Sinus Symptoms
Research Study

Researchers at Virginia Commonwealth University are conducting the NOSES study to learn which treatments work best for adults experiencing acute sinusitis, such as nasal congestion, facial pressure, headaches, and nasal drainage. By participating, you can help us improve care and treatment recommendations for future patients with sinus infections.

Fast Facts

Sinus Symptoms
3 weeks or less

Ages
18-75

Compensation
available

Conducted remotely across Central Virginia

Additional Information

Help us find the best treatment for sinusitis.

Sinusitis is common, uncomfortable, and often treated with antibiotics that may not always be necessary.

Sinusitis, sometimes called a “head cold”, causes swelling in the tissues of the nose and face, leading to symptoms like congestion, facial pressure, headache, and fatigue. While antibiotics are frequently prescribed, many cases of sinusitis improve without them, and unnecessary antibiotic use can lead to side effects, allergic reactions, and antibiotic resistance.

The NOSES Study aims to better understand how sinusitis improves over time and which treatments are most effective. By participating, you can help researchers improve future care for sinusitis while receiving close symptom monitoring, standard over-the-counter care guidance, and possible additional treatment if symptoms persist.

You may be eligible for this study if you meet the following criteria.

Inclusion Criteria:

  • You’re between the ages of 18 and 75
  • You’re experiencing one or more sinus-related symptoms at study start
    • Face or forehead pain or pressure
    • Nasal congestion
    • Runny nose
    • Reduced sense of smell
    • Fever less than 102°F
    • Headache
    • Bad-smelling breath
    • Feeling tired
    • Ear pain or pressure
    • Tooth pain
  • You’ve had any of these symptoms for less than three weeks
  • You live within a 40-mile radius of Richmond, VA (zip code 23219)
  • The study clinician confirms you meet eligibility during a brief telehealth visit

Some Exclusion Criteria:

  • Currently pregnant or breastfeeding
  • Received antibiotic treatment within the past 4 weeks
  • Allergy or intolerance to penicillin
  • Prior sinus surgery (cosmetic surgery such as rhinoplasty, septal deviation, etc. are not exclusionary)
  • Complications of rhinosinusitis
  • Presence of a comorbidity or medication that may impair your immune response
  • Current use of an intranasal corticosteroid (steroid nasal spray) without willingness to discontinue use for the duration of the study

Screening

  • You’ll speak with a member of the study team and a study doctor to complete brief phone screenings to determine if you are eligible and a good candidate for the study.

If you meet eligibility and decide to enroll in the NOSES Study, you will be in the study for up to

21 days depending on how many days you have been experiencing sinus symptoms at enrollment.

Enrollment

  • Meet with a study team member to review study consent form either virtually (over Zoom) or in person.
  • Complete a brief questionnaire
  • A study team member delivers the nasal wash kit and $20 compensation. They will also complete a finger stick to collect a small blood sample and a temperature check.

Participation

  • Complete a brief, 2-minute daily symptom diary via text or email.
  • Use the nasal wash kit to rinse out your sinuses (as needed).
  • Use over-the-counter medications, as discussed with your clinician.
  • Complete a brief check-in call with a study team member to assess your symptoms at Day 9
  • If you are still sick (or you have been sick) for more than 9 days, you may receive additional treatment(s) delivered to you.  You may be randomly assigned to receive one of the following treatment groups:
    • Antibiotics
    • Antibiotics and a steroid nasal spray
    • Placebo antibiotics
    • Placebo antibiotics and a steroid nasal spray

Compensation is available for participating, including:

  • $20 for enrollment

  • $20 for symptom check-in or treatment randomization

  • Additional compensation for completing other study activities

There is no cost for you to participate in our research study. All study activities can be completed remotely via Zoom, phone calls, and/or email. Study team members can deliver study supplies to participants.

This study has been reviewed and approved by BRANY IRB (PLACER-2021C3-24476)