Intervention Study in Elderly With Sleep Problems (CIEL)

Personalised Circadian Intervention Study in Elderly With Sleep Problems

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sleep Disturbance
• Intervention / Treatment: Behavioral: Multimodal intervention; Behavioral: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4002
    • Centre for Chronobiology, Psychiatric Hopspital of the University of Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

at least 65 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mirjam Münch
• Collaborators: University of California
• Investigators: Principal Investigator: Mirjam Münch, PhD, Research Associate

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 24, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: health; sleep; cognition; circadian; light; personalized; Zeitgeber; muliti-modal
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: 2022-00904

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No