Clinical trial: Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing (NCT03850197)

Eligibility criteria:
INCLUSION CRITERIA

        ETD participants:

          -  Bilaterally intact tympanic membranes

          -  aged 5 to 60; generally good health

          -  ability to understand and give informed consent

          -  history of myringotomy tubes, recurrent middle ear infections, recurrent middle ear
             fluids, or prior ETD diagnosis

          -  ability to perform maneuvers that will be done during the testing protocol.

        Control participants

          -  Bilaterally intact tympanic membranes

          -  aged 5 to 60

          -  generally good health

          -  ability to understand and give informed consent

          -  no personal history of recurrent otitis media or other middle--ear disease

          -  ability to perform maneuvers that will be done during the testing protocol

          -  no difficulty equalizing middle--ear pressures in daily life.

        EXCLUSION CRITERIA

        ETD participants:

          -  Cold/allergic rhinitis (temporary) on presentation

          -  current dental problem or dental work within 7 days (temporary)

          -  history of ossicular reconstruction

          -  history of tympanoplasty

          -  syndromes predisposing to otitis media

          -  extant middle--ear disease

          -  inability to complete testing protocols

          -  tympanic membrane perforation

          -  abnormal tympanogram (type B tympanogram)

          -  BMI >40

          -  history of congenital heart disease

          -  prior radiation to head and neck

          -  uncontrolled respiratory disease

          -  any medical condition or use of medication for which the study physician feels study
             procedures would not be in the subject's best interest.

          -  In adults, a positive urine pregnancy test (in females), blood pressure above 140/90,
             glaucoma, and sensitivity to drugs used to prepare the nose for endoscopic examination
             will also exclude potential participants.

        Control participants:

          -  (in addition to above) significant middle--ear disease history

          -  evidence of middle ear pathology.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 5 Years old.
Subject must be at most 60 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction