CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
NightOwldevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04191668
NCT04191668N/ACompleted

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

Ectosense NV·interventional·Posted Dec 10, 2019·Updated Mar 30, 2021

In Brief

A clinical study evaluating NightOwl for Sleep Apnea. Completed, enrolled 106 participants across 3 sites.

Detailed Summary

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 apnea-hypopnea index (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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedDec 10, 2019
Enrollment StartDec 2, 2019
Primary CompletionFeb 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.6 years ago

Interventions

NightOwldevice

The NightOwl is a finger-mounted home sleep apnea testing device