Open Trial of Biofeedback for Respiratory Symptoms

NCT05973513 | Active Not Recruiting

• 1 other identifier: 21-000741-B
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.).

Conditions

Shortness of Breath/Dyspnea

Outcome Measures

Primary Outcomes (6)

• Change in score on the PHQ-9

  Improvement in self-rated depressive sx on the PHQ-9

  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

  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

  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

  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

  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

  After six week protocol and 3 months after six week protcol

Secondary Outcomes (1)

• Change in healthcare utilization

  After six week protocol and 3 months after six week protcol

Study Arms (1)

Immediate Enrollment

We propose to study whether patients who complete a clinical six-session biofeedback protocol will demonstrate improvements in mental and physical health.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• participants must be between 18-60
• English speaking
• must have least one respiratory sx and have received care from a pulmonologist for this sx

You may not qualify if:

• severe psychopathology (e.g., psychosis, active suicidality, moderate to severe intellectual impairment).

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Natacha Emerson

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 3, 2023
• Study Start: August 1, 2021
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (1)