Laryngeal Cryotherapy for Refractory Neurogenic Cough
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laryngeal cryotherapy, Cryoprobe.
- Who it may be relevant to
- Registry conditions: Upper-Airway Cough Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
To Determine the Efficacy of Topical Cryotherapy on Supraglottic Laryngeal Mucosa in the Treatment of Chronic Neurogenic Cough in Adult Patients
Overview
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.
Interventions
- Procedure 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. - Device Cryoprobe
Cryoprobe is FDA approved for use for the destruction of unwanted tissue along the respiratory tract
Primary outcome measures
- Improved quality of life of patients suffering from chronic cough [Time frame: 2 years]
- Pre and Post-time point differences. [Time frame: 2 years]
Secondary outcome measures (1)
- Pre- and post-treatment measures for the cryotherapy treatment group [Time frame: 2 years]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- UT Southwestern Medical Center — Dallas
Publications
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Identifiers
NCT: NCT05665244 · STU-2022-0644