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New treatment option for Sleep Apnea
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
ClinicalTrials.gov ID: NCT02630121
What this study is testing
What is Oxymetazoline Hydrochloride?
Oxymetazoline Hydrochloride is an investigational medicine, given as an once-daily, being studied as a potential treatment for sleep apnea.
Also referred to as Afrin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male and female people 18 - 65 years of age.
- At least a one year history of perennial allergic or non-allergic rhinitis.
- people must be on the maximum recommended doses of one of the following NGCS for at least one month. (See Table I)
- AHI per hour of sleep \> 5 and \<15, minimum SpO2 88, indicating mild obstructive sleep apnea).
- Average Nasal Congestion VAS of \> 3-10 indicating moderate to severe nasal congestion between visits 1 and 2 based on daily symptoms (average of 7...
You likely can't join if
- Presence of hypersensitivity to oxymetazoline or fluticasone propionate.
- people receiving allergen immunotherapy but not on a stable maintenance regimen for at least 30 days before the first study visit.
- If the subject has perennial allergic rhinitis, he/she should not be entered into this study eight weeks before, during, or six weeks after any...
- Women who are pregnant or lactating.
- Other known nasal diseases likely to affect deposition of oxymetazoline such as sinusitis, nasal polyps, or major nasal structural malformations.
- Respiratory tract infections in the last 14 days.
See the full eligibility criteria
- Male and female people 18 - 65 years of age.
- At least a one year history of perennial allergic or non-allergic rhinitis.
- people must be on the maximum recommended doses of one of the following NGCS for at least one month. (See Table I)
- AHI per hour of sleep \> 5 and \<15, minimum SpO2 88, indicating mild obstructive sleep apnea).
- Average Nasal Congestion VAS of \> 3-10 indicating moderate to severe nasal congestion between visits 1 and 2 based on daily symptoms (average of 7 scores).
- Average Congestion Quantifier 7 score of 7 between visits 1 and 2 based on weekly symptoms (average of 2 scores).
- Willingness to participate as indicated by signed informed consent.
- Presence of hypersensitivity to oxymetazoline or fluticasone propionate.
- people receiving allergen immunotherapy but not on a stable maintenance regimen for at least 30 days before the first study visit.
- If the subject has perennial allergic rhinitis, he/she should not be entered into this study eight weeks before, during, or six weeks after any seasonal exacerbation.
- Women who are pregnant or lactating.
- Other known nasal diseases likely to affect deposition of oxymetazoline such as sinusitis, nasal polyps, or major nasal structural malformations.
- Respiratory tract infections in the last 14 days.
- Infections requiring antibiotics in the last 14 days.
- Asthma or chronic obstructive pulmonary disease (COPD) requiring roflumilast or more than the recommended doses of inhaled corticosteroids, beta agonists, or antimuscarinic agents.
- No systemic glucocorticosteroids for one month prior or during the study.
- Cardiovascular disease with uncontrolled hypertension (BP160/80), arrhythmias and/or congestive heart failure.
- Insulin-dependent diabetes mellitus and/or diabetic retinopathy.
- people with mild OSA (AHI 5-14) and SpO2 \ 5 min during sleep that is identified during the screening portable sleep study.
- Hypertension requiring more than two drugs, with the exception of hydrochlorothiazide, to achieve control.
- A history of drug or alcohol abuse within the past 5 years.
- people who are currently abusing alcohol, illicit drugs, benzodiazepines, or narcotics.
- Inability to cooperate, comply with study procedures or communicate with the investigator to successfully complete the study.
- A history of benign prostate hypertrophy necessitating treatment.
- A history of psychiatric problems which, in the opinion of the investigators, would impair participation in the study.
- people with a planned hospitalization during the study.
- An infirmity, disability, or geographical location which seems likely to prevent regular attendance for subject visits.
- people with obstructive sleep apnea syndrome requiring CPAP therapy.
- people diagnosed with central sleep apnea (\> 5 central events per hour) or moderate to severe OSA (AHI \> 15) and SpO2 \ 5 min during sleep identified during screening.
- Use of the following medications within the time period specified below prior to Day -7 (Table 2).
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.