A Prospective Trial of Behavioral Therapy for Chronic Cough

NCT03235466 | Unknown

• 1 other identifier: 181207
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough

Outcome Measures

Primary Outcomes (1)

• Percentage of Cough reduction

  Measured by changes in cough severity index and patient recordings

  3 weeks

Secondary Outcomes (3)

• Durability of cough remediation

  8 weeks

• Changes in dyspnea

  3 weeks

• Change in voice

  3 weeks

Study Arms (3)

Voice Therapy

ACTIVE COMPARATOR

(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

Voice Therapy and Heart Rate Variability Biofeedback

ACTIVE COMPARATOR

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

Heart Rate Variability Biofeedback

ACTIVE COMPARATOR

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

Interventions

Voice Therapy BEHAVIORAL

See Arm 1 \& 2

Voice Therapy

Voice Therapy and Heart Rate Variability Biofeedback BEHAVIORAL

See Arm 2 \& 3

Voice Therapy and Heart Rate Variability Biofeedback

Heart Rate Variability Biofeedback BEHAVIORAL

See Arm 2 \& 3

Heart Rate Variability Biofeedback

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Center for Voice and Swallowing

San Diego, California, 92122, United States

RECRUITING

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Philip Weissbrod, MD

CONTACT

858-657-8590; pweissbrod@ucsd.edu

Erin Walsh, MA

CONTACT

858-657-8590; ehwalsh@ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Voice and Swallowing

Model Details: Randomized controlled trial of 3 groups: 1) standard voice therapy 2) voice therapy and heart rate variability biofeedback and 3) heart rate variability biofeedback

Study Record Dates

• First Submitted: July 15, 2017
• First Posted: August 1, 2017
• Study Start: February 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 4, 2020

Record last verified: 2020-12

Locations

US (1)