A Validation Study of the NightOwl Home Sleep Apnea Test

Not Applicable

Active, not recruiting

• Conditions: Sleep Apnea
• Interventions: Device: NightOwl

• Registration Number: NCT04764734
• Lead Sponsor: Ectosense NV

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-18
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Study Start: 2021-03-20
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-02
• Primary Completion: 2022-09-05
• Last Update Posted: 2022-09-06
• Study Completion: 2022-09-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Subjects with an indication for an in-lab polysomnography

Exclusion Criteria

• Intellectually disabled people

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PSG and NightOwl	NightOwl	During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with the informed consent form. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.

Primary Outcome Measures

Name	Time	Method
The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization	Through study completion, an average of 1 month.	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.

Trial Locations

Locations (4)

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