Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study C

NCT01738022 | Withdrawn

• 2 other identifiers: 2012P000957C1R01HL102321-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea

Keywords

Sleep apnea; Pathophysiology

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Gas mixture administration

EXPERIMENTAL

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

Interventions

Administration of gas mixtures OTHER

Also known as: Heliox, Sulfur-hexafluoride, Neon

Gas mixture administration

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal subjects or patients with OSA

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

heliox; Sulfur Hexafluoride; Neon

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Gases; Sulfur Compounds; Noble Gases; Elements

Study Officials

• David A Wellman, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 14, 2012
• First Posted: November 30, 2012
• Study Start: December 8, 2012
• Primary Completion: February 7, 2017
• Study Completion: February 7, 2017
• Last Updated: July 11, 2019

Record last verified: 2019-07

Locations

US (1)