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Search / Trial NCT04191668

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

Launched by ECTOSENSE NV · Dec 9, 2019

Trial Information

Current as of August 11, 2025

Completed

Keywords

ClinConnect 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, d...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Subjects with an indication for an in-lab polysomnography
  • Exclusion Criteria:
  • Intellectually disabled people
  • People younger than 13 years of age.

About Ectosense Nv

Ectosense NV is a pioneering medical technology company dedicated to advancing sleep health through innovative diagnostic solutions. With a focus on developing non-invasive monitoring devices, Ectosense aims to empower patients and healthcare providers with accurate and actionable insights into sleep disorders, particularly obstructive sleep apnea. By leveraging cutting-edge technology and clinical research, the company strives to enhance patient outcomes and improve the overall management of sleep-related conditions, positioning itself as a leader in the field of sleep medicine.

Locations

Miami Lakes, Florida, United States

Plantation, Florida, United States

Plantation, Florida, United States

Patients applied

0 patients applied

Trial Officials

Frederik Massie, MSc

Study Director

Ectosense NV

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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