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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03385187

Enrollment

450

Registered

2017-12-28

Start date

2017-06-29

Completion date

2019-12-15

Last updated

2019-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

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.

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.

Interventions

DEVICENightOwl HSAT

Patient wears the NightOwl sensor device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Indication for a sleep study

Exclusion criteria

* Mentally disabled people * Known allergy to Plexiglas (PMMA) or other acrylates

Design outcomes

Primary

Measure	Time frame	Description
Apnea-Hypopnea Index (AHI)	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

Measure	Time frame	Description
Sleep-wake discrimination	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

Countries

Belgium

Contacts

Primary ContactDuarte Mendes de Almeida, Ir.

d.mdealmeida@ectosense.com+32 468 17 27 89

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026