Sleep Stimulation to Enhance Waste Clearance in the Brain
Launched by ERASME UNIVERSITY HOSPITAL · Jun 26, 2025
Trial Information
Current as of July 23, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether a special type of sound stimulation during sleep can help the brain clear out waste and improve memory. The researchers are interested in how this might work for healthy adults as well as older adults who notice some memory problems or have mild cognitive impairment, especially if these individuals show signs of a buildup of certain proteins in the brain linked to Alzheimer’s disease. The study will compare nights when participants receive the sound stimulation to nights without it, to see if the stimulation helps the brain’s natural cleaning process and supports better memory.
People who might join this study include healthy adults aged 18 to 80, and adults aged 55 to 80 who have mild memory concerns or mild cognitive impairment, along with evidence of brain changes related to Alzheimer’s. Participants need to speak French well and be able to safely undergo MRI brain scans (meaning no metal implants or devices that could interfere). During the study, participants will spend several nights receiving either the sound stimulation or no stimulation, with a break in between. They’ll also have brain scans, blood tests, memory and thinking tests, and will track their sleep quality, mood, and tiredness. It’s important to note that people with certain sleep disorders, significant mental health issues, or who take certain medications may not be eligible. The study is not yet recruiting, but it offers a chance to explore new ways to support brain health during sleep.
Gender
ALL
Eligibility criteria
- For the positive amyloid load group:
- • -Participants who meet the criteria of subjective cognitive decline or mild cognitive impairment (Clinical Dementia Rating \< 2; Mini-Mental State Examination ≥ 21) and brain amyloid-beta (Aβ) accumulation confirmed by CSF or amyloid-PET, the inclusion age range is 55-80 years.
- For healthy groups:
- • -Inclusion age range is 18-80 years.
- Inclusion criteria:
- • Proficiency in the French language (close to native level) to complete the neuropsychological evaluation and cognitive tests.
- • MRI compatibility: absence of metallic materials in the body (implants, vascular clips, certain types of orthopedic material, etc.), a pacemaker or other types of stimulators, cochlear implants, or any other electronic devices.
- Exclusion criteria:
- • Current or past psychiatric or neurological conditions (except for those directly associated with the patient group).
- • The presence of severe untreated sleep disorders.
- • The presence of irregular sleep-wake cycles (due to shiftwork or extreme chronotype).
- • The presence of moderate depression or high levels of anxiety.
- • Ongoing treatment with psychotropic medications (benzodiazepines, antidepressants).
- • Regular or excessive consumption of alcohol or caffeinated drinks.
- • Consumption of other psychoactive substances known to have an impact on the central nervous system.
- • Insufficient visual or auditory acuity to complete the assessments if uncorrected. Normal hearing is required for sound stimulation to be effective.
- • Claustrophobia that prevents undergoing brain imaging (MRI).
- • Pregnancy or currently breastfeeding
About Erasme University Hospital
Erasme University Hospital, a leading institution in clinical research and patient care, is dedicated to advancing medical knowledge and improving health outcomes through innovative clinical trials. As a prominent academic hospital affiliated with the Université libre de Bruxelles, it combines cutting-edge research with comprehensive clinical services, fostering collaboration among healthcare professionals, researchers, and patients. With a strong emphasis on rigorous scientific methodologies and ethical standards, Erasme University Hospital aims to contribute to the development of new therapies and treatment protocols that address pressing health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brussels, , Belgium
Patients applied
Trial Officials
Mélanie Strauss, MD, PhD
Principal Investigator
Université Libre de Bruxelles
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported