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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Sleep Disordered Breathing
• Intervention / Treatment: Device: Jupiter Full Face Mask

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 2013
    • Fisher & Paykel Healthcare
  • Wellington, New Zealand, 6035
    • Wellsleep: Bowen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jupiter Full Face Mask; Participants to use full face mask in-home for a 14 ± 3 days in-home.	Device: Jupiter Full Face Mask; Full Face Mask for the treatment of obstructive sleep apnea (OSA) using CPAP therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective mask leak data measurement (System Leak)	Obtained from participant's CPAP device, measured in L/min	Up to 21 ± 6 days in-home
Subjective Measurement of leak assessed using a Subjective Questionnaire	Subjective Questionnaire	Up to 21 ± 6 days in-home
Comfort assessed using a Subjective Questionnaire	Subjective Questionnaire	Up to 21 ± 6 days in-home
Stability assessed using a Subjective Questionnaire	Subjective Questionnaire	Up to 21 ± 6 days in-home
Draft assessed using a Subjective Questionnaire	Subjective Questionnaire	Up to 21 ± 6 days in-home
Noise assessed using a Subjective Questionnaire	Subjective Questionnaire	Up to 21 ± 6 days in-home

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preference of Mask assessed using a Subjective Questionnaire	Subjective Questionnaire	Up to 21 ± 6 days in-home
Usability via mask unboxing/fitting exercise with a subjective questionnaire	Usability activity during visit 2 with subjective questionnaire after activity	Up to 21 ± 6 days in-home

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2016
• Primary Completion (Actual): November 21, 2016
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: October 16, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: CIA-198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This is an investigation for a prototype full face mask. The results from this trial will feedback into product development on further improving the full face mask for future trials and impending release of the product.