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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02938208
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sleep Disordered Breathing Obstructive Sleep Apnea Device: Jupiter Full Face Mask Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Investigation to Test a Prototype Full-face Mask in the Home Setting
Actual Study Start Date : November 3, 2016
Actual Primary Completion Date : November 21, 2016
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Objective mask leak data measurement (System Leak) [ Time Frame: Up to 21 ± 6 days in-home ]
    Obtained from participant's CPAP device, measured in L/min

  2. Subjective Measurement of leak assessed using a Subjective Questionnaire [ Time Frame: Up to 21 ± 6 days in-home ]
    Subjective Questionnaire

  3. Comfort assessed using a Subjective Questionnaire [ Time Frame: Up to 21 ± 6 days in-home ]
    Subjective Questionnaire

  4. Stability assessed using a Subjective Questionnaire [ Time Frame: Up to 21 ± 6 days in-home ]
    Subjective Questionnaire

  5. Draft assessed using a Subjective Questionnaire [ Time Frame: Up to 21 ± 6 days in-home ]
    Subjective Questionnaire

  6. Noise assessed using a Subjective Questionnaire [ Time Frame: Up to 21 ± 6 days in-home ]
    Subjective Questionnaire


Secondary Outcome Measures :
  1. Preference of Mask assessed using a Subjective Questionnaire [ Time Frame: Up to 21 ± 6 days in-home ]
    Subjective Questionnaire

  2. Usability via mask unboxing/fitting exercise with a subjective questionnaire [ Time Frame: Up to 21 ± 6 days in-home ]
    Usability activity during visit 2 with subjective questionnaire after activity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938208


Locations
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New Zealand
Fisher & Paykel Healthcare
Auckland, New Zealand, 2013
Wellsleep: Bowen Hospital
Wellington, New Zealand, 6035
Sponsors and Collaborators
Fisher and Paykel Healthcare
Investigators
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Principal Investigator: Kayan Gonda, BSc Sponsor Employee

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Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT02938208     History of Changes
Other Study ID Numbers: CIA-198
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases