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The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort

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ClinicalTrials.gov Identifier: NCT02851628
Recruitment Status : Completed
First Posted : August 1, 2016
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

Brief Summary:
The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask.

Condition or disease Intervention/treatment Phase
Sleep Disordered Breathing Obstructive Sleep Apnea Device: Alternative sizing model based trial mask Device: Prototype Full Face Mask Not Applicable

Detailed Description:

The investigation is a prospective non-blinded and semi-randomized investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask. A cohort of up to 38 pre-determined current nasal and full face mask users will be recruited by Fisher & Paykel Healthcare in Auckland New Zealand, Waikato DHB in Hamilton New Zealand, Hawkes Bay DHB in Hastings New Zealand and WellSleep Centre in Wellington New Zealand.

The study will involve baseline (visit one) gathering the participants' prescribed PAP therapy pressure and their usual mask (to have up-to-date records). The next visit (visit 2) 7 ± 4 days after visit 1, the participants will be fit the Prototype Full Face Mask (PFFM) mask or the alternative sizing based trial mask. At visit 3, which will be after 7 ± 4 days from visit 2, the participants will be crossed over to the mask. At visit 4, 7 ± 4 days after visit 3, all masks and devices will be collected from the participants.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full-face Masks in the Treatment of OSA in Terms of Performance and Comfort
Actual Study Start Date : September 11, 2017
Actual Primary Completion Date : November 3, 2017
Actual Study Completion Date : December 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alternative sizing model trial mask
In this arm participants who are randomized to the alternative sizing model based mask will be given the alternative sizing model based mask to use in home for the duration of this arm.
Device: Alternative sizing model based trial mask
A trial full face mask to be used for this trial for the treatment of obstructive sleep apnea using CPAP therapy.

Active Comparator: Prototype Full Face Mask (PFFM)
In this arm, participants who are randomized to the PFFM will be given the PFFM to use in-home for the duration of this arm.
Device: Prototype Full Face Mask
A prototype full face mask with previous clinical trial experience used for the treatment of obstructive sleep apnea using CPAP therapy.




Primary Outcome Measures :
  1. Seal Comfort [ Time Frame: Up to 3 weeks in-home ]
    Obtained from subjective questionnaire

  2. Subjective Seal Leak [ Time Frame: Up to 3 weeks in-home ]
    Obtained from subjective questionnaire

  3. Objective Seal Leak [ Time Frame: Up to 3 weeks in-home ]
    Measured by device data


Secondary Outcome Measures :
  1. Objective correct mask selection [ Time Frame: Up to 3 weeks in-home ]
    Measured by device leak data

  2. Subjective correct mask selection [ Time Frame: Up to 3 weeks in-home ]
    Measured by subjective questionnaire



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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:

  • Adult (18+ years of age)
  • Able to give consent
  • Apnea Hypopnea Index (AHI) ≥ 5 on diagnostic night
  • Prescribed a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis
  • Existing nasal or full face 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 APAP therapy inappropriate (e.g. unconsolidated facial structure)
  • Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
  • Current diagnosis of CO2 retention
  • Pregnant or may think they are 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): NCT02851628


Locations
New Zealand
Hastings Memorial Hospital
Hastings, Hawkes Bay, New Zealand, 1420
Waikato Hospital (Waikato DHB)
Hamilton, Waikato, New Zealand, 3204
Fisher & Paykel Healthcare
Auckland, New Zealand, 2013
Bowen Hospital
Wellington, New Zealand, 6035
Sponsors and Collaborators
Fisher and Paykel Healthcare
Investigators
Principal Investigator: Kayan Gonda, BSc Sponsor Employee

Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT02851628     History of Changes
Other Study ID Numbers: CIA-194
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a pilot investigation from which data will be used to inform product development on future projects and investigations.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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