saliva collection, questionnaires, cognitive performance tests, light and rest-activity measures. After the last visit at home, participants come for the second blood sample at the study centre. A follow-up visit 6 months after completion of the last data collection will provide qualitative feedback by the participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Personalised intervention |
|
| Control | Placebo Comparator | General sleep advice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal intervention | Behavioral | Participants in the intervention group will receive personalised advice on sleep, light exposure, meal times and physical activity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective sleep quality | Pittsburgh Sleep Quality Index (Score > 5 indicates poor sleep) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep timing | Derived from Activity Watches | 6 months |
| Subjective wellbeing | Visual Analogue Scales | 6 months |
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Inclusion Criteria:
at least 65 years old women and men
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mirjam Münch, PhD | Research Associate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Chronobiology, Psychiatric Hopspital of the University of Basel | Basel | 4002 | Switzerland |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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Randomized Clinical Trial with a control group
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Participants are unaware whether they are in the intervention or the control group
| Control | Behavioral | General sleep advice |
|
| Salivary melatonin concentration | Circadian phase marker | 6 months |
| Pupil size | Pupil response to chromatic light stimuli | 6 months |
| Glucose metabolism | HbA1c concentration (blood) | 6 months |
| Telomere length | Age marker | 6 months |
| Neuropsychological Battery to assess working memory and attention (including n-back, Psychomotor Vigilance Test) | Cognitive Function | 6 months |