Intervention Study in Elderly With Sleep Problems

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Personalised Circadian Intervention Study in Elderly With Sleep Problems

Conditions
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Sleep Disturbance

Intervention / Treatment
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* Behavioral: Multimodal intervention
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 64 years old women and men Pittsburgh Sleep Quality Index (PSQI) > 5 (indicative of sleep problems) Living at home (including self-serviced retirement apartment) Exclusion Criteria: Total blindness or VA < 0.5 Progressive NCDs (e.g., cancer) Acute infections (e.g., Covid-19) Neurodegenerative disease Psychiatric disease Sleep disorder (sleep apnea, narcolepsy) Not German speaking

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Clinical Trial with a control group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Personalised intervention | Behavioral: Multimodal intervention<br>* Participants in the intervention group will receive personalised advice on sleep, light exposure, meal times and physical activity.<br>|
| Placebo Comparator: Control<br>General sleep advice | Behavioral: Control<br>* General sleep advice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective sleep quality | Pittsburgh Sleep Quality Index (Score > 5 indicates poor sleep) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep timing | Derived from Activity Watches | 6 months | 
| Subjective wellbeing | Visual Analogue Scales | 6 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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circadian, light, cognition, Zeitgeber, personalized, health, sleep, muliti-modal