Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany

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

Study Overview

• Status: Terminated
• Conditions: Chronic Obstructive Pulmonary Disease; Obstructive Sleep Apnea; Obesity Hypoventilation Syndrome; Neuromuscular Disease
• Intervention / Treatment: Device: Simplus/Eson

Detailed Description

Up to 40 NIV patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a Simplus (if they are existing full face users) or Eson (if they are existing nasal users) to use in-home for 2 weeks. This will consists of male and female participants who have been prescribed with NIV therapy for at least 3 months.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full face/Nasal masks; Simplus/Eson	Device: Simplus/Eson; Released product Simplus and Eson masks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Leak data	Obtained from the participant's device	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective measurement of Leak	Questionnaire	2 weeks
Subjective measurement of Comfort	Questionnaire	2 weeks
Subjective measurement of Ease of Use	Questionnaire	2 weeks

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Ingo Fietze, Professor, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Overnutrition; Nutrition Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Insufficiency; Obesity; Sleep Apnea, Obstructive; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypoventilation; Obesity Hypoventilation Syndrome; Neuromuscular Diseases
• Other Study ID Numbers: CIA178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO