Pilairo Lab Market Research

NCT ID: NCT01824979

Last Updated: 2018-03-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-05-31

Brief Summary

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The purpose of the study is to observe the Pilairo mask in a lab setting.

Detailed Description

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The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other commercially available masks for continuous positive airwary pressure (CPAP) therapy.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pilairo mask

Pilairo nasal pillows mask during CPAP titration

Group Type EXPERIMENTAL

CPAP mask ( Pilairo)

Intervention Type DEVICE

Other CPAP mask

Other CPAP mask during CPAP titration

Group Type ACTIVE_COMPARATOR

Other CPAP mask

Intervention Type PROCEDURE

Interventions

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CPAP mask ( Pilairo)

Intervention Type DEVICE

Other CPAP mask

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Apnea Hypopnea Indea \>15 from diagnostic study
* Minimum 18 years of age

Exclusion Criteria

* Inability ot give informed consent
* History of intolerance to CPAP
* Anatomical or physiological conditions making CPAP therapy inappropriate
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

Locations

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Peninsula Sleep Center Inc

Burlingame, California, United States

Site Status

Countries

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United States

Other Identifiers

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CIA76

Identifier Type: -

Identifier Source: org_study_id

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