An interventional study of NightOwl HSAT in Sleep Apnea, sponsored by Ectosense NV. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-21.
Sponsored by Ectosense NV · Not applicable, Interventional, and Diagnostic
Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to a traditional Type I and a Type IV sleep monitor.
The purpose of this prospective validation study is the evaluation of the accuracy of the NightOwl HSAT to derive parameters relevant for the diagnosis of sleep apnea. The NightOwl HSAT comprises a finger or forehead mounted sensor and an automated analytics software. The sensor measures double-wavelength photo-plethysmography and accelerometry. The analytics software automatically interprets the sensor data and derives a measure of sympathetic activation of the autonomic nervous system, oxygen saturation, instantaneous pulse rate and activity. For each patient in the cohort, the AHI derived by the NightOwl will be compared to that of the Type I sleep monitor (in-lab PSG), which will acquire data simultaneously during the diagnostic night of the patient referred to the sleep lab for a polysomnography. On a randomly selected subset of patients, a Type IV sleep monitor will additionally be applied for comparison of its automated AHI derivation to that of the NightOwl.
Exclusion Criteria:
Patient undergoes a NightOwl sleep apnea test whilst simultaneously undergoing a sleep study with a Type I sleep monitor (Lab-PSG) and optionally a Type IV sleep monitor.
Device: NightOwl HSAT
Patient wears the NightOwl sensor device
Apnea-Hypopnea Index (AHI)
Comparison of the AHI derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors
Time frame: At the time of the diagnostic night
Sleep-wake discrimination
Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors
Time frame: At time of the diagnostic night
Plan to share: No
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Ectosense NV