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

Not Applicable

• Conditions: Sleep Apnea

• Registration Number: NCT03385187
• Lead Sponsor: Ectosense NV

Brief 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.

Study Timeline

• Study Start: 2017-06-29
• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2017-12-28
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21
• Primary Completion: 2019-09-15
• Study Completion: 2019-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Indication for a sleep study

Exclusion Criteria

• Mentally disabled people
• Known allergy to Plexiglas (PMMA) or other acrylates

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index (AHI)	At the time of the diagnostic night	Comparison of the AHI derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors

Secondary Outcome Measures

Name	Time	Method
Sleep-wake discrimination	At time of the diagnostic night	Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium