Sleep DisturbanceNCT07819409
Sleep Detection in Residents of Long-term Care Facilities
An observational study of Sleep Disturbance, run by Eastern Switzerland University of Applied Sciences at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Aug 2025to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Older Adults living in long-term care facilities without any neurocognitive disorder
Who may be able to join
- Signed informed consent
- Older adults living in the long-term care facilities
Who cannot join
- Neurocognitive disorders based on Alzheimer's Disease, Parkinson's disease, Lewy body dementia or Mixed dementia according to patient record
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Easternswiss University of Applied Sciences
Sankt Gallen, St.Gallen, 9001
About this study
Official title: 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, the investigators 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.
Read more
In this research project, the investigator 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.
The investigators are conducting this research project in accordance with Swiss law. The investigators also comply with all internationally recognized guidelines. The responsible ethics committee has reviewed and approved the research project.
Read the 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.
- Conditions
- Sleep Disturbance
- Keywords
- sleep detection, residents of long-term care facilities, interrater agreement
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
The time a person lying in bed actually sleeping
Measured: From enrollment to 14 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start28 Aug 2025
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Switzerland University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eling D de Bruin, Prof. Dr., Principal investigator, Eastern Swiss University of Applied Sciences, ETH Zruich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819409
- Sponsor's protocol ID
- SleepDetection
- Other IDs
- 2025-00629, 2025
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee T, Cho Y, Cha KS, Jung J, Cho J, Kim H, Kim D, Hong J, Lee D, Keum M, Kushida CA, Yoon IY, Kim JW. Accuracy of 11 Wearable, Nearable, and Airable Consumer Sleep Trackers: Prospective Multicenter Validation Study. JMIR Mhealth Uhealth. 2023 Nov 2;11:e50983. doi: 10.2196/50983.
PubMed 37917155Oskarsdottir M, Islind AS, August E, Arnardottir ES, Patou F, Maier AM. Importance of Getting Enough Sleep and Daily Activity Data to Assess Variability: Longitudinal Observational Study. JMIR Form Res. 2022 Feb 22;6(2):e31807. doi: 10.2196/31807.
PubMed 35191850Perez-Pozuelo I, Zhai B, Palotti J, Mall R, Aupetit M, Garcia-Gomez JM, Taheri S, Guan Y, Fernandez-Luque L. The future of sleep health: a data-driven revolution in sleep science and medicine. NPJ Digit Med. 2020 Mar 23;3:42. doi: 10.1038/s41746-020-0244-4. eCollection 2020.
PubMed 32219183de Zambotti M, Menghini L, Grandner MA, Redline S, Zhang Y, Wallace ML, Buxton OM. Rigorous performance evaluation (previously, "validation") for informed use of new technologies for sleep health measurement. Sleep Health. 2022 Jun;8(3):263-269. doi: 10.1016/j.sleh.2022.02.006. Epub 2022 May 3.
PubMed 35513978G Ravindran KK, Della Monica C, Atzori G, Lambert D, Hassanin H, Revell V, Dijk DJ. Three Contactless Sleep Technologies Compared With Actigraphy and Polysomnography in a Heterogeneous Group of Older Men and Women in a Model of Mild Sleep Disturbance: Sleep Laboratory Study. JMIR Mhealth Uhealth. 2023 Oct 25;11:e46338. doi: 10.2196/46338.
PubMed 37878360Ross R, Chaput JP, Giangregorio LM, Janssen I, Saunders TJ, Kho ME, Poitras VJ, Tomasone JR, El-Kotob R, McLaughlin EC, Duggan M, Carrier J, Carson V, Chastin SF, Latimer-Cheung AE, Chulak-Bozzer T, Faulkner G, Flood SM, Gazendam MK, Healy GN, Katzmarzyk PT, Kennedy W, Lane KN, Lorbergs A, Maclaren K, Marr S, Powell KE, Rhodes RE, Ross-White A, Welsh F, Willumsen J, Tremblay MS. Canadian 24-Hour Movement Guidelines for Adults aged 18-64 years and Adults aged 65 years or older: an integration of physical activity, sedentary behaviour, and sleep. Appl Physiol Nutr Metab. 2020 Oct;45(10 (Suppl. 2)):S57-S102. doi: 10.1139/apnm-2020-0467.
PubMed 33054332Leng Y, Redline S, Stone KL, Ancoli-Israel S, Yaffe K. Objective napping, cognitive decline, and risk of cognitive impairment in older men. Alzheimers Dement. 2019 Aug;15(8):1039-1047. doi: 10.1016/j.jalz.2019.04.009. Epub 2019 Jun 18.
PubMed 31227429Owusu JT, Wennberg AMV, Holingue CB, Tzuang M, Abeson KD, Spira AP. Napping characteristics and cognitive performance in older adults. Int J Geriatr Psychiatry. 2019 Jan;34(1):87-96. doi: 10.1002/gps.4991. Epub 2018 Oct 12.
PubMed 30311961Li P, Gao L, Yu L, Zheng X, Ulsa MC, Yang HW, Gaba A, Yaffe K, Bennett DA, Buchman AS, Hu K, Leng Y. Daytime napping and Alzheimer's dementia: A potential bidirectional relationship. Alzheimers Dement. 2023 Jan;19(1):158-168. doi: 10.1002/alz.12636. Epub 2022 Mar 17.
PubMed 35297533Cross N, Terpening Z, Rogers NL, Duffy SL, Hickie IB, Lewis SJ, Naismith SL. Napping in older people 'at risk' of dementia: relationships with depression, cognition, medical burden and sleep quality. J Sleep Res. 2015 Oct;24(5):494-502. doi: 10.1111/jsr.12313. Epub 2015 Jun 21.
PubMed 26096839Marino M, Li Y, Rueschman MN, Winkelman JW, Ellenbogen JM, Solet JM, Dulin H, Berkman LF, Buxton OM. Measuring sleep: accuracy, sensitivity, and specificity of wrist actigraphy compared to polysomnography. Sleep. 2013 Nov 1;36(11):1747-55. doi: 10.5665/sleep.3142.
PubMed 24179309Winsky-Sommerer R, de Oliveira P, Loomis S, Wafford K, Dijk DJ, Gilmour G. Disturbances of sleep quality, timing and structure and their relationship with other neuropsychiatric symptoms in Alzheimer's disease and schizophrenia: Insights from studies in patient populations and animal models. Neurosci Biobehav Rev. 2019 Feb;97:112-137. doi: 10.1016/j.neubiorev.2018.09.027. Epub 2018 Oct 9.
PubMed 30312626Balouch S, Dijk DAD, Rusted J, Skene SS, Tabet N, Dijk DJ. Night-to-night variation in sleep associates with day-to-day variation in vigilance, cognition, memory, and behavioral problems in Alzheimer's disease. Alzheimers Dement (Amst). 2022 May 16;14(1):e12303. doi: 10.1002/dad2.12303. eCollection 2022.
PubMed 35603140Fung CH, Vitiello MV, Alessi CA, Kuchel GA; AGS/NIA Sleep Conference Planning Committee and Faculty. Report and Research Agenda of the American Geriatrics Society and National Institute on Aging Bedside-to-Bench Conference on Sleep, Circadian Rhythms, and Aging: New Avenues for Improving Brain Health, Physical Health, and Functioning. J Am Geriatr Soc. 2016 Dec;64(12):e238-e247. doi: 10.1111/jgs.14493. Epub 2016 Nov 14.
PubMed 27858974Ebben MR. Insomnia: Behavioral Treatment in the Elderly. Clin Geriatr Med. 2021 Aug;37(3):387-399. doi: 10.1016/j.cger.2021.04.002. Epub 2021 Jun 4.
PubMed 34210445
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Detection in Older Adults Living in Long-term Care Facilities: An Inter-rater Reliability Agreement Study
- ClinicalTrials.gov ID
- NCT07819409
- Acronym / sponsor ID
- SleepDetection
- Conditions
- Sleep Disturbance
- Keywords
- sleep detection, residents of long-term care facilities, interrater agreement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Eastern Switzerland University of Applied SciencesUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 14 Sep 2026 (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.
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, the investigators 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, the investigator 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.
The investigators are conducting this research project in accordance with Swiss law. The investigators also comply with all internationally recognized guidelines. The responsible ethics committee has reviewed and approved the research project.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| residents of long-term care facilities without any neurocognitive disorders | – | –residents of long-term care facilities without any neurocognitive disorders according to patient record |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Older Adults living in long-term care facilities without any neurocognitive disorder
Key inclusion criteria (2 listed)
- Signed informed consent
- Older adults living in the long-term care facilities
Key exclusion criteria (1 listed)
- Neurocognitive disorders based on Alzheimer's Disease, Parkinson's disease, Lewy body dementia or Mixed dementia according to patient record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Sleep Time
Time frame: From enrollment to 14 days after
The time a person lying in bed actually sleeping
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Results publication: PubMed 37917155Lee T, Cho Y, Cha KS, Jung J, Cho J, Kim H, Kim D, Hong J, Lee D, Keum M, Kushida CA, Yoon IY, Kim JW. Accuracy of 11 Wearable, Nearable, and Airable Consumer Sleep Trackers: Prospective Multicenter Validation Study. JMIR Mhealth Uhealth. 2023 Nov 2;11:e50983. doi: 10.2196/50983.
- Results publication: PubMed 35191850Oskarsdottir M, Islind AS, August E, Arnardottir ES, Patou F, Maier AM. Importance of Getting Enough Sleep and Daily Activity Data to Assess Variability: Longitudinal Observational Study. JMIR Form Res. 2022 Feb 22;6(2):e31807. doi: 10.2196/31807.
- Results publication: PubMed 32219183Perez-Pozuelo I, Zhai B, Palotti J, Mall R, Aupetit M, Garcia-Gomez JM, Taheri S, Guan Y, Fernandez-Luque L. The future of sleep health: a data-driven revolution in sleep science and medicine. NPJ Digit Med. 2020 Mar 23;3:42. doi: 10.1038/s41746-020-0244-4. eCollection 2020.
- Results publication: PubMed 35513978de Zambotti M, Menghini L, Grandner MA, Redline S, Zhang Y, Wallace ML, Buxton OM. Rigorous performance evaluation (previously, "validation") for informed use of new technologies for sleep health measurement. Sleep Health. 2022 Jun;8(3):263-269. doi: 10.1016/j.sleh.2022.02.006. Epub 2022 May 3.
- Results publication: PubMed 37878360G Ravindran KK, Della Monica C, Atzori G, Lambert D, Hassanin H, Revell V, Dijk DJ. Three Contactless Sleep Technologies Compared With Actigraphy and Polysomnography in a Heterogeneous Group of Older Men and Women in a Model of Mild Sleep Disturbance: Sleep Laboratory Study. JMIR Mhealth Uhealth. 2023 Oct 25;11:e46338. doi: 10.2196/46338.
- Results publication: PubMed 33054332Ross R, Chaput JP, Giangregorio LM, Janssen I, Saunders TJ, Kho ME, Poitras VJ, Tomasone JR, El-Kotob R, McLaughlin EC, Duggan M, Carrier J, Carson V, Chastin SF, Latimer-Cheung AE, Chulak-Bozzer T, Faulkner G, Flood SM, Gazendam MK, Healy GN, Katzmarzyk PT, Kennedy W, Lane KN, Lorbergs A, Maclaren K, Marr S, Powell KE, Rhodes RE, Ross-White A, Welsh F, Willumsen J, Tremblay MS. Canadian 24-Hour Movement Guidelines for Adults aged 18-64 years and Adults aged 65 years or older: an integration of physical activity, sedentary behaviour, and sleep. Appl Physiol Nutr Metab. 2020 Oct;45(10 (Suppl. 2)):S57-S102. doi: 10.1139/apnm-2020-0467.
- Results publication: PubMed 31227429Leng Y, Redline S, Stone KL, Ancoli-Israel S, Yaffe K. Objective napping, cognitive decline, and risk of cognitive impairment in older men. Alzheimers Dement. 2019 Aug;15(8):1039-1047. doi: 10.1016/j.jalz.2019.04.009. Epub 2019 Jun 18.
- Results publication: PubMed 30311961Owusu JT, Wennberg AMV, Holingue CB, Tzuang M, Abeson KD, Spira AP. Napping characteristics and cognitive performance in older adults. Int J Geriatr Psychiatry. 2019 Jan;34(1):87-96. doi: 10.1002/gps.4991. Epub 2018 Oct 12.
- Results publication: PubMed 35297533Li P, Gao L, Yu L, Zheng X, Ulsa MC, Yang HW, Gaba A, Yaffe K, Bennett DA, Buchman AS, Hu K, Leng Y. Daytime napping and Alzheimer's dementia: A potential bidirectional relationship. Alzheimers Dement. 2023 Jan;19(1):158-168. doi: 10.1002/alz.12636. Epub 2022 Mar 17.
- Results publication: PubMed 26096839Cross N, Terpening Z, Rogers NL, Duffy SL, Hickie IB, Lewis SJ, Naismith SL. Napping in older people 'at risk' of dementia: relationships with depression, cognition, medical burden and sleep quality. J Sleep Res. 2015 Oct;24(5):494-502. doi: 10.1111/jsr.12313. Epub 2015 Jun 21.
- Results publication: PubMed 24179309Marino M, Li Y, Rueschman MN, Winkelman JW, Ellenbogen JM, Solet JM, Dulin H, Berkman LF, Buxton OM. Measuring sleep: accuracy, sensitivity, and specificity of wrist actigraphy compared to polysomnography. Sleep. 2013 Nov 1;36(11):1747-55. doi: 10.5665/sleep.3142.
- Results publication: PubMed 30312626Winsky-Sommerer R, de Oliveira P, Loomis S, Wafford K, Dijk DJ, Gilmour G. Disturbances of sleep quality, timing and structure and their relationship with other neuropsychiatric symptoms in Alzheimer's disease and schizophrenia: Insights from studies in patient populations and animal models. Neurosci Biobehav Rev. 2019 Feb;97:112-137. doi: 10.1016/j.neubiorev.2018.09.027. Epub 2018 Oct 9.
- 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.
Eling D de Bruin, Prof. Dr. principal investigator
Eastern Swiss University of Applied Sciences, ETH Zruich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disturbance, run by Eastern Switzerland University of Applied Sciences 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Sep 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eling D de Bruin, Prof. Dr. (+41 58 257 14 11, eling.debruin@ost.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (time frame: From enrollment to 14 days after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07819409, which also lists 20 linked publications.
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 17 Sep 2026.