Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-12-31

Brief Summary

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The purpose of the study is to evaluate if using the Acclimate feature at the beginning of Positive Airway Pressure (PAP) therapy results in patients using their PAP therapy at least as long as they would standard therapy. Additionally, the Acclimate feature will be evaluated with regard to patient comfort, ease of acceptance of PAP therapy, leak events, and respiratory events.

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Detailed Description

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Acclimate has been designed as a comfort feature for patients starting PAP therapy. The feature allows acclimatization to the targeted positive airway pressure setting. Using the Acclimate feature, the pressure increases incrementally over a period of time. The feature can be only be used for a set period of time, afterwards which the device initiates the therapeutic session at the prescribed pressure.

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

SINGLE

Participants

Study Groups

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Fixed Mode + Acclimate

S9 Elite flow generator with Acclimate feature activated.

Group Type EXPERIMENTAL

S9 Elite with Acclimate

Intervention Type DEVICE

S9 Elite Flow Generator with Acclimate feature activated

Fixed Mode only

S9 Elite Flow Generator with Fixed Mode only

Group Type ACTIVE_COMPARATOR

S9 Elite

Intervention Type DEVICE

S9 Elite Flow Generator

Interventions

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S9 Elite with Acclimate

S9 Elite Flow Generator with Acclimate feature activated

Intervention Type DEVICE

S9 Elite

S9 Elite Flow Generator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects ≥18 years of age.
* Recent diagnosis of moderate to severe OSA where fixed PAP is clinically indicated.
* Naïve to PAP therapy.

Exclusion Criteria

* Patients requiring supplemental oxygen.
* Patients with a history of pneumothorax, pneumomediastinum, cavities or cysts in the lung.
* Previous surgery to the brain, middle or inner ear, pituitary gland or sinuses.
* Middle ear infection or perforated ear drum.
* Ongoing sinus infection/sinusitis.
* Clinically significant epistaxis.
* Predominant central sleep apneas in the subject's PSG.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No