Efficacy of SLN Block for Chronic Cough

Not Applicable

Completed

• Conditions: Superior Laryngeal Nerve Block; Cough; Neurogenic Cough

• Registration Number: NCT04421092
• Lead Sponsor: Medical University of South Carolina

Brief Summary

This is a research study to find out if superior laryngeal nerve blocks are an effective way to reduce cough when compared to placebo (a substance without any medical value). Eligibility for the study include the following: age \>18, cough history suggestive that the nerve to the voice box is overactive, non-smoker, Patients will be followed over time and assigned to either the treatment or placebo group at random. The treatment would be four superior laryngeal nerve blocks and the placebo would be four saline injections (the inactive substance). Study team will measure if the injection improved cough and ask patients to keep a log of symptoms and fill out questionnaires at each visit. After the four injections, patients will follow up in 3 months to see if cough has returned and if so, how severe the cough is.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2020-07-22
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Results First Submitted: 2023-12-26
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Results First Posted: 2025-10-23
• Last Update Posted: 2025-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• History consistent with neurogenic cough
• Exclusion of other etiologies (see exclusion criteria)
• Age ≥ 18

Exclusion Criteria

• Current neuromodulating medication use
• Untreated other etiologies of cough:

Current smoker Current ACE/ARB use Abnormal PFTs within 6 months Uncontrolled OSA Abnormal CXR within 6 months RSI > 13 or RFS >11 AND workup positive for GERD (esophagram, 24-hour pH probe, manometry, EGD)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Cough Severity	Change from Baseline to 3 months	Patient will complete the Leicester Cough Questionnaire at each visit. This is a validated survey that measures 3 domains (physical, psychological and social). The total score range is 3-21 and domain scores range from 1-7; a higher score indicates a better quality of life.

Secondary Outcome Measures

Name	Time	Method
Subjective Improvement in Cough	Baseline, 1-4 weeks post-injection, and 3 months post-treatment	Improvement was defined as a 'yes' response at any time point during the study (1-4 weeks or 3 months post-treatment). The reported value reflects the total number of participants who reported improvement at any time point.
Summed Daily Change in Subjective Cough Severity	Daily for 3 months post-injection	Participants rate cough severity on a 0-15 visual analogue scale. Scores are recorded daily and analyzed using regression. Higher scores indicate greater severity. VAS is a 0-15 scale completed daily by participants.; Severity is measured using a ruler to determine percentage along the scale. Scores were analyzed using regression models to assess trends over time.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States