NCT02630121

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

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.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 of upper airway resistance. 2. The Congestion Quantifier 7 (CQ7) questionnaire will be used to assess for an improvement in nasal congestion based on symptoms from the prior week. 3. The Nasal Congestion Visual Analog Scale (VAS) will be used to identify the changes in the severity of nasal congestion on a day to day basis. 4. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) will be used to assess the impact of perennial rhinitis and nasal congestion on activities of daily living.

Conditions

• Sleep Apnea
• Chronic Nasal Congestion

Interventions

Type	Name	Description
DRUG	Oxymetazoline Hydrochloride	Proportion of the subjects with 50% reduction in AHI.
DRUG	Placebo	Proportion of the subjects with 50% reduction in AHI.

Timeline

• Start date: 2023-04-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2015-12-15
• Last updated: 2025-01-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study