Ear, Nose & Throat

Otolaryngology Clinical Trials

Our Clinical Trials

The following is a list of the ongoing clinical trials in the department of Otolaryngology-Head & Neck Surgery. If you are interested in learning more about a trial, or would like to be a participant in the trial, please contact the trial coordinator at the number or email listed. If you have questions about our research or a clinical trial, please contact us the Otolaryngology ENT Clinic. Each division may have ongoing clinical trials. This page is kept up to date, but trials may close with little or no notice. 

Click on the Division noted below to jump to the clinical trials that are ongoing for that group:

Pediatric Clinical Trials

The Pediatric Division of the Department of Otolaryngology-Head & Neck Surgery is currently working on the following clinical trials:

  • Genetics of ear infections (otitis media)
  • Outcomes of procedures for laryngeal cleft repair for pediatric patients with dysphagia
  • Outcomes of tympanostomy tubes for patients with Down syndrome
  • Treatment outcomes in children with hypernasal speech (velopharyngeal insufficiency)
  • How children's ears are affected by cleft palate

If you are interested in finding out more about any of these studies, or if you are interested in participating in one of these studies, please call 503-494-5350 to schedule a consultation with either Dr. MacArthur or Dr. Milczuk in our Pediatric Otolaryngology clinic. If you would like to know if you are eligible to participate in a study, please email Dr MacArthur.

Inspire implant for obstructive sleep apnea in children and young adults with Down syndrome

Title: A pilot study to evaluate safety and efficacy of the hypoglossal nerve stimulator in adolescents with Down Syndrome and obstructive sleep apnea (IRB STUDY00018588) 

Funder: Inspire Medical Systems, Inc.  

Description:  Many people suffer from a disorder called obstructive sleep apnea, which occurs when the airway is blocked during sleep and causes difficulty breathing. By stimulating a nerve under the chin, called the hypoglossal nerve, with mild electrical stimulation, the tongue is lifted up from the back of the throat. This process can help to reopen the airway in carefully selected individuals with sleep apnea. The Inspire® System is a hypoglossal nerve stimulation system that improves moderate to severe obstructive sleep apnea syndrome symptoms in carefully selected adults. It is FDA approved for use in the adult population. 

The primary object of this pilot study is to evaluate the safety of the Inspire® Upper Airway Simulation System, Model 3028 IPG, in adolescents and young adults (age 10-21) with Down Syndrome and moderate to severe obstructive sleep apnea.

The secondary objective of this pilot study is to determine if hypoglossal nerve stimulation improves quality of life and objective measures of airway obstruction during sleep in adolescents with Down syndrome. 

Children and adults with Down syndrome, ages 10 to 21 years of age, who have already had their tonsils removed are eligible to participate. Participants must also have a BMI of less than 95th percentile for their age.  

Role: Dr. Derek Lam. Principal investigator. 

If you are interested in finding more about this study please call 503 494-3569 or email Pediatric ENT Research.

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Oregon Sinus Center

Title: Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis

Study Dates: 7/1/2016 - 6/30/2021

Funding Source: National Institute on Deafness and Other Communication Disorders, one of the National Institutes of Health (Bethesda, MD), Federal Identification #3R01-DC005805

National Registry:  Determinants of Olfactory Dysfunction in Chronic Rhinosinusitis

Description: A multi-institutional prospective cohort study to compare improvements in olfactory function and quality of life following either continued medical management or endoscopic sinus surgery for chronic rhinosinusitis. Approximately 1,000 patients will be enrolled at several tertiary care centers around the country and coordinated at OHSU. This minimal risk study evaluates both olfactory function and quality of life over a 6 month trial period in our patients diagnosed with chronic sinusitis, and measures the cellular and molecular expression of inflammatory markers from the olfactory cleft in order to identify risk factors associated with olfactory loss in our patients.

Principal Investigator(s): Timothy L. Smith, MD, MPH; Zachary M. Soler, MD, MSc

Enrollment Opportunities: The Oregon Sinus Center at OHSU is the coordinating research center and all enrollment activities take place within the Oregon Sinus Center at the Center for Health and Healing in Portland, Oregon during normal clinic visits by invitation only. To date, other patient enrollment sites in the United States include the Medical University of South Carolina (Charleston, SC.), University of Utah (Salt Lake City, UT.), the University of Colorado (Aurora, CO.), and the University of Virginia (Charlottesville, VA.).

Contact: Dr. Timothy L. Smith, Professor, or Jess C. Mace, Research Coordinator at (503) 494-5886.

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Facial Plastic and Reconstructive Surgery

Facial paralysis clinical trial

Dates: 9/2017 to 5/2019

Title: Facial electrical stimulation to promote recovery in patients with facial paralysis from Bell's palsy (IRB 16901)

Source: Medical Research Foundation of Oregon 

Description: A randomized placebo controlled trial to compare the effectiveness of electric stimulation of the face in recovery of patients with poor prognosis for recovery from Bell's palsy.
Patients with complete paralysis and over 60 years of age are eligible to participate.
Electric stimulation is done at home with the equipment we provide.  

Role: Dr. Myriam Loyo. Principal investigator 

If you are interested in finding more about this study please call 503 494-5678 or email Myriam Loyo, MD.

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