Actively Recruiting
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
Led by University of South Florida · Updated on 2025-01-24
52
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects 18 to 65 years old
- At least one year history of perennial allergic or non-allergic rhinitis
- On maximum recommended doses of nasal glucocorticosteroids for at least one month
- Mild obstructive sleep apnea with apnea hypopnea index (AHI) between 5 and 15 and minimum oxygen saturation (SpO2) of 88
- Moderate to severe nasal congestion with average Nasal Congestion Visual Analog Scale (VAS) scores greater than 3
- Average Congestion Quantifier 7 (CQ7) score of 7 based on weekly symptoms
- Willingness to participate and provide informed consent
You will not qualify if you...
- Allergy or hypersensitivity to oxymetazoline or fluticasone propionate
- Receiving allergen immunotherapy but not on stable maintenance for at least 30 days before the study
- Enrollment within eight weeks before, during, or six weeks after seasonal exacerbations of allergic rhinitis
- Pregnancy or lactation
- Nasal diseases affecting drug delivery such as sinusitis, nasal polyps, or major nasal structural problems
- Respiratory infections or antibiotic use within 14 days
- Asthma or COPD requiring roflumilast or high doses of inhaled medications
- Use of systemic glucocorticosteroids within one month before or during the study
- Uncontrolled cardiovascular diseases including hypertension, arrhythmias, or heart failure
- Insulin-dependent diabetes mellitus or diabetic retinopathy
- Severe oxygen desaturation during sleep (SpO2 below 88% for over 5 minutes)
- Hypertension requiring more than two medications except hydrochlorothiazide
- History of drug or alcohol abuse in past 5 years or current substance abuse
- Inability to comply with study procedures or communicate with investigators
- History of benign prostate hypertrophy needing treatment
- Psychiatric problems impairing study participation
- Planned hospitalization during study
- Physical infirmity, disability, or location preventing regular visits
- Obstructive sleep apnea requiring CPAP therapy
- Central sleep apnea or moderate to severe OSA with severe oxygen desaturation
- Recent use of excluded medications within specified timeframes before study start
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Usf Asthma Allergy and Immunology Cru
Tampa, Florida, United States, 33613
Actively Recruiting
Research Team
C
Catherine R Smith
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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