Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03635918

Enrollment

500

Registered

2018-08-17

Start date

2018-08-15

Completion date

2019-09-15

Last updated

2018-08-17

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

Conditions

Sleep Apnea

Brief summary

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

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 benchmark HSAT 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

Design outcomes

Primary

Measure	Time frame	Description
Apnea-Hypopnea Index (AHI)	For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software	Comparison of the AHI derived from the NightOwl HSAT to that of the benchmark PSG and HSAT monitors.

Secondary

Measure	Time frame	Description
Sleep-wake discrimination	For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software	Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the benchmark PSG and HSAT monitors.

Countries

Belgium

Contacts

Primary ContactFrederik Massie, ir.

frederik.massie@ectosense.com474942710

Outcome results

None listed

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