NCT07051239Not yet recruiting
Sleep Stimulation to Enhance Waste Clearance in the Brain
Enhancing Waste Clearance Through Sleep Stimulation
Source: ClinicalTrials.gov · Last updated 9 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to examine whether multi-night closed-loop auditory stimulation (CLAS) during sleep can enhance waste clearance and memory consolidation in healthy adults and older adults with subjective cognitive decline or mild cognitive impairment who exhibit elevated brain amyloid levels identified through prior clinical screening. Specifically, the study investigates whether sleep stimulation increases the clearance of plasma biomarkers related to neurodegeneration, improves the brain's waste clearance system, and supports memory consolidation. Participants will undergo five nights each of CLAS and sham (no stimulation) interventions, with a washout period in between. They will also complete clinical assessments, including MRI scans, blood sample collection, and cognitive testing, and will keep track of subjective sleep quality, sleepiness, mood, and fatigue throughout the interventions.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- First submitted
- 26 Jun 2025
- Start date
- Sept 2025
- Primary completion date
- Sept 2028
- Lead sponsor
- Erasme University Hospital
- Diseases
- Alzheimer disease
- NCT number
- NCT07051239
What you commit to
- Study type: Interventional
- Planned participants: 105
- From Sept 2025 to the primary completion date, Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing treatment with psychotropic medications (benzodiazepines, antidepressants).
Other illness
- Current or past psychiatric or neurological conditions (except for those directly associated with the patient group).
- The presence of severe untreated sleep disorders.
Other
- The presence of irregular sleep-wake cycles (due to shiftwork or extreme chronotype).
- The presence of moderate depression or high levels of anxiety.
- 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
Who the study is looking for
- 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.
Criteria the registry did not label
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Universitaire de Bruxelles Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.