Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test

August 15, 2018 updated by: Ectosense NV
Extensive Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to traditional PSG and HSAT monitors.

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 benchmark HSAT will additionally be applied for comparison of its automated AHI derivation to that of the NightOwl.

Study Type

Interventional

Enrollment (Anticipated)

500

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 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • indication for a sleep study

Exclusion Criteria:

  • Mentally disabled people

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 benchmark HSAT 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: For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software
Comparison of the AHI derived from the NightOwl HSAT to that of the benchmark PSG and HSAT monitors.
For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep-wake discrimination
Time Frame: For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software
Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the benchmark PSG and HSAT monitors.
For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software

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: Frederik Massie, 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)

August 15, 2018

Primary Completion (Anticipated)

September 15, 2019

Study Completion (Anticipated)

September 15, 2019

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

August 15, 2018

First Posted (Actual)

August 17, 2018

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17/034-11/06/2018

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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