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OpenTrials
Completed

NCT Number: NCT05485415

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Chronobiology, Psychiatric Hopspital of the University of Basel

Basel, 4002, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal Intervention

Behavioral

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

Control

Behavioral

General sleep advice

Primary outcomes

  1. Subjective sleep quality

    Time frame: 6 months

    Pittsburgh Sleep Quality Index (Score > 5 indicates poor sleep)

Secondary outcomes

  1. Sleep timing

    Time frame: 6 months

    Derived from Activity Watches

  2. Subjective wellbeing

    Time frame: 6 months

    Visual Analogue Scales

  3. Salivary melatonin concentration

    Time frame: 6 months

    Circadian phase marker

  4. Pupil size

    Time frame: 6 months

    Pupil response to chromatic light stimuli

  5. Glucose metabolism

    Time frame: 6 months

    HbA1c concentration (blood)

  6. Telomere length

    Time frame: 6 months

    Age marker

  7. Neuropsychological Battery to assess working memory and attention (including n-back, Psychomotor Vigilance Test)

    Time frame: 6 months

    Cognitive Function

Sponsors and collaborators

Lead sponsor

Mirjam Münch

Network

Collaborators

  • University of California

Registry information

Official study title

Personalised Circadian Intervention Study in Elderly With Sleep Problems

Acronym: CIEL

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 3, 2022
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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