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OpenTrials
Completed

NCT Number: NCT04676191

Validation of a Contactless Vital Signs Measurement Sensor

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.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik Lengg AG

Zurich, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleepiz One+

Device

Simultaneous sleep study with polysomnography and Sleepiz One+

Polysomnography

Device

Simultaneous sleep study with polysomnography and Sleepiz One+

Primary outcomes

  1. Respiration rate measurement accuracy agreement

    Time frame: 60 seconds

Secondary outcomes

  1. 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

    Time frame: 1 Night

  2. Instantaneous respiration rate agreement between Sleepiz One+ and nasal cannula

    Time frame: 60 seconds

  3. Average respiration rate agreement between Sleepiz One+ and thoracic respiratory effort belt

    Time frame: 1 Night

  4. Average respiration rate agreement between Sleepiz One+ and nasal cannula

    Time frame: 1 Night

  5. Sleep/wake classification agreement between Sleepiz One+ compared to polysomnography (PSG) data manually scored by sleep technician

    Time frame: 60 seconds

Sponsors and collaborators

Lead sponsor

Sleepiz AG

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 19, 2020
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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