A Prospective Trial of Behavioral Therapy for Chronic Cough

Not Applicable

• Conditions: Cough

• Registration Number: NCT03235466
• Lead Sponsor: University of California, San Diego

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-15
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-01
• Study Start: 2018-02-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-04
• Primary Completion: 2021-06-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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+.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of Cough reduction	3 weeks	Measured by changes in cough severity index and patient recordings

Secondary Outcome Measures

Name	Time	Method
Durability of cough remediation	8 weeks	Phone call to patients
Changes in dyspnea	3 weeks	Measured by dyspnea index
Change in voice	3 weeks	Measured by voice handicap index

Trial Locations

Locations (1)

UCSD Center for Voice and Swallowing; 🇺🇸 San Diego, California, United States