NCT05485415

Intervention Study in Elderly With Sleep Problems

Personalised Circadian Intervention Study in Elderly With Sleep Problems

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Mirjam Münch · Network
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Sleep Disturbance

Interventions

Type	Name	Description
BEHAVIORAL	Multimodal intervention	Participants in the intervention group will receive personalised advice on sleep, light exposure, meal times and physical activity.
BEHAVIORAL	Control	General sleep advice

Timeline

• Start date: 2022-07-15
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2022-08-03
• Last updated: 2025-03-28

Locations

1 site across 1 country: Switzerland