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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03385187
• Other study ID #: 17/034U
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2017
• Est. completion date: December 15, 2019

Study information

• Verified date: March 2019
• Source: Ectosense NV
• Contact: Duarte Mendes de Almeida, Ir.
• Phone: +32 468 17 27 89
• Email: d.mdealmeida[@]ectosense.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 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

• Known allergy to Plexiglas (PMMA) or other acrylates

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

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 Type I and Type IV sleep monitors	At the time of the diagnostic night
Secondary	Sleep-wake discrimination	Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors	At time of the diagnostic night