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.

NCT02630121 Phase 4 RECRUITING

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.

Details

Lead sponsor	University of South Florida
Phase	Phase 4
Status	RECRUITING
Enrolment	52
Start date	2023-04-01
Completion	2026-04

Conditions

• Sleep Apnea
• Chronic Nasal Congestion

Interventions

• Oxymetazoline Hydrochloride
• Placebo

Primary outcomes

• The proportion of subjects demonstrating a 50% reduction in the apnea hypopnea index after treatment with oxymetazoline hydrochloride and fluticasone propionate for 2 weeks. — 2 weeks
  This study is a double blinded, placebo control, cross over prospective trial. Each subject will complete the two arms in this study. The subject will be randomized to receive either oxymetazoline hydrochloride plus fluticasone propionate initially or placebo plus fluticasone propionate and complete treatment for a total of 2 weeks respectively. At the completion of each arm (prior to visit 3 and visit 5), the apnea hypopnea index will be measured.

Countries

United States