MisophoniaEarly Phase 1Miso PropNCT05928689
Behavioral and Pharmacological Reconsolidation Interference in Misophonia
A Early Phase 1 study testing Propranolol Hydrochloride tablet, Reminder and Counterconditioning in people with Misophonia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
One of the core processes presumably underlying misophonia - a condition characterized by decreased tolerance for specific sounds - is associative learning. Using behavioral, computational, and neural analyses of emotional learning and memory processes to understand the unknown behavioral and neural mechanisms… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Misophonia
- What is being tested?
- Propranolol Hydrochloride tablet, Reminder and Counterconditioning
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2023to 30 Sep 2024
- Phase
- Early Phase 1
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hypersensitive to presence of a specific sound, which may be accompanied by irritation, anger/outbursts, or fear.
- Must be between the ages of 18 - 55.
- Must be fluent in English since the study's instructions, surveys, and tasks will be in English
Who cannot join
- Disability or medical condition that prohibits completion of study. Participants must be able to complete all study procedures to ensure optimal conditions for data analysis.
- CNS disease, such as history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological disease, history of head trauma (defined as loss of consciousness>3 min), or history of seizures without a resolved etiology. CNS disease and drugs that act in the peripheral or central nervous system are likely to have effects on patterns of neural activity. We wish to minimize confounding variables.
- Recently used drugs of abuse.
- Pregnancy. The risks associated with neither propranolol exposure during gestation have been studied extensively. We wish to safeguard the health of potential participants and their children.
- Lactation. Propranolol is excreted in human breast-milk, and its impact on infant development has not been studied. We wish to safeguard the health of potential participants and their children.
- Regular use of medication metabolized in the CYP2D6, 1A2, or 2C19 pathways. Drugs that are metabolized in the same pathway as propranolol may increase its efficacy or toxicity. We wish to safeguard the health of participants.
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- Blood pressure over 150/100 or under 100/60 (applicable for either systolic or diastolic measures) and any hypertension requiring medication. Propranolol is known to pose additional risk to individuals with a number of medical conditions. We wish to safeguard the health of our participants.
- Pulse over 100 or under 55.
- History of cardiovascular illness such as cardiac arrhythmia, coronary heart disease or any cardiac dysfunction that requires medication.
- Active respiratory illness including bronchospastic pulmonary disease and chronic obstructive pulmonary disease
- Diabetes mellitus.
- Other medical conditions that make it unsafe to take propranolol (e. g. allergy to propranolol).
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Misophonia-Related Memory Modification Using Reconsolidation Mechanisms: Pharmacological and Behavioral Manipulation
One of the core processes presumably underlying misophonia - a condition characterized by decreased tolerance for specific sounds - is associative learning. Using behavioral, computational, and neural analyses of emotional learning and memory processes to understand the unknown behavioral and neural mechanisms underlying misophonia's associative learning and memory, the study team will evaluate whether interference with the reconsolidation of a reactivated misophonia memory with propranolol can alleviate aversive reaction to misophonia-related cues.
- Conditions
- Misophonia
- Being tested
- Propranolol Hydrochloride tablet, Reminder, Counterconditioning, Placebo
- Medical subject headings
- misophonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol Hydrochloride tabletDrug
Single dose of 40 mg propranolol tablet
ReminderBehavioural
Reactivation of misophonia trigger memory
CounterconditioningBehavioural
Counterconditioning will consist of presentation of misophonia cues paired with monetary rewards.
PlaceboDrug
Matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Memory Reminder followed by Propranolol Hydrochloride | Experimental | This arm aims to have 30 participants with a pharmacological manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger followed by ingestion of a propranolol hydrochloride tablet. Receives: Drug: Propranolol Hydrochloride tablet; Behavioral: Reminder |
| Memory reminder followed by Placebo | Placebo comparator | This arm aims to have 30 participants with a pharmacological manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger followed by ingestion of a placebo tablet. Receives: Behavioral: Reminder; Drug: Placebo |
| No memory reminder followed by Propranolol Hydrochloride | Experimental | This arm aims to have 30 participants with a pharmacological manipulation. They will not receive a reminder to reactivate their memory of a misophonia sound and only receive a propranolol hydrochloride tablet. Receives: Drug: Propranolol Hydrochloride tablet |
| Memory reminder followed by counterconditioning | Experimental | This arm aims to have 30 participants with a behavioral manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger and then will undergo counterconditioning. Receives: Behavioral: Reminder; Behavioral: Counterconditioning |
| No memory reminder followed by counterconditioning | Experimental | This arm aims to have 30 participants with a behavioral manipulation. They will not receive a reminder to reactivate their memory of a misophonia trigger and then undergo counterconditioning. Receives: Behavioral: Counterconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average Galvanic skin response based on deflections of a wave
Using galvanic skin response based on deflections of a wave, a difference between the average response to the misophonia-related video before and after the pharmacological or behavioral manipulation will be measured. The difference in scores across conditions will be compared. A greater deflection indicates greater sympathetic nervous system arousal.
Measured: Baseline and after 6 hours
Change in average heart rate
Using heart rate measurement, a difference between the average response to the misophonia-related video before and after the pharmacological or behavioral manipulation will be measured. The difference in scores across conditions will be compared. Reduced heart rate will indicate manipulation efficacy
Measured: Baseline and after 6 hours
Change in Approach-Avoidance test
Using an approach-avoidance test, the difference between the monetary amounts earned before and after the pharmacological or behavioral manipulation will be measured. The minimum monetary amount earned is $0 and the maximum monetary amount earned is $23. A higher monetary amount earned indicates greater approach towards an avoidant cue. The difference in monetary amounts across conditions will be compared.
Measured: Baseline and after 6 hours
Secondary outcomes (9)
Change in Approach-Avoidance test
Using an approach-avoidance test, the difference between the monetary amounts earned before and after the pharmacological or behavioral manipulation will be measured. The minimum monetary amount earned is $0 and the maximum monetary amount earned is $23. A higher monetary amount earned indicates greater approach towards an avoidant cue. The difference in monetary amounts across conditions will be compared.
Measured: about 1 week later
Change in Approach-Avoidance test
Using an approach-avoidance test, the difference between the monetary amounts earned before and after the pharmacological or behavioral manipulation will be measured. The minimum monetary amount earned is $0 and the maximum monetary amount earned is $23. A higher monetary amount earned indicates greater approach towards an avoidant cue. The difference in monetary amounts across conditions will be compared.
Measured: Baseline and 1 month later
Change in decision making task
Using a decision making task based on choice behavior (choosing the correct machine more often), the study team will fit computational models to understand reactivity to misophonia-related cues across conditions.
The study team will measure a difference in the task responses after the pharmacological or behavioral manipulation. Measures will include learning rate, and a link between prediction error and self-reported mood. The scores across conditions will be compared.
Measured: Baseline and after 6 hours
Change in decision making task
Using a decision making task based on choice behavior (choosing the correct machine more often), the study team will fit computational models to understand reactivity to misophonia-related cues across conditions.
The study team will measure a difference in the task responses after the pharmacological or behavioral manipulation. Measures will include learning rate, and a link between prediction error and self-reported mood. The scores across conditions will be compared.
Measured: Baseline and about 1 week
Change in decision making task
Using a decision making task based on choice behavior (choosing the correct machine more often), the study team will fit computational models to understand reactivity to misophonia-related cues across conditions.
The study team will measure a difference in the task responses after the pharmacological or behavioral manipulation. Measures will include learning rate, and a link between prediction error and self-reported mood. The scores across conditions will be compared.
Measured: Baseline and 1 month later
Change in Average Galvanic skin response based on deflections of a wave
Using galvanic skin response based on deflections of a wave, a difference between the average response to the misophonia-related video before and after the pharmacological or behavioral manipulation will be measured. The difference in scores across conditions will be compared. A greater deflection indicates greater sympathetic nervous system arousal.
Measured: about 1 week later
Change in Average Galvanic skin response based on deflections of a wave
Using galvanic skin response based on deflections of a wave, a difference between the average response to the misophonia-related video before and after the pharmacological or behavioral manipulation will be measured. The difference in scores across conditions will be compared. A greater deflection indicates greater sympathetic nervous system arousal.
Measured: about 1 month later
Change in average heart rate
Using heart rate measurement, a difference between the average response to the misophonia-related video before and after the pharmacological or behavioral manipulation will be measured. The difference in scores across conditions will be compared. Reduced heart rate will indicate manipulation efficacy
Measured: about 1 week later
Change in average heart rate
Using heart rate measurement, a difference between the average response to the misophonia-related video before and after the pharmacological or behavioral manipulation will be measured. The difference in scores across conditions will be compared. Reduced heart rate will indicate manipulation efficacy
Measured: about 1 month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start2 Jun 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MisophoniaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study team will measure reactivity to misophonia-related cues following either a pharmacological manipulation via a 40 mg propranolol tablet or behavioral manipulation via counterconditioning. The study team predicts that participants with misophonia who experience a reminder (reactive a misophonia memory) and receive the pharmacological or behavioral manipulation, will show reduced reactivity to misophonia cues. Other groups that undergo one of these components alone (reminder only, drug only, counterconditioning only) will continue to show heightened reactivity to misophonia cues.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Schiller, Icahn School of Medicine at Mount Sinai
- Investigators
- Daniela Schiller, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiJames Murrough, MD, PhD, Principal investigator, Icahn School of Medicine at Mount SinaiLaili Soleimani, MD, Msc, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928689
- Sponsor's protocol ID
- STUDY-22-01280
- Acronym
- Miso Prop
- Status last verified
- Oct 2024
- First submitted
- 21 Jun 2023
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will publicly share analyzed statistical summaries which are sufficient for data assessment, reanalysis, and meta-analysis, and reproduction of figures.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misophonia-Related Memory Modification Using Reconsolidation Mechanisms: Pharmacological and Behavioral Manipulation
- ClinicalTrials.gov ID
- NCT05928689
- Acronym / sponsor ID
- Miso Prop / STUDY-22-01280
- Conditions
- Misophonia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 3 Jul 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.
One of the core processes presumably underlying misophonia - a condition characterized by decreased tolerance for specific sounds - is associative learning. Using behavioral, computational, and neural analyses of emotional learning and memory processes to understand the unknown behavioral and neural mechanisms underlying misophonia's associative learning and memory, the study team will evaluate whether interference with the reconsolidation of a reactivated misophonia memory with propranolol can alleviate aversive reaction to misophonia-related cues.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
- Model description
- The study team will measure reactivity to misophonia-related cues following either a pharmacological manipulation via a 40 mg propranolol tablet or behavioral manipulation via counterconditioning. The study team predicts that participants with misophonia who experience a reminder (reactive a misophonia memory) and receive the pharmacological or behavioral manipulation, will show reduced reactivity to misophonia cues. Other groups that undergo one of these components alone (reminder only, drug only, counterconditioning only) will continue to show heightened reactivity to misophonia cues.
| Arm | Type | Receives |
|---|---|---|
| Memory Reminder followed by Propranolol Hydrochloride | Experimental | Drug: Propranolol Hydrochloride tablet, Behavioral: ReminderThis arm aims to have 30 participants with a pharmacological manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger followed by ingestion of a propranolol hydrochloride tablet. |
| Memory reminder followed by Placebo | Placebo comparator | Behavioral: Reminder, Drug: PlaceboThis arm aims to have 30 participants with a pharmacological manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger followed by ingestion of a placebo tablet. |
| No memory reminder followed by Propranolol Hydrochloride | Experimental | Drug: Propranolol Hydrochloride tabletThis arm aims to have 30 participants with a pharmacological manipulation. They will not receive a reminder to reactivate their memory of a misophonia sound and only receive a propranolol hydrochloride tablet. |
| Memory reminder followed by counterconditioning | Experimental | Behavioral: Reminder, Behavioral: CounterconditioningThis arm aims to have 30 participants with a behavioral manipulation. They will receive a reminder to reactivate their memory of a misophonia trigger and then will undergo counterconditioning. |
| No memory reminder followed by counterconditioning | Experimental | Behavioral: CounterconditioningThis arm aims to have 30 participants with a behavioral manipulation. They will not receive a reminder to reactivate their memory of a misophonia trigger and then undergo counterconditioning. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Hypersensitive to presence of a specific sound, which may be accompanied by irritation, anger/outbursts, or fear.
- Must be between the ages of 18 - 55.
- Must be fluent in English since the study's instructions, surveys, and tasks will be in English
Key exclusion criteria (12 listed)
- Disability or medical condition that prohibits completion of study. Participants must be able to complete all study procedures to ensure optimal conditions for data analysis.
- CNS disease, such as history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological disease, history of head trauma (defined as loss of consciousness>3 min), or history of seizures without a resolved etiology. CNS disease and drugs that act in the peripheral or central nervous system are likely to have effects on patterns of neural activity. We wish to minimize confounding variables.
- Recently used drugs of abuse.
- Pregnancy. The risks associated with neither propranolol exposure during gestation have been studied extensively. We wish to safeguard the health of potential participants and their children.
- Lactation. Propranolol is excreted in human breast-milk, and its impact on infant development has not been studied. We wish to safeguard the health of potential participants and their children.
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 |
|---|---|---|
| Propranolol Hydrochloride tabletSingle dose of 40 mg propranolol tablet | Drug | Memory Reminder followed by Propranolol Hydrochloride, No memory reminder followed by Propranolol Hydrochloride |
| ReminderReactivation of misophonia trigger memory | Behavioural | Memory Reminder followed by Propranolol Hydrochloride, Memory reminder followed by Placebo, Memory reminder followed by counterconditioning |
| CounterconditioningCounterconditioning will consist of presentation of misophonia cues paired with monetary rewards. | Behavioural | Memory reminder followed by counterconditioning, No memory reminder followed by counterconditioning |
| PlaceboMatching placebo tablet | Drug | Memory reminder followed by Placebo |
Primary outcome
Change in average Galvanic skin response based on deflections of a wave
Time frame: Baseline and after 6 hours
Using galvanic skin response based on deflections of a wave, a difference between the average response to the misophonia-related video before and after the pharmacological or behavioral manipulation will be measured. The difference in scores across conditions will be compared. A greater deflection indicates greater sympathetic nervous system arousal.
Change in average heart rate
Time frame: Baseline and after 6 hours
Using heart rate measurement, a difference between the average response to the misophonia-related video before and after the pharmacological or behavioral manipulation will be measured. The difference in scores across conditions will be compared. Reduced heart rate will indicate manipulation efficacy
Change in Approach-Avoidance test
Time frame: Baseline and after 6 hours
Using an approach-avoidance test, the difference between the monetary amounts earned before and after the pharmacological or behavioral manipulation will be measured. The minimum monetary amount earned is $0 and the maximum monetary amount earned is $23. A higher monetary amount earned indicates greater approach towards an avoidant cue. The difference in monetary amounts across conditions will be compared.
9 secondary outcomes
Change in Approach-Avoidance test
Time frame: about 1 week later
Change in Approach-Avoidance test
Time frame: Baseline and 1 month later
Change in decision making task
Time frame: Baseline and after 6 hours
Change in decision making task
Time frame: Baseline and about 1 week
Change in decision making task
Time frame: Baseline and 1 month later
Change in Average Galvanic skin response based on deflections of a wave
Time frame: about 1 week later
Change in Average Galvanic skin response based on deflections of a wave
Time frame: about 1 month later
Change in average heart rate
Time frame: about 1 week later
Change in average heart rate
Time frame: about 1 month later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: Yes. The study team will publicly share analyzed statistical summaries which are sufficient for data assessment, reanalysis, and meta-analysis, and reproduction of figures.
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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.
Daniela Schiller, PhD principal investigator
Icahn School of Medicine at Mount Sinai
James Murrough, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
Laili Soleimani, MD, Msc principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Propranolol Hydrochloride tablet, Reminder and Counterconditioning in people with Misophonia, run by Icahn School of Medicine at Mount Sinai 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 12 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: finished, as of the sponsor's last update on 16 Oct 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 average Galvanic skin response based on deflections of a wave (time frame: Baseline and after 6 hours). The study lists 3 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 16 Oct 2024.