Validation of a Contactless Vital Signs Measurement Sensor

NCT04676191 | Completed

• 1 other identifier: U1111-1248-9457
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea

Keywords

respiration; sleep

Outcome Measures

Primary Outcomes (1)

• Respiration rate measurement accuracy agreement

  60 seconds

Secondary Outcomes (5)

• 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

Study Arms (1)

Patients with sleep disorders, cardiorespiratory or neuromuscular disorders

EXPERIMENTAL

Device: Sleepiz One+; Device: Polysomnography

Interventions

Sleepiz One+ DEVICE

Simultaneous sleep study with polysomnography and Sleepiz One+

Patients with sleep disorders, cardiorespiratory or neuromuscular disorders

Polysomnography DEVICE

Simultaneous sleep study with polysomnography and Sleepiz One+

Patients with sleep disorders, cardiorespiratory or neuromuscular disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sleepiz AG: lead

Study Sites (1)

Klinik Lengg AG

Zurich, Switzerland

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Respiratory Aspiration

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Bartosz Bujan, Dr. med.

  Klinik Lengg, Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 19, 2020
• Study Start: September 10, 2020
• Primary Completion: February 2, 2021
• Study Completion: January 12, 2022
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)