Upper-Airway Cough SyndromeNCT05665244
Laryngeal Cryotherapy for Refractory Neurogenic Cough
An observational study of Upper-Airway Cough Syndrome, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper-Airway Cough Syndrome
- What is being tested?
- Laryngeal cryotherapy and Cryoprobe
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2022to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75235
Shumon Dhar, MD
Paula Arellano-Cruz, 2146488096, OTOresearch@utsouthwestern.edu
About this study
Official title: 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
Read the 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.
- Conditions
- Upper-Airway Cough Syndrome
- Being tested
- Laryngeal cryotherapy, Cryoprobe
- Medical subject headings
- upper airway cough syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngeal cryotherapyProcedure or surgery
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.
CryoprobeDevice
Cryoprobe is FDA approved for use for the destruction of unwanted tissue along the respiratory tract
| Study group | Role | What they receive |
|---|---|---|
| Upper airway cough syndrome | Not described Receives: Procedure: Laryngeal cryotherapy; Device: Cryoprobe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved quality of life of patients suffering from chronic cough
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.
Measured: 2 years
Pre and Post-time point differences.
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.
Measured: 2 years
Secondary outcomes (1)
Pre- and post-treatment measures for the cryotherapy treatment group
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start26 Dec 2022
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Upper-Airway Cough SyndromeStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shumon Dhar, MD, University of Texas Southwestern Medical Center
- Investigators
- Shumon Dhar, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665244
- Sponsor's protocol ID
- STU-2022-0644
- Status last verified
- Jan 2026
- First submitted
- 1 Dec 2022
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 16564398Gibson 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.
PubMed 26426314Farooqi 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.
PubMed 32627514Simpson 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.
PubMed 29668037Foote 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.
PubMed 33465318Strohl 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.
PubMed 34253075Strohl 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.
PubMed 34289117Strohl 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.
PubMed 32735711Aviv 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.
PubMed 10453777Shembel 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.
PubMed 23737389DiBardino 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.
PubMed 27268274
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Determine the Efficacy of Topical Cryotherapy on Supraglottic Laryngeal Mucosa in the Treatment of Chronic Neurogenic Cough in Adult Patients
- ClinicalTrials.gov ID
- NCT05665244
- Acronym / sponsor ID
- STU-2022-0644
- Conditions
- Upper-Airway Cough Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper airway cough syndrome | – | Procedure: Laryngeal cryotherapy, Device: Cryoprobe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laryngeal cryotherapyLaryngeal 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. | Procedure or surgery | Upper airway cough syndrome |
| CryoprobeCryoprobe is FDA approved for use for the destruction of unwanted tissue along the respiratory tract | Device | Upper airway cough syndrome |
Primary outcome
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.
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.
1 secondary outcome
Pre- and post-treatment measures for the cryotherapy treatment group
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Background: PubMed 16564398Simpson 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.
- Background: PubMed 26426314Gibson 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.
- Background: PubMed 32627514Farooqi 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.
- Background: PubMed 29668037Simpson 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.
- Background: PubMed 33465318Foote 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.
- Background: PubMed 34253075Strohl 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.
- Background: PubMed 34289117Strohl 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.
- Background: PubMed 32735711Strohl 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.
- Background: PubMed 10453777Aviv 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.
- Background: PubMed 23737389Shembel 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.
- Background: PubMed 27268274DiBardino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shumon Dhar, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper-Airway Cough Syndrome, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shumon Dhar, MD (214-645-7034, Shumon.Dhar@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved quality of life of patients suffering from chronic cough (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05665244, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.