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DREAM: Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea Manifestations? — DREAM  

Lung Disease Clinical Trial

Official title:
Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea? DREAM-A Pilot Study

Clinical Trial Summary

This study is being conducted to find out if the use of inhaled corticosteroids has an affect on upper airway collapsibility and sleep apnea risk. An inhaled corticosteroid is a common asthma controller medication like Flovent. Sleep apnea is w hen someone stops breathing for a short period of time during sleep. For some reason, people with asthma have more sleep apnea and upper airway collapsibility (weakness) than the general population. There are many possible reasons for this and one might be related to the use of inhaled corticosteroids.

The overall hypothesis of this study is to determine whether inhaled fluticasone propionate (FP) increases UAW collapsibility and to assess tongue (genioglossus muscle) dysfunction as a potential underlying mechanism.

Clinical Trial Description

To address this hypothesis, we specifically aim is to determine the effects of 16 weeks of treatment with inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 880 mcg twice daily, on:

Specific Aim 1: UAW collapsibility, as measured by Pcrit during NREM sleep; Specific Aim 2: Severity of obstructive SDB and sleep quality, and quality of life related to sleep apnea assessed on validated questionnaires (Sleep Apnea scale of the Sleep Disorders Questionnaire [SA-SDQ], Epworth Sleepiness Scale [ESS]) and Pittsburgh Sleep Quality Index [PSQI], and Sleep Apnea Quality of Life Index [SAQLI]); Specific Aim 3: Tongue strength and fatigability (assessed using the Iowa Oral Performance Instrument) ;

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01184118
Study type Interventional
Source University of Wisconsin, Madison
Contact
Status Completed
Phase N/A
Start date March 2009
Completion date February 2011
View Details
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