A Validation Study of the NightOwl Home Sleep Apnea Test

Sleep Apnea Clinical Trial

Official title:

A Validation Study of the NightOwl Home Sleep Apnea Test

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04764734
• Other study ID #: NightOwl-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 20, 2021
• Est. completion date: September 10, 2022

Study information

• Verified date: September 2022
• Source: Ectosense NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 10, 2022
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

Inclusion Criteria:

• Subjects with an indication for an in-lab polysomnography

Exclusion Criteria:

• Intellectually disabled people

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Ectosense NV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization	The evaluation of the level agreement (classification accuracy) between patient categorization (into sleep apnea severity categories) obtained by the NightOwl and those obtained by the PSG. This measure is calculated by dividing the number of participants on which both NightOwl and the PSG agree on the sleep apnea severity category by the total number of participants.	Through study completion, an average of 1 month.