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

March 19, 2019 updated by: Ectosense NV
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Recruiting
        • Ziekenhuis Oost-Limburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indication for a sleep study

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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 Type IV sleep monitor.
Device: NightOwl HSAT
Patient wears the NightOwl sensor device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea Index (AHI)
Time Frame: At the time of the diagnostic night
Comparison of the AHI derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors
At the time of the diagnostic night

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep-wake discrimination
Time Frame: At time of the diagnostic night
Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors
At time of the diagnostic night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ectosense NV

Collaborators

Ziekenhuis Oost-Limburg

Investigators

  • Study Director: Duarte Mendes de Almeida, Ir., Ectosense NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 29, 2017

Primary Completion (ANTICIPATED)

September 15, 2019

Study Completion (ANTICIPATED)

December 15, 2019

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

December 27, 2017

First Posted (ACTUAL)

December 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17/034U

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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