Obstructive Sleep Apnea Clinical Trial
Official title:
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea
| Verified date | January 2018 |
| Source | Fisher and Paykel Healthcare |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | June 5, 2017 |
| Est. primary completion date | June 5, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Adult (18+ years of age) - Able to give consent - Apnea hypopnea Index (AHI)= 5 on diagnostic night - Prescribed PAP for OSA - Existing nasal mask user Exclusion Criteria: - Inability to give consent - Patients who are in a coma or a decreased level of consciousness - Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure) - Commercial drivers who are investigated by New Zealand Transport Agency - Current diagnosis of carbon dioxide (CO2) retention - Pregnant or may think they are pregnant |
| Country | Name | City | State |
|---|---|---|---|
| New Zealand | Fisher and Paykel Healthcare | Auckland |
| Lead Sponsor | Collaborator |
|---|---|
| Fisher and Paykel Healthcare |
New Zealand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Ease of use | Subjective questionnaire | 1 night | |
| Primary | Acceptability | Subjective questionnaire | 1 night | |
| Secondary | Objective leak data | Data obtained from participant's device - Objective | 1 night |
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