NCT03635918

Brief Summary

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

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
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2018

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

First Submitted

Initial submission to the registry

August 14, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

August 14, 2018

Last Update Submit

August 15, 2018

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 benchmark PSG and HSAT monitors.

    For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software

Secondary Outcomes (1)

  • 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

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 benchmark HSAT 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

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

  • Frederik Massie, ir.

    Ectosense NV

    STUDY DIRECTOR

Central Study Contacts

Frederik Massie, ir.

CONTACT

474942710frederik.massie@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

August 14, 2018

First Posted

August 17, 2018

Study Start

August 15, 2018

Primary Completion

September 15, 2019

Study Completion

September 15, 2019

Last Updated

August 17, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)