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A Prospective Trial of Behavioral Therapy for Chronic Cough

Primary Purpose

Cough

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Voice Therapy
Voice Therapy and Heart Rate Variability Biofeedback
Heart Rate Variability Biofeedback
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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+.

Sites / Locations

  • UCSD Center for Voice and SwallowingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Voice Therapy

Voice Therapy and Heart Rate Variability Biofeedback

Heart Rate Variability Biofeedback

Arm Description

(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.

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Cough reduction
Measured by changes in cough severity index and patient recordings

Secondary Outcome Measures

Durability of cough remediation
Phone call to patients
Changes in dyspnea
Measured by dyspnea index
Change in voice
Measured by voice handicap index

Full Information

First Posted
July 15, 2017
Last Updated
December 3, 2020
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT03235466
Brief Title
A Prospective Trial of Behavioral Therapy for Chronic Cough
Official Title
A Prospective Trial of Behavioral Therapy for Chronic Cough
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Voice Therapy
Arm Type
Active Comparator
Arm Description
(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.
Arm Title
Voice Therapy and Heart Rate Variability Biofeedback
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Heart Rate Variability Biofeedback
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Voice Therapy
Intervention Description
See Arm 1 & 2
Intervention Type
Behavioral
Intervention Name(s)
Voice Therapy and Heart Rate Variability Biofeedback
Intervention Description
See Arm 2 & 3
Intervention Type
Behavioral
Intervention Name(s)
Heart Rate Variability Biofeedback
Intervention Description
See Arm 2 & 3
Primary Outcome Measure Information:
Title
Percentage of Cough reduction
Description
Measured by changes in cough severity index and patient recordings
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Durability of cough remediation
Description
Phone call to patients
Time Frame
8 weeks
Title
Changes in dyspnea
Description
Measured by dyspnea index
Time Frame
3 weeks
Title
Change in voice
Description
Measured by voice handicap index
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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. Added exclusion criteria as of March 2020 - history of COVID+.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Weissbrod, MD
Phone
858-657-8590
Email
pweissbrod@ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Walsh, MA
Phone
858-657-8590
Email
ehwalsh@ucsd.edu
Facility Information:
Facility Name
UCSD Center for Voice and Swallowing
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Weissbrod, MD
Phone
858-657-8590
Email
pweissbrod@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Erin Walsh, MA
Phone
8586578590
Email
ehwalsh@ucsd.edu

12. IPD Sharing Statement

Learn more about this trial

A Prospective Trial of Behavioral Therapy for Chronic Cough

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