NCT02726048

Brief Summary

This investigation is designed to evaluate the performance, comfort and ease of use of the Simplus and Eson masks amongst NIV patients who are currently on Bi-level therapy

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

March 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 2, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

March 29, 2016

Last Update Submit

July 31, 2018

Conditions

Obesity Hypoventilation SyndromeObstructive Sleep ApneaChronic Obstructive Pulmonary DiseaseNeuromuscular Disease

Outcome Measures

Primary Outcomes (1)

  • Objective Leak data

    Obtained from the participant's device

    2 weeks

Secondary Outcomes (3)

  • Subjective measurement of Leak

    2 weeks

  • Subjective measurement of Comfort

    2 weeks

  • Subjective measurement of Ease of Use

    2 weeks

Study Arms (1)

Full face/Nasal masks

EXPERIMENTAL

Simplus/Eson

Device: Simplus/Eson

Interventions

Simplus/EsonDEVICE

Released product Simplus and Eson masks

Full face/Nasal masks

Eligibility Criteria

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

You may qualify if:

  • Aged 18+
  • Existing full face mask user or a nasal mask user
  • Prescribed NIV therapy for at least 3 months

You may not qualify if:

  • Inability to give informed consent
  • Pregnant or think they may be pregnant
  • Anatomical or physiological conditions making NIVtherapy inappropriate
  • Patients who are in a coma or decreased level of consciousness
  • Existing Simplus and Eson users

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Obesity Hypoventilation SyndromeSleep Apnea, ObstructivePulmonary Disease, Chronic ObstructiveNeuromuscular Diseases

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesHypoventilationRespiratory InsufficiencySleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesLung Diseases, ObstructiveLung DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ingo Fietze, Professor

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 1, 2016

Study Start

April 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 2, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)