Laryngeal Cryotherapy for Refractory Neurogenic Cough

January 15, 2024 updated by: Shumon Dhar, MD, University of Texas Southwestern Medical Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Upper airway cough syndrome
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved quality of life of patients suffering from chronic cough
Time Frame: 2 years
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.
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre- and post-treatment measures for the cryotherapy treatment group
Time Frame: 2 years
This measure is the pre cryotherapy and 1 week post cryotherapy laryngeal aesthesiometer testing. This is a type of validated sensory testing of the larynx performed during an office flexible laryngoscopy where calibrated monofilaments are used to assess how sensitive certain parts of the larynx are. The data collected will be if a specific monofilament (size 6-0, 5-0, and 4-0) can trigger or not trigger a cough reflex when applied to specific subsites of the larynx (aryepiglottic fold, laryngeal aspect of epiglottis, false vocal fold, arytenoid prominence, and lateral and medial piriform sinus
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2022

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

December 1, 2022

First Submitted That Met QC Criteria

December 16, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cryotherapy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Upper-Airway Cough Syndrome

Clinical Trials on Laryngeal cryotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe