NCT03385187

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 29, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 28, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

December 20, 2017

Last Update Submit

March 19, 2019

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Sleep-wake discrimination

    At time of the diagnostic night

Study Arms (1)

NightOwl HSAT

OTHER

Patient undergoes a NightOwl sleep apnea test whilst simultaneously undergoing a sleep study with a Type I sleep monitor (Lab-PSG) and optionally a Type IV sleep monitor.

Device: NightOwl HSAT

Interventions

NightOwl HSATDEVICE

Patient wears the NightOwl sensor device

NightOwl HSAT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for a sleep study

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Duarte Mendes de Almeida, Ir.

    Ectosense NV

    STUDY DIRECTOR

Central Study Contacts

Duarte Mendes de Almeida, Ir.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2017

First Posted

December 28, 2017

Study Start

June 29, 2017

Primary Completion

September 15, 2019

Study Completion

December 15, 2019

Last Updated

March 21, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)