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A Prospective Trial of Behavioral Therapy for Chronic Cough

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ClinicalTrials.gov Identifier: NCT03235466
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Philip Weissbrod, 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.

Condition or disease Intervention/treatment Phase
Cough Behavioral: Voice Therapy Behavioral: Voice Therapy and Heart Rate Variability Biofeedback Behavioral: Heart Rate Variability Biofeedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial of 3 groups: 1) standard voice therapy 2) voice therapy and heart rate variability biofeedback and 3) heart rate variability biofeedback
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Trial of Behavioral Therapy for Chronic Cough
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

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




Primary Outcome Measures :
  1. Percentage of Cough reduction [ Time Frame: 3 weeks ]
    Measured by changes in cough severity index and patient recordings


Secondary Outcome Measures :
  1. Durability of cough remediation [ Time Frame: 8 weeks ]
    Phone call to patients

  2. Changes in dyspnea [ Time Frame: 3 weeks ]
    Measured by dyspnea index

  3. Change in voice [ Time Frame: 3 weeks ]
    Measured by voice handicap index



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235466


Contacts
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Contact: Philip Weissbrod, MD 858-657-8590 pweissbrod@ucsd.edu
Contact: Erin Walsh, MA 858-657-8590 ehwalsh@ucsd.edu

Locations
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United States, California
UCSD Center for Voice and Swallowing Recruiting
San Diego, California, United States, 92122
Contact: Philip Weissbrod, MD    858-657-8590    pweissbrod@ucsd.edu   
Contact: Erin Walsh, MA    8586578590    ehwalsh@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego

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Responsible Party: Philip Weissbrod, Director, Center for Voice and Swallowing, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03235466     History of Changes
Other Study ID Numbers: 170581
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms