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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04676191
Other study ID # U1111-1248-9457
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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