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Ari J Green, Jeffrey M Gelfand, Bruce A Cree...
https://pubmed.ncbi.nlm.nih.gov/29029896Actively Recruiting
Phase 1
Phase 2
Age: 45Years - 65Years
All Genders
ID07304024
A Double-Blinded, Placebo-Controlled, Randomized Phase 1/2a Study of Clemastine Fumarate Plus Engineered Sound to Treat Age-Related Central Auditory Processing Disorder
Led by University of Colorado, Denver · Updated on 2026-04-30
344
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of Clemastine Fumarate combined with engineered sound to treat age-related central auditory processing disorder (CAPD), a condition affecting many people over 40 and causing difficulty hearing in noisy environments. This trial aims to test if the therapy, called Localized Oligodendrocyte Optimization Therapy (LOOT), which showed promise in animal studies, can improve hearing in noise for humans. The study is designed to compare the effectiveness of the drug with or without engineered sound in a controlled, randomized setting. Participants will be randomly assigned to one of four groups: Clemastine Fumarate with engineered sound, Clemastine Fumarate with placebo sound (white or pink noise), placebo drug with engineered sound, or placebo drug with placebo sound. The drug dosage is carefully controlled and given orally over 30 days, while participants listen to the assigned sound stimulation through headphones for one hour daily. The trial includes an adaptive design allowing adjustment of study arms based on interim results. Throughout the study, participants will undergo hearing tests to measure their ability to hear in noisy environments, both before and after treatment. Additional assessments include questionnaires on speech and tinnitus, auditory brainstem response tests, physical exams, blood tests, and EKGs to monitor health and safety. The treatment period lasts one month, with evaluations scheduled around weeks five or six. Safety and hearing improvements are carefully monitored to assess the therapy's impact.
CONDITIONS
Brief Title
A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound
Who Can Participate
Age: 45Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female between 45 and 65 years old at screening/enrollment
- Ability to provide written informed consent and comply with study requirements
- Mild or less high-frequency hearing loss with normal middle-ear function confirmed by audiologist
- Bilateral hearing thresholds below 20 dB HL from 250 Hz to 4000 Hz, no air-bone gaps over 10 dB
- Symmetrical hearing thresholds between ears through 8000 Hz
- Normal Type A tympanograms bilaterally
- No cognitive deficit on Montreal Cognitive Assessment (MOCA)
- Distortion product otoacoustic emission showing no more than 20 dB hearing loss from 250 Hz to 4000 Hz
- Failed hearing in noise test at 15 degrees, defined as signal-to-noise ratio 12 dB below normal
You will not qualify if you...
- Any condition not meeting the inclusion criteria
- Known allergy to clemastine fumarate or similar antihistamines
- Pregnancy or nursing, confirmed by urine pregnancy test
- Lower respiratory diseases like asthma, emphysema, or chronic bronchitis
- Glaucoma or increased eye pressure
- Stenosing peptic ulcers or pyloroduodenal obstruction
- Trouble urinating due to enlarged prostate (except mild cases with warning)
- Significant cardiovascular disease, uncontrolled blood pressure
- Hyperthyroidism
- Alcoholism defined by consumption or diagnosis
- History of seizures
- Suicidal ideation or behavior assessed by Columbia Suicide Severity Rating Scale
- Significant or uncontrolled medical disorders including hepatic, hematologic, renal, gastrointestinal, neurological, psychiatric conditions
- Abnormal blood counts or metabolic panels outside specified ranges
- Use of monoamine oxidase inhibitors or CNS depressants
- History of significant ear disorders like repeated infections or Meniere's disease
- History of significant neurological disorders or neurodegenerative diseases
- History of traumatic brain or closed head injury
- Non-native English speakers
- Any other condition that may compromise safety or data quality as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 30 days
Participants receive daily oral medication and listen to sound via headphones for 60 minutes each day during the treatment period.
Daily intervention with medication and sound; visit schedule not specified
Follow-up
Duration - Approximately 2 to 3 weeks after treatment
Participants return for assessments after completing the treatment to evaluate hearing and related outcomes.
1 visit (in-person) after treatment completion
Trial Site Locations
Total: 1 location
1
University of Colorado Anschutz Medical Center
Aurora, Colorado, United States, 80045
Actively Recruiting
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Research Team
A
Ajay Keerthy, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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