A Validation Study of the NightOwl Home Sleep Apnea Test

Sponsor

Ectosense NV (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04764734

Collaborator

(none)

100

Enrollment

Locations

Arm

9.4

Anticipated Duration (Months)

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea	Device: NightOwl	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea TestSingle Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea Test

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

A Validation Study of the NightOwl Home Sleep Apnea Test

Actual Study Start Date :

Mar 20, 2021

Anticipated Primary Completion Date :

Oct 30, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PSG and 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.	Device: NightOwl The NightOwl is a finger-mounted home sleep apnea testing device

Arm

Intervention/Treatment

Experimental: PSG and 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.

Device: NightOwl

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subjects with an indication for an in-lab polysomnography

Exclusion Criteria:

Intellectually disabled people

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coral Springs Laboratory	Coral Springs	Florida	United States	33071
2	United Sleep Diagnostics Hollywood Laboratory	Hollywood	Florida	United States	33021
3	Miami Lakes Laboratory	Miami Lakes	Florida	United States	33016
4	United Sleep Diagnostics Pembroke Pines Laboratory	Pembroke Pines	Florida	United States	33024

Sponsors and Collaborators

Ectosense NV

Investigators

Principal Investigator: Jagdeep Bijwadia, MD MBA, SleepMed RX

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ectosense NV

ClinicalTrials.gov Identifier:

NCT04764734

Other Study ID Numbers:

NightOwl-02

First Posted:

Feb 21, 2021

Last Update Posted:

Sep 13, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Apnea

Sleep Apnea Syndromes

Study Results

No Results Posted as of Sep 13, 2021