Contactless Detection of Sleep Apnea
Validation of a Contactless Sensor for Sleep Apnea Diagnosis Against Polysomnography
1 other identifier
interventional
116
1 country
1
Brief Summary
In this study the inestigators aim to validate the performance of Sleepiz One+ for sleep apnea detection during routine diagnostic sleep studies. Patients who are prescribed polysomnography study will be asked to participate and undergo a simultaneous sleep recording with radar sensor-based device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2020
CompletedFirst Submitted
Initial submission to the registry
December 9, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2021
CompletedJanuary 25, 2022
January 1, 2022
1 year
December 9, 2020
January 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Binary classification of subjects based on their sleep apnea severity (AHI ≥= 15) made by Sleepiz One+, compared to PSG data manually scored by sleep technicians
1 Night
Study Arms (2)
Patients suspected of suffering from sleep apnea
EXPERIMENTALHealthy volunteers
EXPERIMENTALInterventions
Simultaneous sleep recording with polysomnography and Sleepiz One+ device
Eligibility Criteria
You may qualify if:
- Age \>18years
- Ability and consent to undergo electrophysiological routine assessment
- Patients suspected to suffer from sleep apnea or any other sleep related disorder
You may not qualify if:
- Previous enrollment into the current study,
- Enrollment of the investigator, his/her family members and other dependent persons
- Cardiac pacemaker or another implanted electrical device
- Women who are pregnant or breastfeeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sleepiz AGlead
Study Sites (1)
Universitätsmedizin Essen Ruhrlandklinik
Essen, North Rhine-Westphalia, 45239, Germany
Related Publications (1)
Gross-Isselmann JA, Eggert T, Wildenauer A, Dietz-Terjung S, Grosse Sundrup M, Schoebel C. Validation of the Sleepiz One + as a radar-based sensor for contactless diagnosis of sleep apnea. Sleep Breath. 2024 Aug;28(4):1691-1699. doi: 10.1007/s11325-024-03057-6. Epub 2024 May 14.
PMID: 38744804DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Schöbel, Prof. Dr. med.
Universitätsmedizin Essen Ruhrlandklinik
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2020
First Posted
December 17, 2020
Study Start
December 7, 2020
Primary Completion
December 21, 2021
Study Completion
December 21, 2021
Last Updated
January 25, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share