The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea

The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea

Sponsors

Lead sponsor: Fisher and Paykel Healthcare

Source Fisher and Paykel Healthcare
Brief Summary

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.

Detailed Description

A maximum of 12 OSA participants who currently use a nasal mask will be recruited for the trial. Participant will be on the trial for 1 night (in-lab)

Overall Status Completed
Start Date May 29, 2017
Completion Date June 5, 2017
Primary Completion Date June 5, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Ease of use 1 night
Acceptability 1 night
Secondary Outcome
Measure Time Frame
Objective leak data 1 night
Enrollment 12
Condition
Intervention

Intervention type: Device

Intervention name: F&P nasal mask

Description: Investigative Nasal Mask to be used for OSA therapy

Arm group label: F&P Nasal Mask

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Sarah Gunson Principal Investigator Sponsor Employee
Location
facility
Fisher and Paykel Healthcare
Location Countries

New Zealand

Verification Date

January 2018

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: F&P Nasal Mask

Arm group type: Experimental

Description: Trial nasal pillows CPAP mask

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov