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

Fisher & Paykel Healthcare

Status: Terminated

Conditions: Chronic Obstructive Pulmonary Disease; Neuromuscular Disease; Obstructive Sleep Apnea; Obesity Hypoventilation Syndrome

Treatments: Device: Simplus/Eson

Study type: Interventional

Funder types: Industry

Identifiers

NCT02726048

CIA178

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Full face/Nasal masks

Experimental group

Description:

Simplus/Eson

Treatment:

Device: Simplus/Eson