- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07271485
Propranolol for Misophonia
December 5, 2025 updated by: Jadon Webb, Bloom Mental Health, LLC
Randomized, Placebo-Controlled Pilot Study of Propranolol for Treating Misophonia
The primary goal of this study is to investigate whether a one-time dose of 20 mg oral propranolol can temporarily reduce the adverse emotional and physical symptoms triggered by misophonia.
The secondary goals of this study are:
- Determine potential predictors of response to propranolol treatment, including demographic factors, baseline symptom severity, psychometric instrument item responses, and physiological characteristics.
- Evaluate the safety and tolerability of propranolol in individuals with misophonia.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Bloom Mental Health Clinic
- Phone Number: 303-801-1776
- Email: office@bloommh.com
Study Locations
-
-
Colorado
-
Littleton, Colorado, United States, 80120
- Recruiting
- Bloom Mental Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18-65.
- Able to complete study visit(s) in Littleton, CO.
- Able to give informed consent.
- Participant reports clinically significant misophonia symptoms, as determined by answers on the standardized "Misophonia Trigger Screening Questions for Participants" form (described separately in the protocol). Specifically, participants must demonstrate relevant misophonia trigger responses that meet pre-specified minimum severity criteria detailed on this form.
- A-MISO-S rating scale severity criterion: Participants must score at least a moderate ("2") or higher on question 2 and question 3 of the Amsterdam Misophonia Scale (A-MISO-S) at screening, since this indicates clinically meaningful misophonia severity for study eligibility.
- Able to communicate misophonic distress in writing and reasonably participate in our outpatient clinical setting, meaning able to tolerate being in this outpatient clinical setting, follow the clinic rules for all patients and guests, and respond in an understandable fashion to questions administered to them.
- Must agree to follow study clinician advice and seek additional care outside of this clinic if advised (e.g., if advised to seek help from emergency services for a potentially serious adverse reaction).
- English fluency
Exclusion Criteria:
- Current use of scheduled propranolol for any condition.
- Any of the known contraindications for taking propranolol:
- cardiogenic shock
- sinus bradycardia (<50 bpm)
- greater than first degree heart block
- BP below 90/60
- asthma / bronchial asthma that requires treatment or medication, and/or has caused clinical concerns within the last 5 years
- Other heart conditions that require ongoing medical treatment
- Participants with any of the following relative contraindications for taking propranolol:
- participants who have active anorexia, purging, or who are underweight (<18.5 BMI)
- Active drug or alcohol use within the last 48 hours prior to study participation, or active drug withdrawals
- A history of untreated diabetes or other endocrine disorders that could be harmed by exposure to propranolol
- history of cardiovascular disease or stroke, or symptomatic blood disorders such as anemia
- history of any other severe physical or neurological conditions that may affect their ability to participate in the study
- Participants with liver or kidney disease that would be affect or be affected by the study drug
- Participants may, depending on the circumstances as decided by the study clinician, be excluded for any of the following conditions that may have adverse reactions to propranolol, including: Raynaud disease or other peripheral vascular disease, Pheochromocytoma, Psoriasis, Thyroid disease (untreated, and affected by propranolol), Unexplained dizziness, Oxygen level below 91%, Respirations below 12 or above 20
- Participants taking any other medications that could interfere with the effects of propranolol, as determined by the study clinician (e.g. other beta blockers, alpha blockers,prazosin, clonidine, guanfacine, diuretics, calcium channel blockers, acute us of anti-anxiety medications; other medications that interfere with the adrenergic system; or medications that have a significant effect on propranolol's pharmacology that would normally affect dosing in clinical practice
- Allergy or sensitivity to propranolol, placebo ingredients, and/or capsule ingredients.
- Pregnant or nursing.
- Any of the following in 30 days prior to enrollment: active psychosis, suicidal/ self-harming / homicidal thoughts, bipolar mania, panic attacks, traumatic dissociation, Post-Traumatic Stress Disorder (PTSD) flashbacks, or psychiatric hospitalization.
- Participant self-reports or clinical interview identifies any misophonia-triggered reactions within the past year that posed a significant risk to health or safety, including suicidal or homicidal ideation, or uncontrolled physical behaviors (e.g., self-injury, aggression toward others, throwing objects, screaming, or fleeing uncontrollably). This criterion is assessed via direct structured questioning during participant screening interviews and review of participant self-reports on standardized screening questionnaires.
- Misophonia trigger symptoms are determined by a medical provider to be better explained by a condition other than Misophonia, such as hyperacusis or phonophobia.
- Inability to hear routine sounds and communication (ie severe hearing impairment), only if it interferes with ability to hear the misophonia triggers on the video.
- Participants who are triggered by the sound of water running or a car alarm (our control videos)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Propranolol Pill
10 participants will take one-time dose of 20 mg propranolol pill
|
A one-time dose of 20 mg propranolol
|
|
Placebo Comparator: Placebo Pill
10 participants will take be given a matching one-time dose of placebo
|
A dose of placebo taken orally
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate
Time Frame: Heart rate is continuously monitored via pulse oximetry during each video presentation. The continuous measurement will start at pre-intervention and end after the intervention.
|
Heart rate was chosen as a primary biometric outcome because it reliably indicates sympathetic nervous system activation commonly observed in acute misophonia reactions.
Given propranolol's established pharmacologic effect as a beta-blocker, the hypothesis is that propranolol will significantly blunt the heart rate increase typically elicited by misophonia triggers compared to placebo.
|
Heart rate is continuously monitored via pulse oximetry during each video presentation. The continuous measurement will start at pre-intervention and end after the intervention.
|
|
Visual Analog Scale (VAS)
Time Frame: The scale will be taken immediately after each video clip intervention. It will measure the participant's reaction to each clip.
|
The Visual Analog Scale (VAS) assesses three core emotional domains (anger, anxiety, disgust) and multiple physical sensations frequently reported during acute misophonia episodes, such as feeling hot/sweaty, heart pounding, muscle tension, trembling/shaking, and shortness of breath.
Each response is rated on a sliding scale accompanied by emojis or graphics that visually represent increasing intensity of the sensations or emotions.
This format leverages established evidence from acute pain and emotional-response research, demonstrating that visual analogue scales effectively capture immediate subjective states.
The VAS is based on a Likert scales ranging from 0-7, 0-5, and 0-8 in some questions.
Higher scores indicates more distress and a worst outcome.
|
The scale will be taken immediately after each video clip intervention. It will measure the participant's reaction to each clip.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Grip Strength
Time Frame: Grip Strength measurement is subsequently performed immediately after each video exposure. This will be taken immediately after each video clip intervention in order to measure the participant's reaction to each clip.
|
An innovative exploratory measure of emotional and physical intensity will also be collected using a Grip Strength Meter.
This measure is specifically designed for this study to provide participants with a physical, embodied way to express their subjective feelings of anger, distress, or tension following trigger exposure.
|
Grip Strength measurement is subsequently performed immediately after each video exposure. This will be taken immediately after each video clip intervention in order to measure the participant's reaction to each clip.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 19, 2025
Primary Completion (Estimated)
December 19, 2026
Study Completion (Estimated)
December 19, 2026
Study Registration Dates
First Submitted
November 20, 2025
First Submitted That Met QC Criteria
December 5, 2025
First Posted (Estimated)
December 9, 2025
Study Record Updates
Last Update Posted (Estimated)
December 9, 2025
Last Update Submitted That Met QC Criteria
December 5, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 824
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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