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

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ClinicalTrials.gov Identifier: NCT03385187
Recruitment Status : Unknown
Verified March 2019 by Ectosense NV.
Recruitment status was:  Recruiting
First Posted : December 28, 2017
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
Ziekenhuis Oost-Limburg
Information provided by (Responsible Party):
Ectosense NV

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Device: NightOwl HSAT Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test
Actual Study Start Date : June 29, 2017
Estimated Primary Completion Date : September 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Indication for a sleep study

Exclusion Criteria:

  • Mentally disabled people
  • Known allergy to Plexiglas (PMMA) or other acrylates
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385187


Contacts
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Contact: Duarte Mendes de Almeida, Ir. +32 468 17 27 89 d.mdealmeida@ectosense.com

Locations
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Belgium
Ziekenhuis Oost-Limburg Recruiting
Genk, Limburg, Belgium, 3600
Contact: Inge Thijs, PhD    089 32 15 55 ext +32    Inge.Thijs@zol.be   
Sponsors and Collaborators
Ectosense NV
Ziekenhuis Oost-Limburg
Investigators
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Study Director: Duarte Mendes de Almeida, Ir. Ectosense NV
More Information
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Responsible Party: Ectosense NV
ClinicalTrials.gov Identifier: NCT03385187    
Other Study ID Numbers: 17/034U
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases