A Prospective Trial of Behavioral Therapy for Chronic Cough

Cough Clinical Trial

Official title:

A Prospective Trial of Behavioral Therapy for Chronic Cough

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03235466
• Other study ID #: 181207
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2020
• Source: University of California, San Diego
• Contact: Philip Weissbrod, MD
• Phone: 858-657-8590
• Email: pweissbrod[@]ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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+.

Related Conditions & MeSH terms

• Cough

Intervention

Behavioral:
• Voice Therapy
See Arm 1 & 2
• Voice Therapy and Heart Rate Variability Biofeedback
See Arm 2 & 3
• Heart Rate Variability Biofeedback
See Arm 2 & 3

Locations

Country	Name	City	State
United States	UCSD Center for Voice and Swallowing	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Cough reduction	Measured by changes in cough severity index and patient recordings	3 weeks
Secondary	Durability of cough remediation	Phone call to patients	8 weeks
Secondary	Changes in dyspnea	Measured by dyspnea index	3 weeks
Secondary	Change in voice	Measured by voice handicap index	3 weeks