Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C

Sleep Apnea Clinical Trial

Official title:

Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01738022
• Other study ID #: 2012P000957C
• Secondary ID: 1R01HL102321-01A
• Status: Withdrawn
• Phase: N/A
• Start date: December 8, 2012
• Est. completion date: February 7, 2017

Study information

• Verified date: July 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 7, 2017
• Est. primary completion date: February 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Other:
• Administration of gas mixtures

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in peak inspiratory flow	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).	10 - 15 seconds