The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)

NCT ID: NCT02894242

Last Updated: 2017-04-04

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-03-31

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 minimum of 20 OSA participants who currently use a nasal pillows mask will be recruited for the trial. Participant will be on the trial for three weeks - first week will be a collection of Positive Airway Pressure (PAP) baseline data on the participant's usual mask. The participant will then use the trial mask in-home for 2 weeks. There is also an option of a two month extension if the participant wish to continue on the trial mask.

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 Deimos Nasal Pillows Mask

Participants to use nasal pillows mask in-home for 2 weeks.

Group Type EXPERIMENTAL

F&P Deimos Nasal Pillows Mask

Intervention Type DEVICE

Investigative Nasal Pillows Mask to be used for OSA therapy

Interventions

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F&P Deimos Nasal Pillows Mask

Investigative Nasal Pillows Mask to be used for OSA therapy

Intervention Type DEVICE

Other Intervention Names

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Deimos Mask

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 pillows 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, Bsc PgDip

Role: PRINCIPAL_INVESTIGATOR

Sponsor Employee

Locations

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Fisher and Paykel Healthcare

Auckland, , New Zealand

Site Status

Hawkes Bay Fallen Soldiers' Memorial Hospital

Hastings, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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CIA-197

Identifier Type: -

Identifier Source: org_study_id

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