A Prospective Trial of Behavioral Therapy for Chronic Cough

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.

Study Overview

• Status: Unknown
• Conditions: Cough
• Intervention / Treatment: Behavioral: Voice Therapy; Behavioral: Voice Therapy and Heart Rate Variability Biofeedback; Behavioral: Heart Rate Variability Biofeedback

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philip Weissbrod, MD; Phone Number: 858-657-8590; Email: pweissbrod@ucsd.edu
• Study Contact Backup: Name: Erin Walsh, MA; Phone Number: 858-657-8590; Email: ehwalsh@ucsd.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92122
      • Recruiting
      • UCSD Center for Voice and Swallowing
      • Contact: Philip Weissbrod, MD; Phone Number: 858-657-8590; Email: pweissbrod@ucsd.edu
      • Contact: Erin Walsh, MA; Phone Number: 8586578590; Email: ehwalsh@ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Voice Therapy; (Group 1) will undergo active training in behavioral cough suppression and laryngeal relaxation exercises, but will not receive HRVB. Traditional cough suppression and laryngeal relaxation exercises include pursed lip breathing, swallowing (water, lozenge, gum, ice chips), sustained semi-occluded voicing, discussion and mitigation of triggers, maintaining a cough journal, addressing muscle tension dysphonia if indicated, and developing prophylaxis suppression and laryngeal relaxation based on stimulability. Participants in Group 1 will receive handwritten guidance indicating exercises to practice at home.	Behavioral: Voice Therapy; See Arm 1 & 2
ACTIVE_COMPARATOR: Voice Therapy and Heart Rate Variability Biofeedback; Voice therapy as described in Arm 1. HRVB involves measure respiratory rate, heart rate, body temperature and skin conductance. Participants are guided through reduced breathing rate until a resonant frequency is attained. HRVB breathing simulates resonance between the baroreflex rhythm and respiration based rhythm, increasing heart rate variability and baroreceptor sensitivity. Evidence suggests HRVB improves autonomic regularity. We propose this novel modality to address centrally regulated hypersensitivity that perpetuates coughing.	Behavioral: Voice Therapy and Heart Rate Variability Biofeedback; See Arm 2 & 3
ACTIVE_COMPARATOR: Heart Rate Variability Biofeedback; HRVB as indicated in Arm 2. No instruction will be provided for cough suppression, laryngeal desensitization, voice tasks or hygiene that traditionally reduces cough frequency and severity. This is the experimental arm.	Behavioral: Heart Rate Variability Biofeedback; See Arm 2 & 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Cough reduction	Measured by changes in cough severity index and patient recordings	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Durability of cough remediation	Phone call to patients	8 weeks
Changes in dyspnea	Measured by dyspnea index	3 weeks
Change in voice	Measured by voice handicap index	3 weeks

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: July 15, 2017
• First Submitted That Met QC Criteria: July 28, 2017
• First Posted (ACTUAL): August 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: 181207

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No