Contactless Detection of Sleep Apnea

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.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsmedizin Essen Ruhrlandklinik

Essen, North Rhine-Westphalia, 45239, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >18years
Ability and consent to undergo electrophysiological routine assessment
Patients suspected to suffer from sleep apnea or any other sleep related disorder

Exclusion criteria

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

Treatment and study plan

Sleepiz One+ vs. polysomnography

Device

Simultaneous sleep recording with polysomnography and Sleepiz One+ device

Primary outcomes

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

Time frame: 1 Night

Sponsors and collaborators

Lead sponsor

Sleepiz AG

Industry

Registry information

Official study title

Validation of a Contactless Sensor for Sleep Apnea Diagnosis Against Polysomnography

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Dec 17, 2020
Registry last updated: Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed