Investigative Headgear With CPAP Mask

NCT ID: NCT02323035

Last Updated: 2019-04-18

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

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-11-30

Brief Summary

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This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.

Detailed Description

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Up to 300 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level PAP for the treatment of their OSA. These include current CPAP mask users.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Headgear

Investigative Headgear with CPAP Mask.

Group Type EXPERIMENTAL

Headgear

Intervention Type DEVICE

Investigative Headgear with CPAP Mask.

Interventions

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Headgear

Investigative Headgear with CPAP Mask.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* AHI≥5 from the diagnostic night
* ≥18 years of age
* Prescribed CPAP or Bilevel therapy for OSA
* Existing CPAP mask users

Exclusion Criteria

* Inability to give informed consent
* Patient intolerant to PAP
* Anatomical or physiological conditions making PAP therapy inappropriate
* History of respiratory disease or CO2 retention.
* Pregnant or think they may be pregnant
* Investigated by Land Transport Safety Authority
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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Bhavi Ogra, BSc

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Scientist

Locations

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Fisher & Paykel Healthcare

Auckland, , New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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CIA150

Identifier Type: -

Identifier Source: org_study_id

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