Study Results
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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RECRUITING
28 participants
OBSERVATIONAL
2022-12-26
2027-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Upper airway cough syndrome
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
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.
Cryoprobe
Cryoprobe is FDA approved for use for the destruction of unwanted tissue along the respiratory tract
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Shumon Dhar, MD
Assistant Professor
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
Countries
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Central Contacts
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Facility Contacts
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Shumon Dhar, MD
Role: primary
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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STU-2022-0644
Identifier Type: -
Identifier Source: org_study_id
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