The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)

The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)

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 interface.

Detailed Description

A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.

Overall Status Completed
Start Date November 5, 2018
Completion Date November 30, 2019
Primary Completion Date November 30, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Trial Mask usability 14 ± 4 days in home
Trial mask Performance 14 ± 4 days in home
Secondary Outcome
Measure Time Frame
Trial mask Reliability 5 months and 2 weeks in home
Trial mask performance measured in L/min 14 ± 4 days in home
Enrollment 33
Condition
Intervention

Intervention type: Device

Intervention name: F&P Interface

Description: F&P Interface to be used for OSA therapy

Arm group label: Arm

Eligibility

Criteria:

Inclusion Criteria:

- Adult (18+ years of age)

- Able to give written consent

- AHI ≥ 5 on diagnostic night

- Either prescribed APAP, CPAP or Bi-level PAP for OSA

Exclusion Criteria:

- Inability to give written consent

- Anatomical or physiological conditions making PAP therapy inappropriate

- Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)

- Current diagnosis of respiratory disease or 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
Bhavi Ogra Principal Investigator Clinical Manager
Location
facility
Hawkes Bay Fallen Soldiers' Memorial Hospital | Hastings, Hawkes Bay, 4120, New Zealand
Fisher & Paykel Healthcare | Auckland, 2013, New Zealand
Well Sleep | Wellington, 6035, New Zealand
Location Countries

New Zealand

Verification Date

February 2020

Responsible Party

Responsible party type: Sponsor

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

Arm group label: Arm

Arm group type: Experimental

Description: F&P Interface will be used by OSA participants in-home for 2 weeks.

Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov