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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

NCT02851628 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-04-18

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Principal Investigators

  • Kayan Gonda, BSc · Sponsor Employee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-11
Primary Completion
2017-11-03
Completion
2017-12-20

Countries

  • New Zealand

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02851628 on ClinicalTrials.gov