HealthyNCT07051239
Sleep Stimulation to Enhance Waste Clearance in the Brain
A study testing Closed-loop acoustic stimulation in people with Healthy and Subjective Cognitive Decline (SCD), run by Erasme University Hospital at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI)
- What is being tested?
- Closed-loop acoustic stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2025to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rebeca Sifuentes Ortega, PhD contact
Belgium1 site
Hôpital Universitaire de Bruxelles
Brussels
Mélanie Strauss, +32 2 555 55 39, melanie.strauss@hubruxelles.be
About this study
Official title: Enhancing Waste Clearance Through Sleep Stimulation
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.
- Conditions
- Healthy, Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), Alzheimer Disease (AD)
- Being tested
- Closed-loop acoustic stimulation
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop acoustic stimulationOther
At-home sleep will be monitored using an EEG headband. Non-awakening auditory stimuli will be delivered during non-rapid eye movement sleep (NREM), timed to the ascending phase of slow waves, using either active or control (sham) conditions.
| Study group | Role | What they receive |
|---|---|---|
| Healthy young, auditory stimulation, then sham | Experimental | Not described Receives: Other: Closed-loop acoustic stimulation |
| Healthy young, sham, then auditory stimulation | Experimental | Not described Receives: Other: Closed-loop acoustic stimulation |
| Healthy old, auditory stimulation, then sham | Experimental | Not described Receives: Other: Closed-loop acoustic stimulation |
| Healthy old, sham then auditory stimulation | Experimental | Not described Receives: Other: Closed-loop acoustic stimulation |
| Positive amyloid load group, auditory stimulation, then sham | Experimental | Not described Receives: Other: Closed-loop acoustic stimulation |
| Positive amyloid load group, sham, then auditory stimulation | Experimental | Not described Receives: Other: Closed-loop acoustic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma biomarkers
Levels of plasma biomarkers associated with neurodegeneration and brain health will be compared between stimulation and sham interventions.
Measured: Blood samples will be collected the morning after each intervention phase. Interventions are separated by one week.
Secondary outcomes (9)
Glymphatic function
Magnetic resonance imaging (MRI) derived measures will serve as proxies for glymphatic function and will be compared between stimulation and sham interventions.
Measured: MRI scans will be performed the morning after each intervention phase. Interventions are separated by one week.
CLAS evoked responses
EEG responses locked to the acoustic stimulation will be examined (phase, amplitude, power, slow oscillations, spindle coupling) during stimulation and sham night recordings. Associations between APOE phenotype, age, amyloid accumulation, brain structure and function, baseline memory performance, sleep quality and responses to CLAS will be evaluated.
Measured: Each night of sleep during each intervention phase, whether receiving stimulation or sham.
Slow wave activity (SWA)
EEG SWA will be assessed during NREM sleep periods from each intervention (stimulation and sham)
Measured: Each night of sleep during each intervention phase, whether receiving stimulation or sham.
Sleep architecture
As measured with the EEG headband, macro- (e.g., duration, latency, distribution of sleep stages), and micro-architecture (slow waves, sleep spindles, rapid eye movements, arousals) differences between stimulation and sham conditions will be assessed.
Measured: Each night of sleep during each intervention phase, whether receiving stimulation or sham.
Change in memory performance
Performance change in declarative memory tasks (cued-recall and recognition measures) will be evaluated.
Measured: Before and after each intervention period. Interventions are separated by one week.
Encoding capacity
Performance in a continuous mnemonic discrimination task (recognition and mnemonic discrimination measures) will be assessed after both stimulation and sham interventions.
Measured: After each intervention phase. Interventions are separated by one week.
Alertness and sustained attention
Performance (reaction times, lapses) in the psychomotor vigilance task (PVT).
Measured: The PVT task will be assessed before and after each intervention phase. Interventions are separated by one week.
Subjective measures after sleep
As measured with morning questionnaires, subjective sleep quality, fatigue, sleepiness, mood, and affect, will be assessed every morning during each stimulation and sham intervention.
Measured: Each morning throughout the intervention phase.
Resting-state functional connectivity
Changes in resting-state functional connectivity measured with fMRI will be compared between stimulation and sham interventions.
Measured: MRI scans will be performed the morning after each intervention phase. Interventions are separated by one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Amsterdam
- Responsible party
- Sponsor
- Investigators
- Mélanie Strauss, MD, PhD, Principal investigator, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051239
- Sponsor's protocol ID
- HUB2025028
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Waste Clearance Through Sleep Stimulation
- ClinicalTrials.gov ID
- NCT07051239
- Acronym / sponsor ID
- HUB2025028
- Conditions
- Healthy, Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), Alzheimer Disease (AD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- University of Amsterdam
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy young, auditory stimulation, then sham | Experimental | Other: Closed-loop acoustic stimulation |
| Healthy young, sham, then auditory stimulation | Experimental | Other: Closed-loop acoustic stimulation |
| Healthy old, auditory stimulation, then sham | Experimental | Other: Closed-loop acoustic stimulation |
| Healthy old, sham then auditory stimulation | Experimental | Other: Closed-loop acoustic stimulation |
| Positive amyloid load group, auditory stimulation, then sham | Experimental | Other: Closed-loop acoustic stimulation |
| Positive amyloid load group, sham, then auditory stimulation | Experimental | Other: Closed-loop acoustic stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed-loop acoustic stimulationAt-home sleep will be monitored using an EEG headband. Non-awakening auditory stimuli will be delivered during non-rapid eye movement sleep (NREM), timed to the ascending phase of slow waves, using either active or control (sham) conditions. | Other | Healthy old, auditory stimulation, then sham, Healthy old, sham then auditory stimulation, Healthy young, auditory stimulation, then sham, Healthy young, sham, then auditory stimulation, Positive amyloid load group, auditory stimulation, then sham, Positive amyloid load group, sham, then auditory stimulation |
Primary outcome
Plasma biomarkers
Time frame: Blood samples will be collected the morning after each intervention phase. Interventions are separated by one week.
Levels of plasma biomarkers associated with neurodegeneration and brain health will be compared between stimulation and sham interventions.
9 secondary outcomes
Glymphatic function
Time frame: MRI scans will be performed the morning after each intervention phase. Interventions are separated by one week.
CLAS evoked responses
Time frame: Each night of sleep during each intervention phase, whether receiving stimulation or sham.
Slow wave activity (SWA)
Time frame: Each night of sleep during each intervention phase, whether receiving stimulation or sham.
Sleep architecture
Time frame: Each night of sleep during each intervention phase, whether receiving stimulation or sham.
Change in memory performance
Time frame: Before and after each intervention period. Interventions are separated by one week.
Encoding capacity
Time frame: After each intervention phase. Interventions are separated by one week.
Alertness and sustained attention
Time frame: The PVT task will be assessed before and after each intervention phase. Interventions are separated by one week.
Subjective measures after sleep
Time frame: Each morning throughout the intervention phase.
Resting-state functional connectivity
Time frame: MRI scans will be performed the morning after each intervention phase. Interventions are separated by one week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebeca Sifuentes Ortega, PhD contact
Mélanie Strauss, MD, PhD principal investigator
Université Libre de Bruxelles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-loop acoustic stimulation in people with Healthy and Subjective Cognitive Decline (SCD), run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mélanie Strauss, MD, PhD (+32 2 555 55 39, melanie.strauss@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma biomarkers (time frame: Blood samples will be collected the morning after each intervention phase. Interventions are separated by one week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.