A Validation Study of the NightOwl Home Sleep Apnea Test

Status unconfirmed · Not applicable

Conditions studied: Sleep Apnea

In brief

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 apnea hypopnea index (AHI) estimate, 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. This study will be performed in a sleep lab environment.

Key facts

Study ID

NCT04764734

Run by

Ectosense NV

People needed

100

Starts

2021-03-20

Expected to finish

2022-09-10

Last updated by the study team

2022-09-06

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects with an indication for an in-lab polysomnography

You may not qualify if…

• Intellectually disabled people

Where it is running

• Coral Springs Laboratory — Coral Springs, Florida, United States
• United Sleep Diagnostics Hollywood Laboratory — Hollywood, Florida, United States
• Miami Lakes Laboratory — Miami Lakes, Florida, United States
• United Sleep Diagnostics Pembroke Pines Laboratory — Pembroke Pines, Florida, United States

Full record on ClinicalTrials.gov

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