A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test

Status Completed

Clinical Trial Summary

Clinical Trial Description

The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software. The sensor acquires accelerometer and photoplethysmographic data. The software derives actigraphy from the former, and blood oxygen saturation and peripheral arterial tone (PAT), among other features, from the latter. In order to assess NightOwl's performance, The investigators will compare the respiratory event index (REI), defined as the number of respiratory events per hour of sleep, derived by the NightOwl system, to the AHI obtained from manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. The investigators will also compare the total sleep time (TST) derived by both systems. This study will be performed in a sleep lab environment. As of March 2017, the new clinical practice guideline for diagnostic testing for adult sleep apnea of the American Academy of Sleep Medicine (AASM) for the first time formulates a strong recommendation that both polysomnography (PSG) and home sleep apnea testing (HSAT) are appropriate diagnostic testing options for uncomplicated adult patients who are at increased risk of moderate to severe sleep apnea. Collop et al. performed a comprehensive analysis of the evidence for HSAT devices to diagnose obstructive sleep apnea (OSA) in out-of-center settings. The authors concluded that testing devices that analyze changes in peripheral arterial tone (PAT) in combination with actigraphy and blood oxygen saturation (SpO2) are adequate to diagnose OSA in patient populations with a high pre-test probability. In this study, the investigators wish to assess the performance of a system for the diagnosis of OSA that measures and analyzes the abovementioned parameters, called NightOwl. The system consists of a small sensor device which is placed on the fingertip and a cloud-based analytics platform. It is designed to be self-applied and initiated by the patient by attaching the sensor to the fingertip by means of an adhesive patch. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04191668
Study type	Interventional
Source	Ectosense NV
Contact
Status	Completed
Phase	N/A
Start date	December 2, 2019
Completion date	February 1, 2020

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