DREAM: Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea Manifestations?
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Does Inhaled Fluticasone REsult in Obstructive Sleep Apnea? DREAM-A Pilot Study|
- The primary outcome measure for this study is critical closing pressure (Pcrit) change from baseline with 16-week of high dose inhaled FP treatment. [ Time Frame: End of study 3/2011 ] [ Designated as safety issue: No ]UAW collapsibility, as measured by critical closing pressure (Pcrit), defined as the maximum nasal pressure at which the UAW occludes.
- Severity of obstructive SDB, sleep quality and quality of life related to sleep apnea assessed on validated questionnaires (SA-SDQ, ESS, PSQI, and SAQLI [ Time Frame: End of study 3/2011 ] [ Designated as safety issue: No ]Secondary goals include evaluating effects of this medication on severity of obstructive SDB (validated SA-SDQ)
- Tongue strength and fatigability (assessed using the Iowa Oral Performance Instrument [ Time Frame: End of study 03/2011 ] [ Designated as safety issue: No ]The Iowa Oral Performance Instrument (IOPI) will be used. This instrument has a standard-sized air-filled polymer balloon, called tongue sensor or bulb, which can be inserted between the tongue blade and the roof of the mouth.
|Study Start Date:||March 2009|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Drug: fluticasone propionate
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01184118
|United States, Wisconsin|
|Univeristy of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Mihaela Teodorescu, MD||University of Wisconsin, Madison|