Characterize hearing changes in Parkinson
- Trial ID
- NCT07083089
- Official Title
- Phenotyping of Audition in Patients With Early Stage of Neurodegenerative Disorders (Alzheimer and Parkinson' Diseases)
- Goal
- Characterize hearing changes in Parkinson
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Cilcare SAS
- Study Type
- INTERVENTIONAL
- Enrollment
- 309 participants
- Conditions
- Mild Cognitive Impairment (MCI) Amnestic, Parkinson Disease (PD), Healthy Participants
- Interventions
- Thorough Hearing assessment
Summary For Families
The goal is to map how peripheral and central hearing change in early Parkinson's and amnestic MCI, so researchers can spot auditory signs that might help with diagnosis or tracking. Participants undergo a comprehensive hearing and auditory processing assessment that measures ear function and how the brain handles sound, to compare patterns between PD, MCI, and healthy older adults. The study is enrolling French‑speaking adults aged 50 to 85, including people with early Parkinson's (diagnosed by 2015 criteria, MoCA ≥23), people with amnestic MCI (MoCA ≥23 or MMSE >24 with specific memory deficits), and cognitively normal controls (MoCA ≥26). People with conductive ear disease, cochlear implants, major psychiatric or neurological disorders, certain ototoxic drug use, type 2 diabetes, or other listed exclusions cannot join.
Locations
- CHU Gui de Chauliac, Montpellier, France
- CHU Nice, Nice, France
- CHU Carémeau, Nîmes, France
- Hospices Civils de Lyon, Hôpital des Charpennes, Villeurbanne, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Thorough Hearing assessment. The goal is to map how peripheral and central hearing change in early Parkinson's and amnestic MCI, so researchers can spot auditory signs that might help with diagnosis or tracking. Participants undergo a comprehensive hearing and auditory processing assessment that measures ear function and how the brain handles sound, to compare patterns between PD, MCI, and healthy older adults. The study is enrolling French‑speaking adults aged 50 to 85, including people with early Parkinson's (diagnosed by 2015 criteria, MoCA ≥23), people with amnestic MCI (MoCA ≥23 or MMSE >24 with specific memory deficits), and cognitively normal controls (MoCA ≥26). People with conductive ear disease, cochlear implants, major psychiatric or neurological disorders, certain ototoxic drug use, type 2 diabetes, or other listed exclusions cannot join.
- Who can participate?
- Participants must be between 50 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 4 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 8 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.