Laryngeal Cryotherapy for Refractory Neurogenic Cough

Официальное название

To Determine the Efficacy of Topical Cryotherapy on Supraglottic Laryngeal Mucosa in the Treatment of Chronic Neurogenic Cough in Adult Patients

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура 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.
• Устройство Cryoprobe
  Cryoprobe is FDA approved for use for the destruction of unwanted tissue along the respiratory tract

Первичные конечные точки

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

Вторичные конечные точки (1)

• Pre- and post-treatment measures for the cryotherapy treatment group [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 1 центр

• UT Southwestern Medical Center — Dallas

Публикации

• 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

Идентификаторы

NCT: NCT05665244 · STU-2022-0644

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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