Sleep DisturbanceCIELNCT05485415
Intervention Study in Elderly With Sleep Problems
A study testing Multimodal intervention in people with Sleep Disturbance, run by Mirjam Münch at 1 site in Switzerland.
Trial 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 more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Multimodal intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jul 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Centre for Chronobiology, Psychiatric Hopspital of the University of Basel
Basel, 4002
About this study
Official title: Personalised Circadian 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.
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.
- Conditions
- Sleep Disturbance
- Being tested
- Multimodal intervention, Control
- Keywords
- circadian, light, cognition, Zeitgeber, personalized, health, sleep, muliti-modal
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal interventionBehavioural
Participants in the intervention group will receive personalised advice on sleep, light exposure, meal times and physical activity.
ControlBehavioural
General sleep advice
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Personalised intervention Receives: Behavioral: Multimodal intervention |
| Control | Placebo comparator | General sleep advice Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective sleep quality
Pittsburgh Sleep Quality Index (Score > 5 indicates poor sleep)
Measured: 6 months
Secondary outcomes (7)
Sleep timing
Derived from Activity Watches
Measured: 6 months
Subjective wellbeing
Visual Analogue Scales
Measured: 6 months
Salivary melatonin concentration
Circadian phase marker
Measured: 6 months
Pupil size
Pupil response to chromatic light stimuli
Measured: 6 months
Glucose metabolism
HbA1c concentration (blood)
Measured: 6 months
Telomere length
Age marker
Measured: 6 months
Neuropsychological Battery to assess working memory and attention (including n-back, Psychomotor Vigilance Test)
Cognitive Function
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start15 Jul 2022
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial with a control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirjam Münch
- Sponsor type
- Research network
- Collaborators
- University of California
- Responsible party
- Sponsor-investigator, Mirjam Münch, University Psychiatric Clinics Basel
- Investigators
- Mirjam Münch, PhD, Principal investigator, Research Associate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485415
- Sponsor's protocol ID
- 2022-00904
- Acronym
- CIEL
- Status last verified
- Mar 2025
- First submitted
- 14 Jun 2022
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Circadian Intervention Study in Elderly With Sleep Problems
- ClinicalTrials.gov ID
- NCT05485415
- Acronym / sponsor ID
- CIEL / 2022-00904
- Conditions
- Sleep Disturbance
- Keywords
- circadian, light, cognition, Zeitgeber, personalized, health, sleep, muliti-modal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mirjam MünchResearch network
- Collaborators
- University of California
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial with a control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Multimodal interventionPersonalised intervention |
| Control | Placebo comparator | Behavioral: ControlGeneral sleep advice |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- Total blindness or VA < 0.5
- Progressive NCDs (e.g., cancer)
- Acute infections (e.g., Covid-19)
- Neurodegenerative disease
- Psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal interventionParticipants in the intervention group will receive personalised advice on sleep, light exposure, meal times and physical activity. | Behavioural | Intervention |
| ControlGeneral sleep advice | Behavioural | Control |
Primary outcome
Subjective sleep quality
Time frame: 6 months
Pittsburgh Sleep Quality Index (Score > 5 indicates poor sleep)
7 secondary outcomes
Sleep timing
Time frame: 6 months
Subjective wellbeing
Time frame: 6 months
Salivary melatonin concentration
Time frame: 6 months
Pupil size
Time frame: 6 months
Glucose metabolism
Time frame: 6 months
Telomere length
Time frame: 6 months
Neuropsychological Battery to assess working memory and attention (including n-back, Psychomotor Vigilance Test)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirjam Münch, PhD principal investigator
Research Associate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal intervention in people with Sleep Disturbance, run by Mirjam Münch at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective sleep quality (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.