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Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C

Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01738022
Enrollment
0
Registered
2012-11-30
Start date
2012-12-08
Completion date
2017-02-07
Last updated
2019-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Keywords

Sleep apnea, Pathophysiology

Brief summary

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.

Detailed description

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.

Interventions

OTHERAdministration of gas mixtures

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in peak inspiratory flow10 - 15 secondsObserved peak inspiratory flow while breathing different gas mixtures will be compared to model predicted flows. Subjects will breathe different gas mixtures for 2 consecutive breaths only. Therefore the time frame is equal to one breath before gas mixture administration and two breaths after (usually 10-15 seconds).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026