CIEL: Intervention Study in Elderly With Sleep Problems

Sponsor

Mirjam Münch (Other)

Overall Status

Recruiting

CT.gov ID

NCT05485415

Collaborator

University of California (Other)

Enrollment

Locations

Arms

35.5

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Disturbance	Behavioral: Multimodal intervention Behavioral: Control	N/A

Detailed Description

The study lasts for 19 months and contains 7 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 4 visits (spread over 12 months) at the participants' homes, different measurements will be performed such as saliva collection, questionnaires, cognitive performance tests, light and rest-activity measures. A follow-up visit 6 months after completion of the last data collection will provide qualitative feedback by the participants.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

86 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Clinical Trial with a control groupRandomized Clinical Trial with a control group

Masking:

Single (Participant)

Masking Description:

Participants are unaware whether they are in the intervention or the control group

Primary Purpose:

Other

Official Title:

Personalised Circadian Intervention Study in Elderly With Sleep Problems

Actual Study Start Date :

Jul 15, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Intervention

Personalised intervention

Behavioral: Multimodal intervention

Participants in the intervention group will receive personalised advice on sleep, light exposure, meal times and physical activity.

Placebo Comparator: Control

General sleep advice

Behavioral: Control

General sleep advice

Outcome Measures

Primary Outcome Measures

Subjective sleep quality [1 year]
Pittsburgh Sleep Quality Index (Score > 5 indicates poor sleep)

Secondary Outcome Measures

Sleep timing [1 year]
Derived from Activity Watches
Subjective wellbeing [1 year]
Visual Analogue Scales
Salivary melatonin concentration [1 year]
Circadian phase marker
Pupil size [1 year]
Pupil response to chromatic light stimuli
Glucose metabolism [1 year]
HbA1c concentration (blood)
Telomere length [1 year]
Age marker

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Chronobiology, Psychiatric Hospital of the University of Basel	Basel	BS	Switzerland	4002
2	Centre for Chronobiology, Psychiatric Hopspital of the University of Basel	Basel		Switzerland	4002