Intervention Study in Elderly with Sleep Problems (CIEL)

Mirjam Münch

Status: Active, not recruiting

Conditions: Sleep Disturbance

Treatments: Behavioral: Control; Behavioral: Multimodal intervention

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05485415

2022-00904

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

66 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

Personalised intervention

Treatment:

Behavioral: Multimodal intervention

Control

Placebo Comparator group

Description:

General sleep advice

Treatment:

Behavioral: Control