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Oxymetazoline + Fluticasone for Obstructive Sleep Apnea
Study Summary
This trial suggests that adding intranasal oxymetazoline to already-prescribed intranasal fluticasone propionate can decrease the number of apneas and hypopneas per hour of sleep in people with mild obstructive sleep apnea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am between 18 and 65 years old.I have had year-round allergies or nasal symptoms for at least a year.I have been on the highest dose of a specific cholesterol medication for at least a month.I've been on allergen immunotherapy but not on a stable dose for 30 days.If you have year-round allergies, you should not participate in this study for eight weeks before, during, or six weeks after a seasonal allergy flare-up.I have not had a respiratory infection in the last 2 weeks.I haven't taken antibiotics for infections in the last 14 days.You have had issues with drugs or alcohol in the past 5 years.You are currently using alcohol, illegal drugs, benzodiazepines, or narcotics excessively.I have been treated for an enlarged prostate.I am scheduled to be hospitalized during the study.I have sleep apnea and use a CPAP machine.I haven't taken any of the specified medications within 7 days before the trial.I am not pregnant or breastfeeding.I haven't taken steroids for a month.I have moderate to severe nasal congestion.I need strong medication for my asthma or COPD.I have heart problems with high blood pressure or irregular heartbeat.I have been on the highest dose of a specific medication for over a month.I have mild sleep apnea with low oxygen levels during sleep.I am between 18 and 65 years old.I can follow the study's procedures and communicate with the research team.Your congestion score is consistently 7 or higher based on your weekly symptoms.I have diabetes that requires insulin and/or I have eye problems due to diabetes.You have had ongoing allergies or runny nose for at least a year, whether it's from allergies or not.I need more than two medications (excluding hydrochlorothiazide) to control my high blood pressure.I have been diagnosed with severe sleep apnea or my oxygen levels drop below 88% for more than 5 minutes while I sleep.I have moderate to severe nasal congestion.You are allergic to oxymetazoline or fluticasone propionate.I have conditions like sinusitis, nasal polyps, or major nasal issues that could affect medication absorption.You have mild obstructive sleep apnea, with an average of 5 to 15 breathing interruptions per hour during sleep and a minimum oxygen level of 88%.Your average congestion score from two visits is 7 based on your weekly symptoms.
- Group 1: Placebo/Fluticasone Propionate
- Group 2: Oxymetazoline Hydrochloride /Fluticasone Propionate
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the overall enrolment size for this research endeavor?
"Affirmative. Clinicaltrials.gov displays that this research program, which was initially displayed on April 1st 2023 is actively searching for participants. A total of 52 patients must be brought in between a single site."
Does this research effort still need participants to join?
"Affirmative. According to data on clinicaltrials.gov, this medical experiment was published on April 1st 2023 and edited as of November 14th 2022 is actively looking for participants. 52 individuals need to be recruited from a single site."
Are there any known side-effects associated with Oxymetazoline Hydrochloride /Fluticasone Propionate usage?
"There is ample evidence to suggest that Oxymetazoline Hydrochloride/Fluticasone Propionate treatment is safe, warranting a score of 3 on the safety scale. This classification also implies that it has been officially approved."
Is it feasible to join this medical experiment?
"This clinical trial seeks to enrol 52 individuals, aged between 18 and 65 years old, suffering from sleep apnea. Notably, the requisite criteria include having an Average Congestion Quantifier 7 score of seven between visits 1 and 2 as determined by weekly symptoms (average of two scores), being male or female between 18-65 years of age, a minimum one year history of perennial allergic/non-allergic rhinitis., usage of recommended doses for Nasal Corticosteroid Sprays over at least a month period (refer to Table I) ,and average Nasal Congestion VAS greater than 3 but less than"
Does the protocol for this trial include participants over 30 years of age?
"This research protocol necessitates that those hoping to join are aged between 18 and 65. There are 52 studies available for under-18s while 247 clinical trials exist for individuals above the age of 65."
For what ailments is the combination of Oxymetazoline Hydrochloride /Fluticasone Propionate typically prescribed?
"Oxymetazoline Hydrochloride /Fluticasone Propionate is a proven remedy for sinusitis, persistent facial erythema, and rhinorrhoea."
What more has been learned from investigations involving Oxymetazoline Hydrochloride /Fluticasone Propionate?
"At present, there are 16 trials exploring the effects of Oxymetazoline Hydrochloride /Fluticasone Propionate with 2 studies in Phase 3. 25 different medical sites across the nation are running these experiments and many are located near Palo Alto, California."
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