NCT04676191CompletedNot Applicable
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
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Sleepiz AG
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Respiration rate measurement accuracy agreement
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients with sleep disorders, cardiorespiratory or neuromuscular disorders
Experimental
Intervention: Sleepiz One+ (Device)
Patients with sleep disorders, cardiorespiratory or neuromuscular disorders
Experimental
Intervention: Polysomnography (Device)
Outcomes
Primary Outcomes
Respiration rate measurement accuracy agreement
Time Frame: 60 seconds
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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