Recruiting

Laryngeal Cryotherapy

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT05665244

Conditions

Upper-Airway Cough Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Laryngeal cryotherapy

Cryoprobe

Study Details

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

Conditions

Upper-Airway Cough Syndrome

Study ID

NCT05665244

Start date

Dec 26, 2022

Status verified date

Jan, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

28 participants

Anticipated

Interventions and Outcome Measures

Arms

Upper airway cough syndrome

Interventions

Laryngeal cryotherapy

Laryngeal cryotherapy is the therapeutic freezing of tissue in the throat to numb the overactive sensory nerves in the throat. This technique is believed to reduce cough symptoms in this study.

Cryoprobe

Cryoprobe is FDA approved for use for the destruction of unwanted tissue along the respiratory tract

Primary outcome measure

  • Improved quality of life of patients suffering from chronic cough [ Time Frame: 2 years ]
  • Pre and Post-time point differences. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Shumon Dhar, MD

214-645-7034Shumon.Dhar@UTSouthwestern.edu

Paula Arellano-Cruz

214-648-8096Paula.Arellano-Cruz@UTSouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75235

Contacts

Paula Arellano-Cruz

2146488096OTOresearch@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-01-30.