Laryngeal Cryotherapy for Refractory Neurogenic Cough

NCT ID: NCT05665244

Last Updated: 2026-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-26

Study Completion Date

2027-02-28

Brief Summary

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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

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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.

Conditions

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Upper-Airway Cough Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Upper airway cough syndrome

Laryngeal cryotherapy

Intervention Type 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.

Cryoprobe

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type PROCEDURE

Cryoprobe

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

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shumon Dhar, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shumon Dhar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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UT Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shumon Dhar, MD

Role: CONTACT

214-645-7034

Paula Arellano-Cruz

Role: CONTACT

214-648-8096

Facility Contacts

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Shumon Dhar, MD

Role: primary

Paula Arellano-Cruz

Role: backup

2146488096

References

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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.

Reference Type BACKGROUND
PMID: 16564398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26426314 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32627514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29668037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33465318 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34253075 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34289117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32735711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10453777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23737389 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27268274 (View on PubMed)

Other Identifiers

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STU-2022-0644

Identifier Type: -

Identifier Source: org_study_id

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