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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Sleep Disordered Breathing
• Intervention / Treatment: Device: Alternative sizing model based trial mask; Device: Prototype Full Face Mask

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
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 2013
    • Fisher & Paykel Healthcare
  • Wellington, New Zealand, 6035
    • Bowen Hospital
  • Hawkes Bay
    • Hastings, Hawkes Bay, New Zealand, 1420
      • Hastings Memorial Hospital
  • Waikato
    • Hamilton, Waikato, New Zealand, 3204
      • Waikato Hospital (Waikato DHB)

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seal Comfort	Obtained from subjective questionnaire	Up to 3 weeks in-home
Subjective Seal Leak	Obtained from subjective questionnaire	Up to 3 weeks in-home
Objective Seal Leak	Measured by device data	Up to 3 weeks in-home

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective correct mask selection	Measured by device leak data	Up to 3 weeks in-home
Subjective correct mask selection	Measured by subjective questionnaire	Up to 3 weeks in-home

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 11, 2017
• Primary Completion (ACTUAL): November 3, 2017
• Study Completion (ACTUAL): December 20, 2017

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: July 29, 2016
• First Posted (ESTIMATE): August 1, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

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-194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot investigation from which data will be used to inform product development on future projects and investigations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No