Clincosm LogoSign in Get a demo

Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01738022
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
0
Enrollment
1
Location
1
Arm
50
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Administration of gas mixtures
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C
Actual Study Start Date :
Dec 8, 2012
Actual Primary Completion Date :
Feb 7, 2017
Actual Study Completion Date :
Feb 7, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Other: Administration of gas mixtures
Other Names:
  • Heliox
  • Sulfur-hexafluoride
  • Neon

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Difference in peak inspiratory flow [10 - 15 seconds]

      Observed 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Brigham and Women's Hospital
    • National Heart, Lung, and Blood Institute (NHLBI)

    Investigators

    • Principal Investigator: David A Wellman, MD, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Andrew Wellman, Principal Investigator, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT01738022
    Other Study ID Numbers:
    • 2012P000957C
    • 1R01HL102321-01A1
    First Posted:
    Nov 30, 2012
    Last Update Posted:
    Jul 11, 2019
    Last Verified:
    Jul 1, 2019
    Keywords provided by David Andrew Wellman, Principal Investigator, Brigham and Women's Hospital
    Sleep apnea
    Pathophysiology
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea Syndromes

    Study Results

    No Results Posted as of Jul 11, 2019