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The goal of this clinical trial is to determine whether acoustic stimulation during sleep can enhance slow-wave sleep (SWS), improve cognitive function, and reduce AD-related pathology in individuals with mild cognitive impairment (MCI), compared with cognitively healthy participants.
The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real-PLAS | Experimental | Receiving phase-locked acoustic stimulation as an intervention |
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| Sham-PLAS | Sham Comparator | Will have the same montage as real-PLAS, but no stimulation will be produced |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plase-Locked Acoustic Stimulation during slow-wave sleep | Device | Participants will wear a mobile, wearable EEG device during sleep. Sleep will be recorded using EEG, and an algorithm will detect slow oscillations (SOs; >1 Hz). In the real-PLAS arm, acoustic stimulation will be applied in phase with the up-state of these slow oscillations. Specifically, the algorithm will detect each SO and trigger brief pink-noise bursts synchronized with the up-state phase, ensuring phase-locked acoustic stimulation (PLAS) is delivered precisely to enhance slow-wave activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on SWS: SO and sleep spindle density | Two defining features of slow-wave sleep (SWS) are slow oscillations (SO) and sleep spindles. Accordingly, the impact of multi-night PLAS on SWS in the study population will be evaluated by measuring the density of both features (expressed as counts per 30 seconds). Post-intervention measurements, including follow-up assessments, will be compared with the baseline night, during which no stimulation is applied, and with the sham group. | 14 nights |
| Impact on SWS: SO and sleep spindle duration | Two defining features of slow-wave sleep (SWS) are slow oscillations (SO) and sleep spindles. Accordingly, the impact of multi-night PLAS on SWS in the study population will be evaluated by measuring the duration of both features (expressed in seconds). Post-intervention measurements, including follow-up assessments, will be compared with the baseline night, during which no stimulation is applied, and with the sham group. | 14 nights |
| Impact on SWS: SO and sleep spindle peak-to-peak amplitude | Two defining features of slow-wave sleep (SWS) are slow oscillations (SO) and sleep spindles. Accordingly, the impact of multi-night PLAS on SWS in the study population will be evaluated by measuring the peak-to-peak amplitude of both features (expressed in µV).Post-intervention measurements, including follow-up assessments, will be compared with the baseline night, during which no stimulation is applied, and with the sham group. | 14 nights |
| Impact on SWS: SO and sleep spindle peak power frequency | Two defining features of slow-wave sleep (SWS) are slow oscillations (SO) and sleep spindles. Accordingly, the impact of multi-night PLAS on SWS in the study population will be evaluated by measuring the peak power frequency of each feature (expressed in Hz). Post-intervention measurements, including follow-up assessments, will be compared with the baseline night, during which no stimulation is applied, and with the sham group. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on GFAP and NfL | Post-intervention plasma levels of Glial fibrillary acidic protein (GFAP, pg/mL) and neurofilament light (NfL, pg/mL), including follow-up assessments, will be measured in the study population and compared with baseline values as well as with the sham group. | Up to 3 months after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Farida Dakterzada, PhD | Contact | +34-973702413 | farida.dakterzada@udl.cat | |
| Gerard Piñol-Ripoll, MD, PhD | Contact | gerard_437302@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Santa Maria de Lleida | Lleida | Catalonia | 25198 | Spain |
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| Phase-locked acoustic stimulation-Sham condition | Device | Participants will have the same setup as in the real-PLAS arm, wearing a mobile, wearable EEG device during sleep. Sleep will be recorded using EEG, and an algorithm will detect slow oscillations (SOs; >1 Hz). No acoustic stimulation will be applied in the sham-PLAS arm. |
|
| 14 nights |
| Impact on SWS: SO and sleep spindle power | Two defining features of slow-wave sleep (SWS) are slow oscillations (SO) and sleep spindles. Accordingly, the impact of multi-night PLAS on SWS in the study population will be evaluated by measuring the power of both features (expressed in µV2). Post-intervention measurements, including follow-up assessments, will be compared with the baseline night, during which no stimulation is applied, and with the sham group. | 14 nights |
| Impact on declarative memory consolidation: correct performance in the Verbal Paired Associates test | The impact of multi-night PLAS on declarative memory performance in the study population will be assessed using the Verbal Paired Associates (VPA) test. Performance will be quantified as the number of correctly recalled word pairs. Post-intervention measurements, including follow-up assessments, will be compared with the first recall, conducted in the morning after the baseline night, and with the sham group. | Up to 3 months after intervention |
| Impact on procedural memory consolidation: correct performance in the Motor Sequence Typing task | The impact of multi-night PLAS on procedural memory performance in the study population will be assessed using the Motor Sequence Typing task (MST). Performance will be quantified as the number of correctly executed sequences (i.e., keypresses) per trial. Post-intervention measurements, including follow-up assessments, will be compared with the first recall, conducted in the morning after the baseline night, and with the sham group. | Up to 3 months after intervention |
| Impact on procedural memory consolidation: incorrect performance in the Motor Sequence Typing task | The impact of multi-night PLAS on procedural memory performance in the study population will be assessed using the Motor Sequence Typing task (MST). Performance will be quantified as the number of incorrectly executed sequences (i.e., keypresses) per trial. Post-intervention measurements, including follow-up assessments, will be compared with the first recall, conducted in the morning after the baseline night, and with the sham group. | Up to 3 months after intervention |
| Impact on procedural memory consolidation: total attempt performance in the Motor Sequence Typing task | The impact of multi-night PLAS on procedural memory performance in the study population will be assessed using the Motor Sequence Typing Task (MST). Performance will be quantified as the total number of executed sequences (i.e., keypresses) per trial. Post-intervention measurements, including follow-up assessments, will be compared with the first recall, conducted in the morning after the baseline night, and with the sham group. | Up to 3 months after intervention |
| Impact on p-tau217 | Post-intervention plasma levels of p-tau217(pg/mL), including follow-up assessments, will be measured in the study population and compared with baseline values as well as with the sham group. | Up to 3 months after intervention |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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