Cerebral Blood Flow and Ventilatory Responses During Sleep in Normoxia and Intermittent Hypoxia
NCT03255408
Apnea, Blood Pressure
Calgary, Alberta, Canada
View Trial DetailsNCT Number: NCT06093633
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.
Interested in participating?
Request Info12 year–99 year
All sexes
Observational
Tel-Aviv Medical Center, Tel Aviv, Israel
Subjects suspected of having sleep disorders who are referred to a sleep study will be screened for potential participation in the study, according to the inclusion and exclusion criteria. Additionally, patients with comorbidities associated with central sleep apnea may be referred from cardiology related divisions, and screened for participation in the study. Recruited patients will be asked to sign an informed consent form. Subject demographic and medical information will be acquired from the subject himself and/or from the subject's medical chart and will be recorded on the appropriate case report forms.
The subjects will be admitted to the clinical sleep laboratory for one night, during which they will undergo conventional full night PSG recording with the standard PSG channels. The WP with finger probe and chest sensor will be worn by the subject simultaneous to PSG. A PSG system will be recording the signals and manual scoring will be performed blinded - without access to WP data. The WP analysis will be done automatically.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: one night of sleep
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
Time frame: one night of sleep
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.
Time frame: one night of sleep
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
Contact information is provided by the study sponsor or research team.
Itamar-Medical, Israel
Industry
A Prospective Study to Evaluate the WatchPAT in Comparison to Polysomnography (PSG) Gold Standard in Patients Suspected of Sleep Disorders
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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