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

Not Applicable

Terminated

• Conditions: Obesity Hypoventilation Syndrome; Neuromuscular Disease; Obstructive Sleep Apnea; Chronic Obstructive Pulmonary Disease
• Interventions: Device: Simplus/Eson

• Registration Number: NCT02726048
• Lead Sponsor: Fisher and Paykel Healthcare

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.

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-03-29
• Study Start: 2016-04
• Study First Posted: 2016-04-01
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Full face/Nasal masks	Simplus/Eson	Simplus/Eson

Primary Outcome Measures

Name	Time	Method
Objective Leak data	2 weeks	Obtained from the participant's device

Secondary Outcome Measures

Name	Time	Method
Subjective measurement of Ease of Use	2 weeks	Questionnaire
Subjective measurement of Comfort	2 weeks	Questionnaire
Subjective measurement of Leak	2 weeks	Questionnaire

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany