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| ID | Type | Description | Link |
|---|---|---|---|
| C.I PI24/517 | Other Identifier | Comité de Ética de la Inv. de la Comunidad Autónoma de Aragón |
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| Name | Class |
|---|---|
| Hospital Miguel Servet | OTHER |
| Hospital ClÃnico Universitario Lozano Blesa | OTHER |
| Hospital Royo Villanova de Zaragoza | UNKNOWN |
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This study aims to evaluate the efficacy and safety of Elevvo AudiStim, a sleep auditory stimulation device, as a symptomatic treatment for patients with amnestic mild cognitive impairment (aMCI).
Amnestic Mild Cognitive Impairment (aMCI) is a precursor of dementia that involves memory impairment as a primary symptom. The condition presents a valuable opportunity for intervention before a potential progression to more severe, life-altering stages. A technique called "auditory stimulation during sleep" has previously been shown to improve memory by triggering neural oscillations such as slow waves and sleep spindles, which are implicated in memory processing. We hypothesize that the technique might improve memory also in patients with aMCI. This investigation is thus designed to systematically assess both the product's efficacy as a symptomatic treatment for patients with amnestic mild cognitive impairment (aMCI) and its overall safety profile.
After an initial calibration night ("Night 0"), two experimental nights will be performed ("Night 1" and "Night 2"), separated by 14 days. 7 days after each experimental night, a daytime long-term follow-up will be performed ("LT1" and "LT2"). Participants will receive either real or sham auditory stimulation during sleep, such that all participants will participate in both these conditions in a randomized balanced order.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auditory stimulation first | Other | This arm receives auditory stimulation in the first experimental night ("Night 1") and placebo stimulation in the second night ("Night 2"). |
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| Placebo stimulation first | Other | This arm receives placebo stimulation in the first experimental night ("Night 1") and auditory stimulation in the second night ("Night 2"). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auditory Stimulation | Procedure | Brief auditory stimuli (50-ms bursts of pink noise) are delivered to patients once they have entered stable non-rapid eye movement (NonREM) sleep. The volume is automatically adjusted to optimize the induction of targeted neural oscillations, specifically slow waves and sleep spindles, while minimizing the risk of arousal. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance (pre vs post-sleep) in a word pair association task | Memory performance in this task is measured as the number of word pairs recalled during morning and long-term recall, subtracted from the number of word pairs indicated during immediate recall. This metric will be compared between the two experimental conditions. | Immediate recall: right before Nights 1/2 (1 hour before going to sleep); Morning recall: right after Nights 1/2 (1 hour after waking up); Long-term recall: during LT 1/2 (7 days after the start day of Nights 1/2). |
| Performance (pre vs post-sleep) in a visuospatial memory task | Memory performance is measured as the number of recognized images and correctly indicated image locations during morning and long-term recall, subtracted from the respective numbers during immediate recall. This metric will be compared between the two experimental conditions. | Immediate recall: right before Nights 1/2 (1 hour before going to sleep); Morning recall: right after Nights 1/2 (1 hour after waking up); Long-term recall: during LT 1/2 (7 days after the start day of Nights 1/2). |
| Measure | Description | Time Frame |
|---|---|---|
| Working memory performance | Working memory performance will be measured by the number of correct responses in the Sternberg task, administered after sleep in both conditions. This metric will be compared between conditions to evaluate the effect of the intervention. | Morning recall: right after Nights 1/2 (1 hour after waking up); Long-term recall: during LT 1/2 (7 days after the start day of Nights 1/2). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bit&Brain Technologies SL | Zaragoza | Zaragoza | 50006 | Spain |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| ID | Term |
|---|---|
| D000161 | Acoustic Stimulation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D010812 | Physical Stimulation |
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| Placebo stimulation | Procedure | All procedures are identical to the Auditory stimulation condition but the tone volume is set to 0. |
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| Slow wave and sleep spindle activity | Neural oscillations will be analyzed using event detection to estimate event rates (incidences per minute) and event amplitudes (uV), as well as spectral analysis to quantify power (uV2/Hz) across relevant frequencies. The results will be evaluated by calculating linear correlations between these metrics (sleep spindle rate, amplitude, power, as well as slow-wave rate, amplitude, and power) and the two primary endpoints. | Throughout Nights 1/2. |
| Sleep macrostructure - Total Sleep Time | Sleep macrostructure will be measured using the scoring manual of the American Academy of Sleep Medicine (AASM; Iber et al., 2007) as the established standard. Obtaining the sleep stage for each 30-sec epoch of the recording, allows the total sleep time (in minutes). This metric will be compared between conditions to evaluate the effect of the intervention. | Throughout Nights 1/2. |
| Sleep macrostructure - Percentage of Time per Sleep Stage | Sleep macrostructure will be measured using the scoring manual of the American Academy of Sleep Medicine (AASM; Iber et al., 2007) as the established standard. Obtaining the sleep stage for each 30-sec epoch of the recording, allows calculating the percentage of time spent in each of the sleep stages: N1, N2, N3, REM, Wake (%). This metric will be compared between conditions to evaluate the effect of the intervention. | Throughout Nights 1/2. |
| Sleep macrostructure - Sleep Efficiency | Sleep macrostructure will be measured using the scoring manual of the American Academy of Sleep Medicine (AASM; Iber et al., 2007) as the established standard. Obtaining the sleep stage for each 30-sec epoch of the recording, allows calculating the sleep efficiency (%), which represents the percentage of the night that is spent in actual sleep. This metric will be compared between conditions to evaluate the effect of the intervention. | Throughout Nights 1/2. |
| Subjective sleep quality | Subjective sleep quality will be measured using the SF-A-R questionnaire (German: "Schlaffragebogen A Revidierte Fassung"). This questionnaire measures 10 indices about sleep characteristics:
These metrics will be compared between conditions to evaluate the effect of the intervention. | Administered 0.5-1 hour before and after waking up on Nights 1 and 2. |
| Subjective sleep quality | Sleepiness will be measured using the Stanford Sleepiness Scale. This test measures sleepiness in a range from 1 (wide awake) to 8 (fast asleep). This metric will be compared between conditions to evaluate the effect of the intervention. | Administered 15 minutes before sleep onset and 15 minutes after waking up on Nights 1 and 2 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D008919 |
| Investigative Techniques |