Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test

Last updated: August 15, 2018
Sponsor: Ectosense NV
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Apnea Syndromes

Sleep Disorders

Treatment

N/A

Clinical Study ID

NCT03635918
17/034-11/06/2018
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • indication for a sleep study

Exclusion

Exclusion Criteria:

  • Mentally disabled people

Study Design

Total Participants: 500
Study Start date:
August 15, 2018
Estimated Completion Date:
September 15, 2019

Study 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.

Connect with a study center

  • Ziekenhuis Oost-Limburg

    Genk, Limburg 3600
    Belgium

    Active - Recruiting

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