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

Fisher and Paykel Healthcare4 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity Hypoventilation Syndrome Obstructive Sleep Apnea Chronic Obstructive Pulmonary Disease Neuromuscular Disease

Interventions

Simplus/EsonDEVICE

Released product Simplus and Eson masks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Charité - Universitätsmedizin Berlin

Berlin, Germany

Outcomes

Primary Outcomes

Objective Leak data

Obtained from the participant's device

Time frame: 2 weeks

Secondary Outcomes

Subjective measurement of Leak

Questionnaire

Time frame: 2 weeks

Subjective measurement of Comfort

Questionnaire

Time frame: 2 weeks

Subjective measurement of Ease of Use

Questionnaire

Time frame: 2 weeks

Data from ClinicalTrials.gov

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