CClinicalTrials.gg
CompletedNCT05485415CIELUpdated Jul 16, 2026

Intervention Study in Elderly With Sleep Problems

An interventional study of Multimodal intervention and Control in Sleep Disturbance, sponsored by Mirjam Münch. Completed at 1 site in Switzerland. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Mirjam Münch · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sleep Disturbance

Browse trials for

Keywords

  • circadian
  • light
  • cognition
  • Zeitgeber
  • personalized
  • health
  • sleep
  • muliti-modal
03

In context

Parasomnias

756 studies on the registry are indexed under Parasomnias; 189 are open to participants now.

This study's enrollment of 66 is close to the median of 66 across 569 interventional studies indexed under Parasomnias.

Browse Parasomnias studies →

Lead sponsor

This is the only study on the registry with Mirjam Münch as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
66 participants (actual)

Study arms

  • Active comparator
    Intervention

    Personalised intervention

    Behavioral: Multimodal intervention

  • Placebo comparator
    Control

    General sleep advice

    Behavioral: Control

Interventions

  • BehavioralMultimodal intervention

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

  • BehavioralControl

    General sleep advice

06

What researchers measure

Primary outcomes

  1. Subjective sleep quality

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

    Time frame: 6 months

Secondary outcomes

  1. Sleep timing

    Derived from Activity Watches

    Time frame: 6 months

  2. Subjective wellbeing

    Visual Analogue Scales

    Time frame: 6 months

  3. Salivary melatonin concentration

    Circadian phase marker

    Time frame: 6 months

  4. Pupil size

    Pupil response to chromatic light stimuli

    Time frame: 6 months

  5. Glucose metabolism

    HbA1c concentration (blood)

    Time frame: 6 months

  6. Telomere length

    Age marker

    Time frame: 6 months

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

    Cognitive Function

    Time frame: 6 months

07

Study locations

1 site
  • Centre for Chronobiology, Psychiatric Hopspital of the University of Basel
    Basel, 4002, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05485415
Lead sponsor
Mirjam Münch
Collaborators
University of California
Responsible party
Mirjam Münch (Principal Investigator, University Psychiatric Clinics Basel) — Sponsor-investigator
First posted
Aug 3, 2022
Start date
Jul 15, 2022
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025
Last update
Jul 16, 2026

Study contacts

Mirjam Münch, PhD
principal investigator · Research Associate

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion