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

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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

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)

4 participants in 1 patient group

Full face/Nasal masks
Experimental group
Description:
Simplus/Eson
Treatment:
Device: Simplus/Eson

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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