NCT04764734

A Validation Study of the NightOwl Home Sleep Apnea Test

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ectosense NV · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Sleep Apnea

Interventions

Type	Name	Description
DEVICE	NightOwl	The NightOwl is a finger-mounted home sleep apnea testing device

Timeline

• Start date: 2021-03-20
• Primary completion: 2022-09-05
• Completion: 2022-09-10
• First posted: 2021-02-21
• Last updated: 2022-09-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study