CoughNCT03235466
A Prospective Trial of Behavioral Therapy for Chronic Cough
A study testing Voice Therapy, Voice Therapy and Heart Rate Variability Biofeedback and Heart Rate Variability Biofeedback in people with Cough, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cough
- What is being tested?
- Voice Therapy, Voice Therapy and Heart Rate Variability Biofeedback and Heart Rate Variability Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 8+ weeks of cough, Fluent English speaker, Have access to an electronic mobile device
Who cannot join
- 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+.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
UCSD Center for Voice and Swallowing
San Diego, California, 92122
Philip Weissbrod, MD, 858-657-8590, pweissbrod@ucsd.edu
Erin Walsh, MA, 8586578590, ehwalsh@ucsd.edu
About this study
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
- Being tested
- Voice Therapy, Voice Therapy and Heart Rate Variability Biofeedback, Heart Rate Variability Biofeedback
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice TherapyBehavioural
See Arm 1 \& 2
Voice Therapy and Heart Rate Variability BiofeedbackBehavioural
See Arm 2 \& 3
Heart Rate Variability BiofeedbackBehavioural
See Arm 2 \& 3
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Heart Rate Variability Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Cough reduction
Measured by changes in cough severity index and patient recordings
Measured: 3 weeks
Secondary outcomes (3)
Durability of cough remediation
Phone call to patients
Measured: 8 weeks
Changes in dyspnea
Measured by dyspnea index
Measured: 3 weeks
Change in voice
Measured by voice handicap index
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start1 Feb 2018
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Weissbrod, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235466
- Sponsor's protocol ID
- 181207
- Status last verified
- Dec 2020
- First submitted
- 15 Jul 2017
- Last updated
- 4 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial of Behavioral Therapy for Chronic Cough
- ClinicalTrials.gov ID
- NCT03235466
- Acronym / sponsor ID
- 181207
- Conditions
- Cough
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Voice Therapy | Active comparator | Behavioral: 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. |
| Voice Therapy and Heart Rate Variability Biofeedback | Active comparator | Behavioral: Voice Therapy and Heart Rate Variability BiofeedbackVoice 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. |
| Heart Rate Variability Biofeedback | Active comparator | Behavioral: Heart Rate Variability BiofeedbackHRVB 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 8+ weeks of cough, Fluent English speaker, Have access to an electronic mobile device
Key exclusion criteria (2 listed)
- 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+.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice TherapySee Arm 1 \& 2 | Behavioural | Voice Therapy |
| Voice Therapy and Heart Rate Variability BiofeedbackSee Arm 2 \& 3 | Behavioural | Voice Therapy and Heart Rate Variability Biofeedback |
| Heart Rate Variability BiofeedbackSee Arm 2 \& 3 | Behavioural | Heart Rate Variability Biofeedback |
Primary outcome
Percentage of Cough reduction
Time frame: 3 weeks
Measured by changes in cough severity index and patient recordings
3 secondary outcomes
Durability of cough remediation
Time frame: 8 weeks
Changes in dyspnea
Time frame: 3 weeks
Change in voice
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice Therapy, Voice Therapy and Heart Rate Variability Biofeedback and Heart Rate Variability Biofeedback in people with Cough, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Weissbrod, MD (858-657-8590, pweissbrod@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Cough reduction (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.