A Validation Study of the NightOwl Home Sleep Apnea Test

NCT ID: NCT04764734

Last Updated: 2022-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-20

Study Completion Date

2022-09-10

Brief Summary

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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

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Conditions

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Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

NightOwl

Intervention Type DEVICE

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

Interventions

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NightOwl

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects with an indication for an in-lab polysomnography

Exclusion Criteria

* Intellectually disabled people
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ectosense NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jagdeep Bijwadia, MD MBA

Role: PRINCIPAL_INVESTIGATOR

SleepMed RX

Locations

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Coral Springs Laboratory

Coral Springs, Florida, United States

Site Status

United Sleep Diagnostics Hollywood Laboratory

Hollywood, Florida, United States

Site Status

Miami Lakes Laboratory

Miami Lakes, Florida, United States

Site Status

United Sleep Diagnostics Pembroke Pines Laboratory

Pembroke Pines, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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NightOwl-02

Identifier Type: -

Identifier Source: org_study_id

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