Validation of a Contactless Vital Signs Measurement Sensor
NCT04676191 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2022-01-25
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.
Conditions
Interventions
- DEVICE
-
Sleepiz One+
Simultaneous sleep study with polysomnography and Sleepiz One+
- DEVICE
-
Polysomnography
Simultaneous sleep study with polysomnography and Sleepiz One+
Sponsors & Collaborators
-
Sleepiz AG
lead INDUSTRY
Principal Investigators
-
Bartosz Bujan, Dr. med. · Klinik Lengg, Zurich
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-10
- Primary Completion
- 2021-02-02
- Completion
- 2022-01-12
Countries
- Switzerland
Study Locations
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