Laryngeal Cryotherapy for Refractory Neurogenic Cough

The University of Texas System (UT)

Status: Enrolling

Conditions: Upper-Airway Cough Syndrome

Treatments: Procedure: Laryngeal cryotherapy; Device: Cryoprobe

Study type: Observational

Funder types: Other

Identifiers

NCT05665244

Cryotherapy

Details and patient eligibility

About

This study aims to evaluate the safety and efficacy of upper aerodigestive tract cryotherapy treatment in patients with refractory neurogenic cough in a prospective pilot study with a validated patient reported outcome measure

Full description

This study aims to test a new type of treatment for patients suffering from chronic cough, also known as upper airway cough syndrome. The new treatment involves the use of laryngeal cryotherapy which is the therapeutic freezing of tissue in the throat to numb the overactive sensory nerves in the throat which is believed to reduce cough symptoms. Patients will first undergo a flexible scope of the throat (laryngoscopy) to test for hypersensitive areas in the throat, then undergo the cryotherapy procedure in the office. After that, patients will be followed up in the clinic with the usual standard of care visits and undergo validated cough surveys to track their cough symptoms after the procedure. Possible side effects to this procedure are listed in detail below, and include temporary throat pain and coughing.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients 18 years or older with diagnosis of neurogenic cough
• Neurogenic cough is a diagnosis of exclusion applied to persistent cough (8 weeks or longer)
• Negative workup for other causes, including sinonasal allergies/chronic sinusitis, cough-variant asthma, and GERD
• Patient willing to participate in a clinical trial

Exclusion criteria

• Uncontrolled reflux (scoring on Reflux Symptom index of 13 or higher)
• Vocal fold abnormalities or impairment
• History of asthma or other underlying lung condition not adequately treated or controlled
• Uncontrolled Allergic Rhinitis (Total Nasal Symptom Score >6, which would indicate moderate disease32)
• Reported symptom of postnasal drip
• Current smoker
• Current neuromodulator medication use
• Patient unwilling to participate in clinical trial or sign an informed consent
• End stage medical disease with poor life expectancy
• Medical instability deemed by the investigators as a contraindication for enrollment
• Abnormal Chest X-ray
• Abnormal pulmonary function testing (PFTs)
• Positive local allergy panel (combined RAST testing)

Trial design

25 participants in 1 patient group

Upper airway cough syndrome

Treatment:

Device: Cryoprobe

Procedure: Laryngeal cryotherapy