Back to resultsSimplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany
Primary Purpose
Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Simplus/Eson
Sponsored by
About this trial
This is an interventional treatment trial for Obesity Hypoventilation Syndrome
Eligibility Criteria
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
Sites / Locations
- Charité - Universitätsmedizin Berlin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Full face/Nasal masks
Arm Description
Simplus/Eson
Outcomes
Primary Outcome Measures
Objective Leak data
Obtained from the participant's device
Secondary Outcome Measures
Subjective measurement of Leak
Questionnaire
Subjective measurement of Comfort
Questionnaire
Subjective measurement of Ease of Use
Questionnaire
Full Information
NCT ID
NCT02726048
First Posted
March 29, 2016
Last Updated
July 31, 2018
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02726048
Brief Title
Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany
Official Title
Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Fisher & Paykel Healthcare placed an administrative hold on the Simplus and Eson Non-Invasive Ventilation Evaluation study being conducted at Charite, Berlin
Study Start Date
April 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Neuromuscular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full face/Nasal masks
Arm Type
Experimental
Arm Description
Simplus/Eson
Intervention Type
Device
Intervention Name(s)
Simplus/Eson
Intervention Description
Released product Simplus and Eson masks
Primary Outcome Measure Information:
Title
Objective Leak data
Description
Obtained from the participant's device
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Subjective measurement of Leak
Description
Questionnaire
Time Frame
2 weeks
Title
Subjective measurement of Comfort
Description
Questionnaire
Time Frame
2 weeks
Title
Subjective measurement of Ease of Use
Description
Questionnaire
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingo Fietze, Professor
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany
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