About this trial
The current study is a prospective blinded study to collect data regarding the performance of the WP device in detecting sleep disorders. For that purpose, the WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG in a sleep study at the clinical sleep lab. A PSG system will be recording the PSG data.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 12-99
Subjects that are able to read understand and sign the informed consent form of the study or by parents of subjects that are less than 18 years of age that are referred to undergo an overnight sleep study in the clinical sleep laboratory
Subjects suspected of having sleep disorders or with comorbidities relevant to central sleep apnea.
Disqualifiers
Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
Finger deformity that precludes adequate sensor appliance.
Trial population
Subjects with suspected sleep disorders or patients with comorbidities that increase the likelihood of central sleep apnea who are referred for a sleep study.
Trial design
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Apnea- Hypopnea Index (AHI)
Compares the results of the automatically scored AHI of the WP to the manually scored AHI of the PSG (Gold Standard). AHI is the average number of apnea and hypopnea events per hour of sleep
Sleep Stages
Compares the results of the automatically scored sleep stages of the WP to the manually scored sleep stages of the PSG (Gold Standard). Stages are light sleep, deep sleep, REM or Wake.
Secondary outcomes
Respiratory Disturbance Index (RDI)
Compares the results of the automatically scored RDI of the WP to the manually scored RDI of the PSG (Gold Standard). RDI is the average number of respiratory events per hour of sleep
Sponsors and contacts
Click on the lead sponsor to view all of their trials.