Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test

NCT ID: NCT03635918

Last Updated: 2018-08-17

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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2019-09-15

Brief Summary

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Extensive Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to traditional PSG and HSAT monitors.

Detailed Description

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The purpose of this prospective validation study is the evaluation of the accuracy of the NightOwl HSAT to derive parameters relevant for the diagnosis of sleep apnea. The NightOwl HSAT comprises a finger or forehead mounted sensor and an automated analytics software. The sensor measures double-wavelength photo-plethysmography and accelerometry. The analytics software automatically interprets the sensor data and derives a measure of sympathetic activation of the autonomic nervous system, oxygen saturation, instantaneous pulse rate and activity. For each patient in the cohort, the AHI derived by the NightOwl will be compared to that of the Type I sleep monitor (in-lab PSG), which will acquire data simultaneously during the diagnostic night of the patient referred to the sleep lab for a polysomnography. On a randomly selected subset of patients, a benchmark HSAT will additionally be applied for comparison of its automated AHI derivation to that of the NightOwl.

Conditions

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Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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NightOwl HSAT

Patient undergoes a NightOwl sleep apnea test whilst simultaneously undergoing a sleep study with a Type I sleep monitor (Lab-PSG) and optionally a benchmark HSAT monitor.

Group Type OTHER

NightOwl HSAT

Intervention Type DEVICE

Patient wears the NightOwl sensor device

Interventions

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NightOwl HSAT

Patient wears the NightOwl sensor device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* indication for a sleep study

Exclusion Criteria

* Mentally disabled people
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ziekenhuis Oost-Limburg

OTHER

Sponsor Role collaborator

Ectosense NV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frederik Massie, ir.

Role: STUDY_DIRECTOR

Ectosense NV

Locations

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Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Frederik Massie, ir.

Role: CONTACT

474942710 ext. +32

Facility Contacts

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Inge Thijs, PhD

Role: primary

089 32 15 55 ext. +32

Other Identifiers

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17/034-11/06/2018

Identifier Type: -

Identifier Source: org_study_id

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