Intervention Study in Elderly With Sleep Problems

Sleep Disturbance Clinical Trial

— CIEL  

Official title:

Personalised Circadian Intervention Study in Elderly With Sleep Problems

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05485415
• Other study ID #: 2022-00904
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: University Psychiatric Clinics Basel
• Contact: Mirjam Münch, PhD
• Phone: +41 61 325 2358
• Email: mirjam.muench[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Behavioral:
• Multimodal intervention
Participants in the intervention group will receive personalised advice on sleep, light exposure, meal times and physical activity.
• Control
General sleep advice

Locations

Country	Name	City	State
Switzerland	Centre for Chronobiology, Psychiatric Hopspital of the University of Basel	Basel
Switzerland	Centre for Chronobiology, Psychiatric Hospital of the University of Basel	Basel	BS

Sponsors (2)

Lead Sponsor	Collaborator
Mirjam Münch	University of California

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective sleep quality	Pittsburgh Sleep Quality Index (Score > 5 indicates poor sleep)	6 months
Secondary	Sleep timing	Derived from Activity Watches	6 months
Secondary	Subjective wellbeing	Visual Analogue Scales	6 months
Secondary	Salivary melatonin concentration	Circadian phase marker	6 months
Secondary	Pupil size	Pupil response to chromatic light stimuli	6 months
Secondary	Glucose metabolism	HbA1c concentration (blood)	6 months
Secondary	Telomere length	Age marker	6 months
Secondary	Neuropsychological Battery to assess working memory and attention (including n-back, Psychomotor Vigilance Test)	Cognitive Function	6 months