Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea. A Double Blinded Placebo Controlled, Crossover Prospective Trial.
University of South Florida
Summary
The addition of intranasal oxymetazoline for two weeks to already instituted optimal doses of intranasal fluticasone propionate will decrease the total number of obstructive apneas and hypopneas per hour of sleep in subjects with perennial allergic or non-allergic rhinitis and mild obstructive sleep apnea who have persistent nasal congestion despite maximum doses of NGCS.
Description
To evaluate the effectiveness of the addition of intranasal oxymetazoline to ongoing optimal doses of intranasal fluticasone propionate on the apnea/hypopnea index (AHI) in subjects with persistent nasal congestion and mild obstructive sleep apnea secondary to perennial allergic or non-allergic rhinitis despite treatment with the recommended doses of NGCS. The NOX T3 portable sleep monitor will be used to measure the AHI. 1. The Flow Sensor, as part of the NOX T3 portable monitor, will be used to assess flow limitation of the upper airway through calculation of the flattening index, a marker…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male and female subjects 18 - 65 years of age. 2. At least a one year history of perennial allergic or non-allergic rhinitis. 3. Subjects must be on the maximum recommended doses of one of the following NGCS for at least one month. (See Table I) 4. AHI per hour of sleep \> 5 and \<15, minimum SpO2 88, indicating mild obstructive sleep apnea). 5. Average Nasal Congestion VAS of \> 3-10 indicating moderate to severe nasal congestion between visits 1 and 2 based on daily symptoms (average of 7 scores). 6. Average Congestion Quantifier 7 score of 7 between visits 1 and 2 ba…
Interventions
- DrugOxymetazoline Hydrochloride
Proportion of the subjects with 50% reduction in AHI.
- DrugPlacebo
Proportion of the subjects with 50% reduction in AHI.
Location
- Usf Asthma Allergy and Immunology CruTampa, Florida