An Investigation to Test a Prototype Full-face Mask in the Home Setting

An Investigation to Test a Prototype Full-face Mask in the Home Setting

Sponsors

Lead sponsor: Fisher and Paykel Healthcare

Source Fisher and Paykel Healthcare
Brief Summary

This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial.

Detailed Description

This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of subjects with OSA (Ethics reference NTY/08/06/064), Auckland District Health Board (ADHB), or WellSleep Centre (Bowen Hospital, Wellington, NZ).

Participants will be on the trial for 21 days ± 6 days, using the prototypes at home for 14 days ± 3 days. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for 7 days ± 3 days prior to mask fitting with the Jupiter trial mask.

Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation. This study will be conducted in accordance with ICH/GCP Guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor (Bhavi Ogra) as soon as possible.

Overall Status Completed
Start Date November 3, 2016
Completion Date May 31, 2017
Primary Completion Date November 21, 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Objective mask leak data measurement (System Leak) Up to 21 ± 6 days in-home
Subjective Measurement of leak assessed using a Subjective Questionnaire Up to 21 ± 6 days in-home
Comfort assessed using a Subjective Questionnaire Up to 21 ± 6 days in-home
Stability assessed using a Subjective Questionnaire Up to 21 ± 6 days in-home
Draft assessed using a Subjective Questionnaire Up to 21 ± 6 days in-home
Noise assessed using a Subjective Questionnaire Up to 21 ± 6 days in-home
Secondary Outcome
Measure Time Frame
Preference of Mask assessed using a Subjective Questionnaire Up to 21 ± 6 days in-home
Usability via mask unboxing/fitting exercise with a subjective questionnaire Up to 21 ± 6 days in-home
Enrollment 14
Condition
Intervention

Intervention type: Device

Intervention name: Jupiter Full Face Mask

Description: Full Face Mask for the treatment of obstructive sleep apnea (OSA) using CPAP therapy.

Arm group label: Jupiter Full Face Mask

Eligibility

Criteria:

Inclusion Criteria

- 18+ years of age

- Diagnosed with OSA by a practicing physician

- Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP)). Patient can be naïve to CPAP therapy or experienced (6 months and more)

- Existing full face mask users

- Patients who are able to put on and remove their current mask without gross difficulty relating to an existing condition (e.g. arthritis of the hands).

Exclusion Criteria

- Inability to give informed consent

- Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture)

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

- Current diagnosis of CO2 retention

- Pregnant or think they may be pregnant

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Kayan Gonda, BSc Principal Investigator Sponsor Employee
Location
facility
Fisher & Paykel Healthcare | Auckland, 2013, New Zealand
Wellsleep: Bowen Hospital | Wellington, 6035, New Zealand
Location Countries

New Zealand

Verification Date

July 2017

Responsible Party

Responsible party type: Sponsor

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

Arm group label: Jupiter Full Face Mask

Arm group type: Experimental

Description: Participants to use full face mask in-home for a 14 ± 3 days in-home.

Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov