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Clinical Trials/NCT03235466
NCT03235466
Unknown
Not Applicable

A Prospective Trial of Behavioral Therapy for Chronic Cough

University of California, San Diego1 site in 1 country45 target enrollmentFebruary 1, 2018
ConditionsCough

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cough
Sponsor
University of California, San Diego
Enrollment
45
Locations
1
Primary Endpoint
Percentage of Cough reduction
Last Updated
5 years ago

Overview

Brief Summary

This study seeks to explore whether heart rate variability (HRV) biofeedback can be effective in the treatment of chronic cough. Chronic cough has many causes, including asthma, postnasal drip, and gastroesophageal reflux disease (GERD), each with a specific treatment. However, among a subset of cough patients, no clear cause is found despite extensive workup, and traditional treatment methods do not provide relief. Several studies revealed less common causes of chronic cough and disordered breathing such as vagal neuropathy, paradoxical vocal fold motion, and stress. Additional research identified links between the neurological networks that produce the cough reflex and those that maintain normal breathing. HRV biofeedback is a self-regulation technique that uses computer equipment to monitor heart rate and breathing, two key functions of the autonomic nervous system. By using this non-invasive behavioral technique, cough patients can regulate their breathing and autonomic function, potentially leading to improved autonomic balance and a reduction in cough symptoms.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
December 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Philip Weissbrod

Director, Center for Voice and Swallowing

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

  • 8+ weeks of cough, Fluent English speaker, Have access to an electronic mobile device

Exclusion Criteria

  • On neuromodulator therapy, cardiac arrhythmia, dysphagia, prior HRVB or mindfulness, head and neck surgery of the oropharynx, neck or larynx, lung surgery, pulmonary pathology other than asthma, tourette syndrome, ACE inhibitor use, current or recent smoker.
  • Added exclusion criteria as of March 2020 - history of COVID+.

Outcomes

Primary Outcomes

Percentage of Cough reduction

Time Frame: 3 weeks

Measured by changes in cough severity index and patient recordings

Secondary Outcomes

  • Durability of cough remediation(8 weeks)
  • Changes in dyspnea(3 weeks)
  • Change in voice(3 weeks)

Study Sites (1)

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