Validation of a Contactless Vital Signs Measurement Sensor

Sleep Apnea Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04676191
• Other study ID #: U1111-1248-9457
• Status: Completed
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: January 12, 2022

Study information

• Verified date: January 2022
• Source: Sleepiz AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 12, 2022
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• Sleepiz One+
Simultaneous sleep study with polysomnography and Sleepiz One+
• Polysomnography
Simultaneous sleep study with polysomnography and Sleepiz One+

Locations

Country	Name	City	State
Switzerland	Klinik Lengg AG	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Sleepiz AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiration rate measurement accuracy agreement		60 seconds
Secondary	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
Secondary	Instantaneous respiration rate agreement between Sleepiz One+ and nasal cannula		60 seconds
Secondary	Average respiration rate agreement between Sleepiz One+ and thoracic respiratory effort belt		1 Night
Secondary	Average respiration rate agreement between Sleepiz One+ and nasal cannula		1 Night
Secondary	Sleep/wake classification agreement between Sleepiz One+ compared to polysomnography (PSG) data manually scored by sleep technician		60 seconds