Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-08

Study Completion Date

2017-02-07

Brief Summary

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In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Models to study mechanisms of airway collapse have been proposed. However, these models have not been tested in the human upper airway. Gas density and viscosity are different gas properties that influence upper airway collapse and are variables of different models. In this study, subjects will breathe gas mixtures of different densities and viscosities for brief periods of time in order to test those models.

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Detailed Description

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Models to study mechanisms of airway collapse have been proposed. However, these models have not been tested in the human upper airway. Gas density and viscosity are different gas properties that influence upper airway collapse and are variables of different models.

In this study, subjects will breathe gas mixtures of different densities (helium and sulfur-hexafluoride) or viscosity (neon) for brief periods of time during flow-limited breaths. Flow limitation will be induced by sustained reductions of continuous positive airway pressure (CPAP). The investigators will test some models of upper airway collapse by observing if flow while breathing different gas mixtures scales according to the differences in density and viscosity.

Conditions

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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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Gas mixture administration

Subjects will breathe different gas mixtures with different densities and viscosity for brief periods in order to promote changes in peak inspiratory flow

Group Type EXPERIMENTAL

Administration of gas mixtures

Intervention Type OTHER

Interventions

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Administration of gas mixtures

Intervention Type OTHER

Other Intervention Names

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Heliox Sulfur-hexafluoride Neon

Eligibility Criteria

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Inclusion Criteria

* Normal subjects or patients with OSA

Exclusion Criteria

* Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
* Any medication known to influence breathing, sleep/arousal or muscle physiology
* Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
* Claustrophobia
* Inability to sleep supine
* Allergy to lidocaine or oxymetazoline hydrochloride
* For women: Pregnancy

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes