Clinical trial NCT05665244: Laryngeal Cryotherapy for Refractory Neurogenic Cough
Official title: To Determine the Efficacy of Topical Cryotherapy on Supraglottic Laryngeal Mucosa in the Treatment of Chronic Neurogenic Cough in Adult Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Upper-Airway Cough Syndrome
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study involves patient with eurogenic cough is a diagnosis of exclusion applied to persistent cough (8 weeks or longer) and of the age 18 years or older.

Brief summary: 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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Improved quality of life of patients suffering from chronic cough
timeFrame: 2 years
measure: Pre and Post-time point differences.
timeFrame: 2 years
Secondary outcomes:
measure: Pre- and post-treatment measures for the cryotherapy treatment group
timeFrame: 2 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References:
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