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Clinical Trial Summary

Extensive Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to traditional PSG and HSAT monitors.


Clinical Trial Description

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 benchmark HSAT will additionally be applied for comparison of its automated AHI derivation to that of the NightOwl. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03635918
Study type Interventional
Source Ectosense NV
Contact Frederik Massie, ir.
Phone 474942710
Email frederik.massie@ectosense.com
Status Recruiting
Phase N/A
Start date August 15, 2018
Completion date September 15, 2019

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