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Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test

Primary Purpose

Sleep Apnea

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

NightOwl HSAT

About this trial

This is an interventional diagnostic trial for Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Indication for a sleep study

Exclusion Criteria:

Mentally disabled people
Known allergy to Plexiglas (PMMA) or other acrylates

Sites / Locations

Ziekenhuis Oost-LimburgRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

NightOwl HSAT

Arm Description

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

Outcomes

Primary Outcome Measures

Apnea-Hypopnea Index (AHI)

Comparison of the AHI derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors

Secondary Outcome Measures

Sleep-wake discrimination

Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors

Full Information

NCT ID

NCT03385187

First Posted

December 20, 2017

Last Updated

March 19, 2019

Sponsor

Ectosense NV

Collaborators

Ziekenhuis Oost-Limburg

1. Study Identification

Unique Protocol Identification Number

NCT03385187

Brief Title

Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test

Official Title

Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 29, 2017 (Actual)

Primary Completion Date

September 15, 2019 (Anticipated)

Study Completion Date

December 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ectosense NV

Collaborators

Ziekenhuis Oost-Limburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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 Type IV sleep monitor will additionally be applied for comparison of its automated AHI derivation to that of the NightOwl.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NightOwl HSAT

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

NightOwl HSAT

Intervention Description

Patient wears the NightOwl sensor device

Primary Outcome Measure Information:

Title

Apnea-Hypopnea Index (AHI)

Description

Comparison of the AHI derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors

Time Frame

At the time of the diagnostic night

Secondary Outcome Measure Information:

Title

Sleep-wake discrimination

Description

Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors

Time Frame

At time of the diagnostic night

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Indication for a sleep study Exclusion Criteria: Mentally disabled people Known allergy to Plexiglas (PMMA) or other acrylates

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Duarte Mendes de Almeida, Ir.

Phone

+32 468 17 27 89

d.mdealmeida@ectosense.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Duarte Mendes de Almeida, Ir.

Organizational Affiliation

Ectosense NV

Official's Role

Study Director

Facility Information:

Facility Name

Ziekenhuis Oost-Limburg

City

Genk

State/Province

Limburg

ZIP/Postal Code

3600

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Inge Thijs, PhD

Phone

089 32 15 55

Ext

+32

Inge.Thijs@zol.be

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test

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