Validation of a Contactless Vital Signs Measurement Sensor

Study Overview
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Brief Summary
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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.

Official Title
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Single- Center Performance Assessment of a Contactless Sensor for Vital Physiological Parameters Measurement at Rest and Detection of Diagnostic Indices in Sleep Compared to Cardiorespiratory Polygraphy

Conditions
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Sleep Apnea

Intervention / Treatment
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* Device: Sleepiz One+
* Device: Polysomnography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with sleep disorders, cardiorespiratory or neuromuscular disorders<br> | Device: Sleepiz One+<br>* Simultaneous sleep study with polysomnography and Sleepiz One+<br>Device: Polysomnography<br>* Simultaneous sleep study with polysomnography and Sleepiz One+<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiration rate measurement accuracy agreement |  | 60 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Instantaneous respiration rate agreement between Sleepiz One+ and nasal cannula |  | 60 seconds | 
| Average respiration rate agreement between Sleepiz One+ and thoracic respiratory effort belt |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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respiration, sleep