Intervention Study in Elderly With Sleep Problems

Not Applicable

Active, not recruiting

• Conditions: Sleep Disturbance
• Interventions: Behavioral: Multimodal intervention; Behavioral: Control

• Registration Number: NCT05485415
• Lead Sponsor: Mirjam Münch

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.

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 Timeline

• Study First Submitted: 2022-06-14
• Study Start: 2022-07-15
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Multimodal intervention	Personalised intervention
Control	Control	General sleep advice

Primary Outcome Measures

Name	Time	Method
Subjective sleep quality	6 months	Pittsburgh Sleep Quality Index (Score \> 5 indicates poor sleep)

Secondary Outcome Measures

Name	Time	Method
Sleep timing	6 months	Derived from Activity Watches
Salivary melatonin concentration	6 months	Circadian phase marker
Neuropsychological Battery to assess working memory and attention (including n-back, Psychomotor Vigilance Test)	6 months	Cognitive Function
Pupil size	6 months	Pupil response to chromatic light stimuli
Glucose metabolism	6 months	HbA1c concentration (blood)
Telomere length	6 months	Age marker
Subjective wellbeing	6 months	Visual Analogue Scales

Trial Locations

Locations (1)

Centre for Chronobiology, Psychiatric Hopspital of the University of Basel; 🇨🇭 Basel, Switzerland