Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test

E

Ectosense

Status

Unknown

Conditions

Sleep Apnea

Treatments

Device: NightOwl HSAT

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03635918
17/034-11/06/2018

Details and patient eligibility

About

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

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

indication for a sleep study

Exclusion criteria

Mentally disabled people

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

500 participants in 1 patient group

NightOwl HSAT
Other group
Description:
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.
Treatment:
Device: NightOwl HSAT

Trial contacts and locations

1

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Central trial contact

Frederik Massie, ir.

Data sourced from clinicaltrials.gov

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