Sleep Apnea
Conditions
Keywords
respiration, sleep
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.
Interventions
DEVICESleepiz One+
Simultaneous sleep study with polysomnography and Sleepiz One+
DEVICEPolysomnography
Simultaneous sleep study with polysomnography and Sleepiz One+
Sponsors
Sleepiz AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiration rate measurement accuracy agreement | 60 seconds |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Switzerland
Outcome results
None listed