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NCT03635918 Clinical Trial

Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test

Sleep Apnea Clinical Trial

Official title:
Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03635918
Other study ID # 17/034-11/06/2018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 15, 2018
Est. completion date September 15, 2019

Study information
Verified date August 2018
Source Ectosense NV
Contact Frederik Massie, ir.
Phone 474942710
Email frederik.massie@ectosense.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date September 15, 2019
Est. primary completion date September 15, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- indication for a sleep study

Exclusion Criteria:

- Mentally disabled people

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• NightOwl HSAT
Patient wears the NightOwl sensor device

Locations
Country Name City State
Belgium Ziekenhuis Oost-Limburg Genk Limburg

Sponsors (2)
Lead Sponsor Collaborator
Ectosense NV Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Apnea-Hypopnea Index (AHI) 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 Sleep-wake discrimination 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
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