The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea

NCT ID: NCT03156413

Last Updated: 2018-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-29

Study Completion Date

2017-06-05

Brief Summary

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This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.

Detailed Description

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A maximum of 12 OSA participants who currently use a nasal mask will be recruited for the trial. Participant will be on the trial for 1 night (in-lab)

Conditions

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Sleep Disordered Breathing Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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F&P Nasal Mask

Trial nasal pillows CPAP mask

Group Type EXPERIMENTAL

F&P nasal mask

Intervention Type DEVICE

Investigative Nasal Mask to be used for OSA therapy

Interventions

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F&P nasal mask

Investigative Nasal Mask to be used for OSA therapy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult (18+ years of age)
* Able to give consent
* Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
* Prescribed PAP for OSA
* Existing nasal 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 automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
* Commercial drivers who are investigated by New Zealand Transport Agency
* Current diagnosis of carbon dioxide (CO2) retention
* Pregnant or may think they are pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Gunson

Role: PRINCIPAL_INVESTIGATOR

Sponsor Employee

Locations

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Fisher and Paykel Healthcare

Auckland, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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CIA-206

Identifier Type: -

Identifier Source: org_study_id

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