Actively Recruiting
Effect of Oxymetazoline Hydrochloride with Fluticasone Propionate on Sleep Apnea and Nasal Congestion A Randomized, Double-Blinded, Placebo-Controlled Crossover Trial for 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
Researchers are evaluating whether adding intranasal oxymetazoline to ongoing optimal doses of intranasal fluticasone propionate can reduce the number of obstructive apneas and hypopneas per hour of sleep in adults with perennial allergic or non-allergic rhinitis and mild obstructive sleep apnea who continue to have nasal congestion despite maximum nasal glucocorticosteroid treatment. This phase 4, double-blinded, placebo-controlled, crossover study focuses on improving breathing during sleep in this specific group. Participants will receive either oxymetazoline hydrochloride or a placebo in addition to their usual fluticasone propionate treatment. The study treatment lasts for two weeks, during which the apnea hypopnea index (AHI) will be monitored to assess changes in breathing disturbances. The design allows comparison of the effects of the active drug versus placebo on reducing breathing pauses during sleep. Throughout the study, participants will use the NOX T3 portable sleep monitor to measure the AHI and upper airway resistance. They will complete questionnaires assessing nasal congestion severity and quality of life related to rhinitis symptoms. Researchers will track nasal congestion symptoms daily and weekly, and measure improvements in nasal airflow and sleep apnea severity. Safety and treatment effects will be monitored closely during the study period, which lasts for at least two weeks of treatment.
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
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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
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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