Contactless Detection of Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-07

Study Completion Date

2021-12-21

Brief Summary

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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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Detailed Description

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Conditions

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Sleep Apnea

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients suspected of suffering from sleep apnea

Group Type EXPERIMENTAL

Sleepiz One+ vs. polysomnography

Intervention Type DEVICE

Simultaneous sleep recording with polysomnography and Sleepiz One+ device

Healthy volunteers

Group Type EXPERIMENTAL

Sleepiz One+ vs. polysomnography

Intervention Type DEVICE

Simultaneous sleep recording with polysomnography and Sleepiz One+ device

Interventions

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Sleepiz One+ vs. polysomnography

Simultaneous sleep recording with polysomnography and Sleepiz One+ device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes