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Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea

NCT02297789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2015-07-24

No results posted yet for this study

Summary

Currently Fisher \& Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear.

The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.

Conditions

Interventions

DEVICE

Investigative Full Face Mask with Headgear

Sponsors & Collaborators

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Principal Investigators

  • Bhavi Ogra, BSc · Fisher & Paykel Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT02297789 on ClinicalTrials.gov