Contactless Detection of Sleep Apnea

Sleepiz AG116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

116

Conditions

Sleep Apnea

Interventions

Sleepiz One+ vs. polysomnographyDEVICE

Simultaneous sleep recording with polysomnography and Sleepiz One+ device

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Universitätsmedizin Essen Ruhrlandklinik

Essen, North Rhine-Westphalia, Germany

Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.