Shortness of Breath/DyspneaNCT05973513
Open Trial of Biofeedback for Respiratory Symptoms
An observational study of Shortness of Breath/Dyspnea, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Biofeedback is a therapeutic paradigm that teaches patients how to gain awareness and control over previously unrecognized sympathetic changes such as body temperature, blood pressure, and heart rate. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shortness of Breath/Dyspnea
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: (1) participants must be between 18-60; (2) English speaking; (3) must have least one respiratory sx and have received care from a pulmonologist for this sx
Who may be able to join
- participants must be between 18-60
- English speaking
- must have least one respiratory sx and have received care from a pulmonologist for this sx
Who cannot join
- severe psychopathology (e.g., psychosis, active suicidality, moderate to severe intellectual impairment).
Trial locations and contacts
1 site in 1 country.
About this study
Biofeedback is a therapeutic paradigm that teaches patients how to gain awareness and control over previously unrecognized sympathetic changes such as body temperature, blood pressure, and heart rate. We propose to use a six session biofeedback protocol that includes heart-rate variability (HRV) biofeedback, respiration/relaxation training, and body temperature control to treat patients with unaddressed respiratory symptoms (e.g. shortness of breath) who are under the care of pulmonologists and have not responded to traditional biomedical approaches (e.g. inhalers, pulmonary rehab, etc.).
Read the detailed description
Biofeedback is a therapeutic paradigm that teaches patients how to gain awareness and control over previously unrecognized sympathetic changes such as body temperature, blood pressure, and heart rate. Through a series of mind-body techniques, patients are taught to reduce sympathetic responses, leading to self-regulation over physiological responses that affect somatic sensitivity. The investigators propose to use a six session biofeedback protocol that includes heart-rate variability (HRV) biofeedback, respiration/relaxation training, and body temperature control to treat patients with unaddressed respiratory symptoms (e.g. shortness of breath) who are under the care of pulmonologists and have not responded to traditional biomedical approaches (e.g. inhalers, pulmonary rehab, etc.). The aim of the study is to determine whether patients who complete a six-session biofeedback protocol report a decrease in somatic symptoms, and improvements in self-rated mental health (depression, anxiety, quality of life) after the program and at three-months follow-up. The investigators will also study whether these improvements are also related to reduced healthcare utilization.
The investigators plan to recruit up to 100 participants in the study. Participants who are screened as eligible for biofeedback for their physical ailments or psychological complaints will be asked complete a set of questionnaires before, after, and three months' post-treatment to evaluate the utility of the biofeedback treatment protocol. These questionnaires will be available online and will be completed from home. Participants who are eligible to participate but cannot complete questionnaires from home will be given the option of completing the questionnaires in the office before the first biofeedback session. Participants that cannot be immediately enrolled in the protocol due to scheduling reasons will be asked to complete the questionnaires at recruitment to serve as wait-list controls. They will complete the same consent as other participants. The investigators anticipate that questionnaires will take 30 minutes to complete, totaling about 90 minutes for participants immediately enrolled and 120 minutes for wait-list controls.
Each biofeedback session will take 1 hour each. Session 1 of biofeedback will present the rationale and evidence for the treatment, teach breathing techniques, and introduce the biofeedback sensors for respiration, heart rate and temperature using the Biotrace software. The session will focus on breathing rate practice. Session 2 will introduce heart rate variability (HRV), cover breathing rhythm, and focus on the completion Resonance Frequency Assessment, an exercise to identify a participant's ideal breath rate for sustaining HRV. Session 3 will continue HRV practice using a separate software with video games, Alive. Session 4 will repeat session 3 but with more challenging practice of HRV video games. Session 5 will continue HRV practice in the first software (Biotrace) then will introduce participants to temperature control. Session 6 will repeat Session 5 but with more challenging practice for temperature control. Total time for participation will be approximately seven hours across three to six months.
- Conditions
- Shortness of Breath/Dyspnea
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Enrollment | We propose to study whether patients who complete a clinical six-session biofeedback protocol will demonstrate improvements in mental and physical health. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on the PHQ-9
Improvement in self-rated depressive sx on the PHQ-9
Measured: After six week protocol and 3 months after six week protcol
Change in score on the GAD-7
Improvement in self-rated anxiety sx on the GAD-7
Measured: After six week protocol and 3 months after six week protcol
Change in score on the SF-36
Improvement in self-rated QOL on the SF-36
Measured: After six week protocol and 3 months after six week protcol
Change in score on the PHQ-15
Improvement in self-rated physical symptoms on the PHQ-15
Measured: After six week protocol and 3 months after six week protcol
Change in score on the PSQI
Improvement in self-rated sleep quality and duration on the PSQI
Measured: After six week protocol and 3 months after six week protcol
Change in score on the St George's Respiratory Questionnaire (SGRQ)
Improvement in self-rated respiratory sx on the SGRQ
Measured: After six week protocol and 3 months after six week protcol
Secondary outcomes (1)
Change in healthcare utilization
Reduced healthcare utilization: Fewer medical visits and use of prescription and OTC meds in last month
Measured: After six week protocol and 3 months after six week protcol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start1 Aug 2021
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shortness of Breath/DyspneaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natacha D. Emerson, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973513
- Sponsor's protocol ID
- 21-000741-B
- Status last verified
- Dec 2025
- First submitted
- 17 Jul 2023
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Trial of Biofeedback for Respiratory Symptoms
- ClinicalTrials.gov ID
- NCT05973513
- Acronym / sponsor ID
- 21-000741-B
- Conditions
- Shortness of Breath/Dyspnea
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 3 Aug 2023 (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.
Biofeedback is a therapeutic paradigm that teaches patients how to gain awareness and control over previously unrecognized sympathetic changes such as body temperature, blood pressure, and heart rate. We propose to use a six session biofeedback protocol that includes heart-rate variability (HRV) biofeedback, respiration/relaxation training, and body temperature control to treat patients with unaddressed respiratory symptoms (e.g. shortness of breath) who are under the care of pulmonologists and have not responded to traditional biomedical approaches (e.g. inhalers, pulmonary rehab, etc.).
Detailed description
Biofeedback is a therapeutic paradigm that teaches patients how to gain awareness and control over previously unrecognized sympathetic changes such as body temperature, blood pressure, and heart rate. Through a series of mind-body techniques, patients are taught to reduce sympathetic responses, leading to self-regulation over physiological responses that affect somatic sensitivity. The investigators propose to use a six session biofeedback protocol that includes heart-rate variability (HRV) biofeedback, respiration/relaxation training, and body temperature control to treat patients with unaddressed respiratory symptoms (e.g. shortness of breath) who are under the care of pulmonologists and have not responded to traditional biomedical approaches (e.g. inhalers, pulmonary rehab, etc.). The aim of the study is to determine whether patients who complete a six-session biofeedback protocol report a decrease in somatic symptoms, and improvements in self-rated mental health (depression, anxiety, quality of life) after the program and at three-months follow-up. The investigators will also study whether these improvements are also related to reduced healthcare utilization.
The investigators plan to recruit up to 100 participants in the study. Participants who are screened as eligible for biofeedback for their physical ailments or psychological complaints will be asked complete a set of questionnaires before, after, and three months' post-treatment to evaluate the utility of the biofeedback treatment protocol. These questionnaires will be available online and will be completed from home. Participants who are eligible to participate but cannot complete questionnaires from home will be given the option of completing the questionnaires in the office before the first biofeedback session. Participants that cannot be immediately enrolled in the protocol due to scheduling reasons will be asked to complete the questionnaires at recruitment to serve as wait-list controls. They will complete the same consent as other participants. The investigators anticipate that questionnaires will take 30 minutes to complete, totaling about 90 minutes for participants immediately enrolled and 120 minutes for wait-list controls.
Each biofeedback session will take 1 hour each. Session 1 of biofeedback will present the rationale and evidence for the treatment, teach breathing techniques, and introduce the biofeedback sensors for respiration, heart rate and temperature using the Biotrace software. The session will focus on breathing rate practice. Session 2 will introduce heart rate variability (HRV), cover breathing rhythm, and focus on the completion Resonance Frequency Assessment, an exercise to identify a participant's ideal breath rate for sustaining HRV. Session 3 will continue HRV practice using a separate software with video games, Alive. Session 4 will repeat session 3 but with more challenging practice of HRV video games. Session 5 will continue HRV practice in the first software (Biotrace) then will introduce participants to temperature control. Session 6 will repeat Session 5 but with more challenging practice for temperature control. Total time for participation will be approximately seven hours across three to six months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immediate Enrollment | – | –We propose to study whether patients who complete a clinical six-session biofeedback protocol will demonstrate improvements in mental and physical health. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- (1) participants must be between 18-60; (2) English speaking; (3) must have least one respiratory sx and have received care from a pulmonologist for this sx
Key inclusion criteria (3 listed)
- participants must be between 18-60
- English speaking
- must have least one respiratory sx and have received care from a pulmonologist for this sx
Key exclusion criteria (1 listed)
- severe psychopathology (e.g., psychosis, active suicidality, moderate to severe intellectual impairment).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in score on the PHQ-9
Time frame: After six week protocol and 3 months after six week protcol
Improvement in self-rated depressive sx on the PHQ-9
Change in score on the GAD-7
Time frame: After six week protocol and 3 months after six week protcol
Improvement in self-rated anxiety sx on the GAD-7
Change in score on the SF-36
Time frame: After six week protocol and 3 months after six week protcol
Improvement in self-rated QOL on the SF-36
Change in score on the PHQ-15
Time frame: After six week protocol and 3 months after six week protcol
Improvement in self-rated physical symptoms on the PHQ-15
Change in score on the PSQI
Time frame: After six week protocol and 3 months after six week protcol
Improvement in self-rated sleep quality and duration on the PSQI
Change in score on the St George's Respiratory Questionnaire (SGRQ)
Time frame: After six week protocol and 3 months after six week protcol
Improvement in self-rated respiratory sx on the SGRQ
1 secondary outcome
Change in healthcare utilization
Time frame: After six week protocol and 3 months after six week protcol
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shortness of Breath/Dyspnea, run by University of California, Los Angeles 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score on the PHQ-9 (time frame: After six week protocol and 3 months after six week protcol). The study lists 6 primary outcomes in all. 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 19 Dec 2025.