Trials / Terminated
TerminatedNCT02726048
Simplus and Eson Non-Invasive Ventilation (NIV) Evaluation - Germany
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Fisher and Paykel Healthcare · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Obesity Hypoventilation Syndrome
- Obstructive Sleep Apnea
- Chronic Obstructive Pulmonary Disease
- Neuromuscular Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Simplus/Eson | Released product Simplus and Eson masks |
Timeline
- Start date
- 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 across 1 country: Germany
Source: ClinicalTrials.gov record NCT02726048. Inclusion in this directory is not an endorsement.