Natacha Emerson
Los Angeles, California, 90095, United States
NCT Number: NCT05973513
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.).
This study is active but is not currently recruiting participants.
18 year–60 year
All sexes
Observational
Los Angeles, California, 90095, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
severe psychopathology (e.g., psychosis, active suicidality, moderate to severe intellectual impairment).
Time frame: After six week protocol and 3 months after six week protcol
Improvement in self-rated depressive sx on the PHQ-9
Time frame: After six week protocol and 3 months after six week protcol
Improvement in self-rated anxiety sx on the GAD-7
Time frame: After six week protocol and 3 months after six week protcol
Improvement in self-rated QOL on the SF-36
Time frame: After six week protocol and 3 months after six week protcol
Improvement in self-rated physical symptoms on the PHQ-15
Time frame: After six week protocol and 3 months after six week protcol
Improvement in self-rated sleep quality and duration on the PSQI
Time frame: After six week protocol and 3 months after six week protcol
Improvement in self-rated respiratory sx on the SGRQ
Time frame: After six week protocol and 3 months after six week protcol
Reduced healthcare utilization: Fewer medical visits and use of prescription and OTC meds in last month
University of California, Los Angeles
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07128511
Dyspnea, Pathological Conditions, Signs and Symptoms
Gainesville, Florida, United States
View Trial DetailsNCT07716696
Anxiety Disorders, Cardiovascular Diseases
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT06969573
COPD (Chronic Obstructive Pulmonary Disease), Chronic Disease
Edmonton, Alberta, Canada
View Trial DetailsNCT07681934
Dyspnea, Female Urogenital Diseases and Pregnancy Complications
Konya, Karatay, Turkey (Türkiye)
View Trial Details