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Intervention Study in Elderly With Sleep Problems (CIEL)

Primary Purpose

Sleep Disturbance

Status

Recruiting

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Multimodal intervention

Control

About this trial

This is an interventional other trial for Sleep Disturbance focused on measuring circadian, light, cognition, Zeitgeber, personalized, health, sleep, muliti-modal

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

> 64 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

Sites / Locations

Centre for Chronobiology, Psychiatric Hospital of the University of BaselRecruiting
Centre for Chronobiology, Psychiatric Hopspital of the University of BaselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Personalised intervention

General sleep advice

Outcomes

Primary Outcome Measures

Subjective sleep quality

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

Secondary Outcome Measures

Sleep timing

Derived from Activity Watches

Subjective wellbeing

Visual Analogue Scales

Salivary melatonin concentration

Circadian phase marker

Pupil size

Pupil response to chromatic light stimuli

Glucose metabolism

HbA1c concentration (blood)

Telomere length

Age marker

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

Cognitive Function

Full Information

NCT ID

NCT05485415

First Posted

June 14, 2022

Last Updated

September 1, 2023

Sponsor

Mirjam Münch

Collaborators

University of California

1. Study Identification

Unique Protocol Identification Number

NCT05485415

Brief Title

Intervention Study in Elderly With Sleep Problems

Acronym

CIEL

Official Title

Personalised Circadian Intervention Study in Elderly With Sleep Problems

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 15, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mirjam Münch

Collaborators

University of California

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disturbance

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized Clinical Trial with a control group

Masking

Participant

Masking Description

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

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Active Comparator

Arm Description

Personalised intervention

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

General sleep advice

Intervention Type

Behavioral

Intervention Name(s)

Multimodal intervention

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Control

Intervention Description

General sleep advice

Primary Outcome Measure Information:

Title

Subjective sleep quality

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Sleep timing

Description

Derived from Activity Watches

Time Frame

6 months

Title

Subjective wellbeing

Description

Visual Analogue Scales

Time Frame

6 months

Title

Salivary melatonin concentration

Description

Circadian phase marker

Time Frame

6 months

Title

Pupil size

Description

Pupil response to chromatic light stimuli

Time Frame

6 months

Title

Glucose metabolism

Description

HbA1c concentration (blood)

Time Frame

6 months

Title

Telomere length

Description

Age marker

Time Frame

6 months

Title

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

Description

Cognitive Function

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: > 64 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mirjam Münch, PhD

Phone

+41 61 325 2358

mirjam.muench@unibas.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mirjam Münch, PhD

Organizational Affiliation

Research Associate

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre for Chronobiology, Psychiatric Hospital of the University of Basel

City

Basel

State/Province

ZIP/Postal Code

4002

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mirjam Münch, PhD

Phone

+41613255328

mirjam.muench@unibas.ch

First Name & Middle Initial & Last Name & Degree

Sophie Reckels, MSc

Phone

+41613255313

sophie.reckels@unibas.ch

First Name & Middle Initial & Last Name & Degree

Johanna Otte, MSc

Facility Name

Centre for Chronobiology, Psychiatric Hopspital of the University of Basel

City

Basel

ZIP/Postal Code

4002

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sophie Reckels, MSc

Phone

+41 61 325 53 13

sophie.reckels@unibas.ch

First Name & Middle Initial & Last Name & Degree

Johanna Otte, MSc

Phone

+41 61 325 53 13

johanna.otte@unibas.ch

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Intervention Study in Elderly With Sleep Problems

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