Chronic Obstructive Pulmonary Disease, Neuromuscular Disease, Obesity Hypoventilation Syndrome, Obstructive Sleep Apnea
Conditions
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.
Interventions
DEVICESimplus/Eson
Released product Simplus and Eson masks
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Leak data | 2 weeks | Obtained from the participant's device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective measurement of Leak | 2 weeks | Questionnaire |
| Subjective measurement of Comfort | 2 weeks | Questionnaire |
| Subjective measurement of Ease of Use | 2 weeks | Questionnaire |
Countries
Germany
Outcome results
None listed