Laryngeal Cryotherapy for Refractory Neurogenic Cough

NCT05665244 | Recruiting DMC FDA Device

• 1 other identifier: STU-2022-0644
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Improved quality of life of patients suffering from chronic cough

  This is a validated patient reported outcome measure for chronic cough. This is a questionnaire of 10 questions about cough symptoms, each question is rated on a scale of 0-4 by the patient. The higher the CSI total score the worsen the cough symptoms are for the patient. The CSI will be compared across 5 time points (Pre-Laryngeal Cryotherapy, 1 week post cryotherapy, 1 month post cryotherapy, 3 months post cryotherapy and 6 months post cryotherapy) using repeated measures one-way ANOVA. Post-hoc pair-wise comparisons with Bonferroni correction will be used, as appropriate.

  2 years

• Pre and Post-time point differences.

  Sample size of 25 was determined based on expectations of a detectable significant within-group using a repeated measures ANOVA across 5 time points (add in the time points) with an alpha level of 0.0125, 85% power, and 1.246 effect size (based on previous work by Simpson et al PMID: 29668037.) needed to observe pre-post time point differences.

  2 years

Secondary Outcomes (1)

• Pre- and post-treatment measures for the cryotherapy treatment group

  2 years

Study Arms (1)

Upper airway cough syndrome

Procedure: Laryngeal cryotherapy; Device: Cryoprobe

Interventions

Laryngeal cryotherapy PROCEDURE

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.

Upper airway cough syndrome

Cryoprobe DEVICE

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

Upper airway cough syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult patients 18 years or older with diagnosis of neurogenic cough
• Negative workup for other causes, including sinonasal allergies/chronic sinusitis, cough-variant asthma, and GERD
• Patient willing to participate in a clinical trial

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

RECRUITING

Related Publications (11)

• Simpson CB, Amin MR. Chronic cough: state-of-the-art review. Otolaryngol Head Neck Surg. 2006 Apr;134(4):693-700. doi: 10.1016/j.otohns.2005.11.014.

  PMID: 16564398 BACKGROUND

• Gibson P, Wang G, McGarvey L, Vertigan AE, Altman KW, Birring SS; CHEST Expert Cough Panel. Treatment of Unexplained Chronic Cough: CHEST Guideline and Expert Panel Report. Chest. 2016 Jan;149(1):27-44. doi: 10.1378/chest.15-1496. Epub 2016 Jan 6.

  PMID: 26426314 BACKGROUND

• Farooqi MAM, Cheng V, Wahab M, Shahid I, O'Byrne PM, Satia I. Investigations and management of chronic cough: a 2020 update from the European Respiratory Society Chronic Cough Task Force. Pol Arch Intern Med. 2020 Sep 30;130(9):789-795. doi: 10.20452/pamw.15484. Epub 2020 Jul 6.

  PMID: 32627514 BACKGROUND

• Simpson CB, Tibbetts KM, Loochtan MJ, Dominguez LM. Treatment of chronic neurogenic cough with in-office superior laryngeal nerve block. Laryngoscope. 2018 Aug;128(8):1898-1903. doi: 10.1002/lary.27201. Epub 2018 Apr 18.

  PMID: 29668037 BACKGROUND

• Foote AG, Thibeault SL. Sensory Innervation of the Larynx and the Search for Mucosal Mechanoreceptors. J Speech Lang Hear Res. 2021 Feb 17;64(2):371-391. doi: 10.1044/2020_JSLHR-20-00350. Epub 2021 Jan 19.

  PMID: 33465318 BACKGROUND

• Strohl MP, Chang JL, Dwyer CD, Young VN, Rosen CA, Cheung SW. Laryngeal Adductor Reflex Movement Latency Following Tactile Stimulation. Otolaryngol Head Neck Surg. 2022 Apr;166(4):720-726. doi: 10.1177/01945998211025517. Epub 2021 Jul 13.

  PMID: 34253075 BACKGROUND

• Strohl MP, David AP, Dwyer CD, Rosen CA, Young VN, Chang JL, Cheung SW. Aesthesiometer-Based Testing for Laryngopharyngeal Hyposensitivity. Laryngoscope. 2022 Jan;132(1):163-168. doi: 10.1002/lary.29761. Epub 2021 Jul 20.

  PMID: 34289117 BACKGROUND

• Strohl MP, Young VN, Dwyer CD, Bhutada A, Crawford E, Chang JL, Rosen CA, Cheung SW. Novel Adaptation of a Validated Tactile Aesthesiometer to Evaluate Laryngopharyngeal Sensation. Laryngoscope. 2021 Jun;131(6):1324-1331. doi: 10.1002/lary.28947. Epub 2020 Jul 31.

  PMID: 32735711 BACKGROUND

• Aviv JE, Martin JH, Kim T, Sacco RL, Thomson JE, Diamond B, Close LG. Laryngopharyngeal sensory discrimination testing and the laryngeal adductor reflex. Ann Otol Rhinol Laryngol. 1999 Aug;108(8):725-30. doi: 10.1177/000348949910800802.

  PMID: 10453777 BACKGROUND

• Shembel AC, Rosen CA, Zullo TG, Gartner-Schmidt JL. Development and validation of the cough severity index: a severity index for chronic cough related to the upper airway. Laryngoscope. 2013 Aug;123(8):1931-6. doi: 10.1002/lary.23916. Epub 2013 Jun 4.

  PMID: 23737389 BACKGROUND

• DiBardino DM, Lanfranco AR, Haas AR. Bronchoscopic Cryotherapy. Clinical Applications of the Cryoprobe, Cryospray, and Cryoadhesion. Ann Am Thorac Soc. 2016 Aug;13(8):1405-15. doi: 10.1513/AnnalsATS.201601-062FR.

  PMID: 27268274 BACKGROUND

MeSH Terms

Conditions

upper airway cough syndrome

Study Officials

• Shumon Dhar, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shumon Dhar, MD

CONTACT

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

Paula Arellano-Cruz

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: December 27, 2022
• Study Start: December 26, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)