Validation of a Contactless Vital Signs Measurement Sensor

NCT ID: NCT04676191

Last Updated: 2022-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-10

Study Completion Date

2022-01-12

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.

Detailed Description

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Conditions

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Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with sleep disorders, cardiorespiratory or neuromuscular disorders

Group Type EXPERIMENTAL

Sleepiz One+

Intervention Type DEVICE

Simultaneous sleep study with polysomnography and Sleepiz One+

Polysomnography

Intervention Type DEVICE

Simultaneous sleep study with polysomnography and Sleepiz One+

Interventions

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Sleepiz One+

Simultaneous sleep study with polysomnography and Sleepiz One+

Intervention Type DEVICE

Polysomnography

Simultaneous sleep study with polysomnography and Sleepiz One+

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sleepiz AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bartosz Bujan, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinik Lengg, Zurich

Locations

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Klinik Lengg AG

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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U1111-1248-9457

Identifier Type: -

Identifier Source: org_study_id

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