Clinical trial for Central Auditory Processing Disorder
Official title A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound
ClinicalTrials.gov ID: NCT07304024
What this study is testing
What is Clemastine Fumarate Combined With Engineered Sound?
an investigational combination product being studied as a potential treatment for central auditory processing disorder. is designed to promote oligodendrocyte activity and myelin repair, while the engineered sound aims to stimulate central auditory pathways.
Also referred to as clemastine fumarate.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if a month of Clemastine Fumarate combined with engineered sound can improve the ability to pick out a sound from background noise in people with age‑related central hearing problems.
- Who it's for
- Adults who have trouble hearing in noisy environments and meet the study’s health and hearing criteria.
- What's involved
- Participants will receive either the drug or a placebo and either the engineered sound or white noise for one hour each day for one month. They will have hearing tests, a physical exam, blood tests, and an EKG before and after the treatment period.
- Time commitment
- The study lasts one month, with visits before the start and after the month of treatment for tests and health monitoring.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 65
You may be able to join if
- Male or female between 45 and 65 years old (middle aged) at the screening/enrollment visit (Visit 1).
- Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.
- bilateral hearing thresholds \ 10 dB.
- symmetrical hearing thresholds between the ears through 8000 Hz, defined as \<20 dB difference at any single audiometric frequency or \< 15 dB...
- normal (Type A) tympanograms bilaterally.
You likely can't join if
- Any people who do not fall under the criteria defined above.
- Known sensitivity to clemastine fumarate or other antihistamines of similar composition
- Pregnancy or nursing mother as determined objectively with a urine pregnancy test
- Lower respiratory tract disease including asthma, or breathing difficulties such as emphysema or chronic bronchitis
- Glaucoma or increased intraocular pressure
- Stenosing peptic ulcers or pyloroduodenal obstruction
See the full eligibility criteria
- Male or female between 45 and 65 years old (middle aged) at the screening/enrollment visit (Visit 1).
- Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.
- bilateral hearing thresholds \ 10 dB.
- symmetrical hearing thresholds between the ears through 8000 Hz, defined as \<20 dB difference at any single audiometric frequency or \< 15 dB difference at 2 or more contiguous frequencies.
- normal (Type A) tympanograms bilaterally.
- No cognitive deficit shown upon screening with the Montreal Cognitive Assessment (MOCA) test (Nasreddine et al. 2005).
- Distortion product otoacoustic emission (DPOAE) showing no more than 20 dB hearing loss at audiometric frequencies from 250 Hz to 4000 Hz.
- people failing the hearing in noise test at 15 degrees. Failing is defined as SNR being 12 dB below from what is found in normal hearing people without central hearing loss.
- Any people who do not fall under the criteria defined above.
- Known sensitivity to clemastine fumarate or other antihistamines of similar composition
- Pregnancy or nursing mother as determined objectively with a urine pregnancy test
- Lower respiratory tract disease including asthma, or breathing difficulties such as emphysema or chronic bronchitis
- Glaucoma or increased intraocular pressure
- Stenosing peptic ulcers or pyloroduodenal obstruction
- Trouble urinating due to an enlarged prostate gland. Mild urinary issues (Stage 1 Benign Prostatic Hyperplasia) will not be considered an automatic exclusion but it must be emphasized to patients with this diagnosis...
- Significant cardiovascular disease, chronic hypertension or hypotension
- Hyperthyroidism
- Alcoholism- as defined by consuming on average 3+ drinks per day for women or 4+ drinks per day for men or previous diagnosis of alcohol use disorder by a clinician as defined by DSM V criteria.
- Patients with a history of seizures will be excluded.
- Patients with evidence of suicidal ideation/behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
- Leukopenia as defined as a CBC white blood cell count \< 4000/ul
- Anemia as defined by a CBC Hemoglobin \<9.0 g/dL or \<10.0 g/dL (Grade 2+ CTCAE)
- Lymphopenia as defined by CBC Absolute lymphocyte count \<1000/µL.
- Neutropenia as defined by CBC ANC \<1500/µL (solid tumors), ANC \<1000/µL (hematologic malignancies).
- Thrombocytopenia as defined by CBC Platelet count \<75000/µL
- Hepatic Impairment based on CMP: Total bilirubin \>1.5× ULN, AST/ALT \>3× ULN (or \>5× ULN if liver metastases), Alkaline phosphatase \>3× ULN.
- Hepatic Impairment based on CMP: Serum creatinine \>2.0 mg/dL (alternative threshold).
- Metabolic abnormalities based on CMP: Albumin \<3.0 g/dL
- Monoamine oxidase inhibitor therapy
- CNS depressants (sedatives, tranquilizers, hypnotics)
- A history of significant otologic disorder such as repetitive ear infections or Meniere's disease
- A history of significant neurologic disorder, or current neurodegenerative diseases such as multiple sclerosis, which could present a confound and impact the electrophysiological outcome measures.
- A history of traumatic brain or closed head injury because this can cause symptoms of central auditory processing problems unrelated to aging and demyelination.
- English as a second language (non-native English speakers), which is known to negatively impact scores on speech recognition testing.
- Presence of any other condition or abnormality that in the opinion of the Investigator or his co-PIs would compromise the safety of the patient or the quality of the data.
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.