Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test

Not Applicable

• Conditions: Sleep Apnea

• Registration Number: NCT03635918
• Lead Sponsor: Ectosense NV

Brief Summary

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

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

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-14
• Study Start: 2018-08-15
• Study First Submitted QC: 2018-08-15
• Last Update Submitted: 2018-08-15
• Study First Posted: 2018-08-17
• Last Update Posted: 2018-08-17
• Primary Completion: 2019-09-15
• Study Completion: 2019-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• indication for a sleep study

Exclusion Criteria

• Mentally disabled people

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index (AHI)	For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software	Comparison of the AHI derived from the NightOwl HSAT to that of the benchmark PSG and HSAT monitors.

Secondary Outcome Measures

Name	Time	Method
Sleep-wake discrimination	For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software	Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the benchmark PSG and HSAT monitors.

Trial Locations

Locations (1)

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