Sleep Detection in Residents of Long-term Care Facilities

Sleep Detection in Older Adults Living in Long-term Care Facilities: An Inter-rater Reliability Agreement Study

Sleep disorders are common among older people. People who suffer from sleep disorders typically have difficulty falling asleep, staying asleep, wake up early and do not get restful sleep.

Research on sleep disorders in humans is already underway. Previous research projects in humans have shown that sleep disorders have an impact on bodily functions and quality of life. Disruptions to the sleep-wake cycle can also affect memory. Previous research projects have examined the measurement differences between polysomnography, an overnight sleep measurement in a sleep laboratory, which is currently the gold standard, and various contactless sleep sensor systems. The measurement differences are minor to moderate. However, we do not yet know how large the difference is between different days when using contactless sleep sensor systems in order to determine the accuracy of such devices for residents in retirement and nursing homes.

In this research project, we are therefore investigating sleep variability over a period of 14 days in 52 residents of retirement and nursing homes in Switzerland in order to be able to assess the smallest detectable difference in sleep quality.

We are conducting this research project in accordance with Swiss law. We also comply with all internationally recognized guidelines. The responsible ethics committee has reviewed and approved the research project.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Insomnia is a common sleep problem among older adults, with an overall prevalence reported between 30% and 50% and an even higher value among those living in nursing homes. Symptoms such as difficulty in falling asleep, difficulty in maintaining sleep, early morning awakening and non-restorative sleep not only have an important impact on the functional status and quality of life in older adults, but disturbances of the sleep-wake cycle are also known to be associated with cognitive decline. Polysomnography (PSG) is the current gold standard measuring for sleep disturbances using a collection of surface electrodes, physiologic an sleep parameters (including brain dynamics of electroencephalography (EEG)) in a sleep laboratory overnight. However, a 24-hour sleep detection based on objective measurement in older adults is of importance because excessive daytime sleepiness, and excessive napping are associated with negative health outcomes such as accelerated cognitive decline. Furthermore, Canadian 24-hours movement guidelines recommend to detect movement behavior, with sleep as a movement behavior included, over a 24-hour time span. Contactless sleep technologies (CSTs) may offer a low-burden and feasible assessment to monitoring sleep over 24-hours in older adults. To date there are several CSTs available with differences in accuracy compared to PSG. However, little is known regarding smallest detectable difference based on test-retest analysis based on intraday variability to effectively test the accuracy of such devices in older adults living in long-term care facilities. The objective of this study is to evaluate the smallest detectable difference of sleep quality based on test-retest analysis of two CSTs: (i) the Withings Sleep Analyzer and (ii) the Sleepiz One+ hardware in older adults.

Study Type

Observational

Enrollment (Estimated)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • St.Gallen
      • Sankt Gallen, St.Gallen, Switzerland, 9001
        • Recruiting
        • Easternswiss University of Applied Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Older Adults living in long-term care facilities without any neurocognitive disorder

Description

Inclusion Criteria:

  • Signed informed consent
  • Older adults living in the long-term care facilities

Exclusion Criteria:

  • Neurocognitive disorders based on Alzheimer's Disease, Parkinson's disease, Lewy body dementia or Mixed dementia according to patient record

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
residents of long-term care facilities without any neurocognitive disorders
residents of long-term care facilities without any neurocognitive disorders according to patient record

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Sleep Time
Time Frame: From enrollment to 14 days after
The time a person lying in bed actually sleeping
From enrollment to 14 days after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eling D de Bruin, Prof. Dr., Eastern Swiss University of Applied Sciences, ETH Zruich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

September 9, 2026

First Submitted That Met QC Criteria

September 9, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • SleepDetection
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-00629 (Registry Identifier: Eastern Swiss Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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