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

NCT02726048 — Not applicable, Terminated, 4 participants, Fisher and Paykel Healthcare

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Registry	NCT02726048
Status	Terminated - Fisher \& Paykel Healthcare placed an administrative hold on the Simplus and Eson Non-Invasive Ventilation Evaluation study being conducted at Charite, Berlin
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	4 (Actual)
Sponsor	Fisher and Paykel Healthcare (Industry)
Conditions	Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Neuromuscular Disease
Interventions	Simplus/Eson (Device)
Dates	start 2016-04-01, primary completion 2017-07-01, completion 2017-07-01, first posted 2016-04-01, last updated 2018-08-02
Locations	1 site in Germany

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Full face/Nasal masks	Experimental	Device: Simplus/Eson	Simplus/Eson

Simplus/Eson (Device): Released product Simplus and Eson masks

+Outcome measures

Primary outcomes

Objective Leak data [2 weeks]: Obtained from the participant's device

Secondary outcomes

Subjective measurement of Leak [2 weeks]: Questionnaire
Subjective measurement of Comfort [2 weeks]: Questionnaire
Subjective measurement of Ease of Use [2 weeks]: Questionnaire

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Charité - Universitätsmedizin Berlin	Berlin	Germany

+Investigators

Ingo Fietze, Professor, Principal investigator, Charite University, Berlin, Germany