NCT03385187

Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Ectosense NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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 Type IV sleep monitor will additionally be applied for comparison of its automated AHI derivation to that of the NightOwl.

Conditions

• Sleep Apnea

Interventions

Type	Name	Description
DEVICE	NightOwl HSAT	Patient wears the NightOwl sensor device

Timeline

• Start date: 2017-06-29
• Primary completion: 2019-09-15
• Completion: 2019-12-15
• First posted: 2017-12-28
• Last updated: 2019-03-21

Locations

1 site across 1 country: Belgium