Validation of a Contactless Vital Signs Measurement Sensor

Not Applicable

Completed

• Conditions: Sleep Apnea

• Registration Number: NCT04676191
• Lead Sponsor: Sleepiz AG

Brief Summary

The primary aim of this study is to validate the performance of Sleepiz One+ for the measurement of vital physiological parameters in adult population, against a laboratory-based polysomnography. Additionally, the investigators will evaluate Sleepiz One+ ability to identify patients with a high risk of suffering from a sleep-related breathing disorder based on apnea-hypopnea index estimation. Participants will undergo measurement with Sleepiz One+ and a polysomnography device while resting in bed for 20 min as well as during sleep for the duration of the following night.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-10
• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-15
• Study First Posted: 2020-12-19
• Primary Completion: 2021-02-02
• Status Verified: 2022-01
• Study Completion: 2022-01-12
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Age >18years
• Ability and consent to undergo electrophysiological routine assessment
• Informed Consent as documented by signature
• Patients diagnosed or suspected to suffer from sleep apnea or any other sleep related disorder or patients suffering from chronic cardiac, respiratory or neuromuscular disorders
• Ambulatory or stationary patients of Klinik Lengg

Exclusion Criteria

• Previous enrolment into the current study,
• Enrolment of the investigator, his/her family members, employees and other dependent persons
• Cardiac pacemaker or another implanted electrical device
• Women who are pregnant
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Respiration rate measurement accuracy agreement	60 seconds

Secondary Outcome Measures

Name	Time	Method
Binary classification of sleep apnea severity based on the AHI > 15 of Sleepiz One+ compared to results of Domino software and data manually scored by sleep technician	1 Night
Average respiration rate agreement between Sleepiz One+ and nasal cannula	1 Night
Sleep/wake classification agreement between Sleepiz One+ compared to polysomnography (PSG) data manually scored by sleep technician	60 seconds
Average respiration rate agreement between Sleepiz One+ and thoracic respiratory effort belt	1 Night
Instantaneous respiration rate agreement between Sleepiz One+ and nasal cannula	60 seconds

Trial Locations

Locations (1)

Klinik Lengg AG; 🇨🇭 Zurich, Switzerland