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Intervention Study in Elderly With Sleep Problems

Personalised Circadian Intervention Study in Elderly With Sleep Problems

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05485415
Acronym
CIEL
Enrollment
66
Registered
2022-08-03
Start date
2022-07-15
Completion date
2025-07-31
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disturbance

Keywords

circadian, light, cognition, Zeitgeber, personalized, health, sleep, muliti-modal

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.

Interventions

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

BEHAVIORALControl

General sleep advice

Sponsors

Mirjam Münch
Lead SponsorNETWORK
University of California
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

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

Intervention model description

Randomized Clinical Trial with a control group

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Subjective sleep quality6 monthsPittsburgh Sleep Quality Index (Score \> 5 indicates poor sleep)

Secondary

MeasureTime frameDescription
Sleep timing6 monthsDerived from Activity Watches
Subjective wellbeing6 monthsVisual Analogue Scales
Salivary melatonin concentration6 monthsCircadian phase marker
Pupil size6 monthsPupil response to chromatic light stimuli
Glucose metabolism6 monthsHbA1c concentration (blood)
Telomere length6 monthsAge marker
Neuropsychological Battery to assess working memory and attention (including n-back, Psychomotor Vigilance Test)6 monthsCognitive Function

Countries

Switzerland

Contacts

PRINCIPAL_INVESTIGATORMirjam Münch, PhD

Research Associate

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026