Thorough Hearing assessment for Parkinson's (NCT07083089)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 8 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.