A Prospective Trial of Behavioral Therapy for Chronic Cough

NCT ID: NCT03235466

Last Updated: 2020-12-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2021-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Voice Therapy

Intervention Type: BEHAVIORAL

See Arm 1 \& 2

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.

Group Type: ACTIVE_COMPARATOR

Voice Therapy and Heart Rate Variability Biofeedback

Intervention Type: BEHAVIORAL

See Arm 2 \& 3

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.

Group Type: ACTIVE_COMPARATOR

Heart Rate Variability Biofeedback

Intervention Type: BEHAVIORAL

See Arm 2 \& 3

Interventions

Voice Therapy

See Arm 1 \& 2

Intervention Type: BEHAVIORAL

Voice Therapy and Heart Rate Variability Biofeedback

See Arm 2 \& 3

Intervention Type: BEHAVIORAL

Heart Rate Variability Biofeedback

See Arm 2 \& 3

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Philip Weissbrod

Director, Center for Voice and Swallowing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCSD Center for Voice and Swallowing

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Philip Weissbrod, MD

Role: CONTACT

pweissbrod@ucsd.edu

858-657-8590

Erin Walsh, MA

Role: CONTACT

ehwalsh@ucsd.edu

858-657-8590

Facility Contacts

Philip Weissbrod, MD

Role: primary

pweissbrod@ucsd.edu

858-657-8590

Erin Walsh, MA

Role: backup

ehwalsh@ucsd.edu

8586578590

Other Identifiers

181207

Identifier Type: -

Identifier Source: org_study_id