Mild Cognitive Impairment (MCI)NCT07402590
Auditory Stimulation During Sleep to Enhance Long-Term Memory in Amnestic MCI
A study testing Auditory Stimulation in people with Mild Cognitive Impairment (MCI) and Amnestic Mild Cognitive Impairment - aMCI, run by Bitbrain at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Amnestic Mild Cognitive Impairment - aMCI, Alzheimer or Mild Cognitive Impairment
- What is being tested?
- Auditory Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteSpain
- Study dates
- 6 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range > 50 years and ≤ 75 years
- Native Spanish speaker
- Normal or corrected-to-normal color vision
- Diagnosis of Alzheimer's disease with an amnestic phenotype at the mild cognitive impairment stage, confirmed according to the current clinical criteria of NIA-AA (2024) and IWG (2024), as well as the clinical protocols of the treating hospital
- Sufficient hearing without the use of a hearing aid (participant with a hearing threshold of 50 dB or higher in the calibration night hearing test will be excluded)
Who cannot join
- Patients with severe and/or complex chronic systemic diseases: Advanced heart disease, Advanced chronic kidney disease, for example, stage 4 or 5, Severe lung disease, such as GOLD stage III-IV COPD, Metastatic or end-stage cancer, Severe hematologic disorders, Active or chronic uncontrolled infectious diseases (e.g., untreated HIV)
- Evidence of strategic infarcts or other findings on neuroimaging that could be the cause of secondary cognitive impairment
- Abuse of alcohol or other psychotropic substances
- Diagnosed for depression or any severe psychiatric disorder in the 5 years prior to the evaluation
- Changes in treatment with benzodiazepines or antidepressants in the 6 months prior to the initial evaluation
- Treatment with neuroleptics
Show all 9Show fewer
- Epilepsy with active treatment (within the last 5 years) or any comorbidity with a neurological disease that may cause cognitive impairment or brain damage
- Illiteracy
- Moderate or severe sleep apnea (without CPAP during the study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Investigation to Validate the Efficacy and Safety of an Auditory Stimulation Treatment During Sleep to Improve Cognitive Abilities Related to Long-Term Memory in Amnestic Mild Cognitive Impairment (aMCI)
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).
Read the detailed description
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.
- Conditions
- Mild Cognitive Impairment (MCI), Amnestic Mild Cognitive Impairment - aMCI, Alzheimer or Mild Cognitive Impairment
- Being tested
- Auditory Stimulation, Placebo stimulation
- Keywords
- MCI, auditory stimulation, amnestic mild cognitive impairment (aMCI), sleep, memory consolidation, alzheimer disease
- 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.
Auditory StimulationProcedure or surgery
Also called Elevvo Audistim
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.
Placebo stimulationProcedure or surgery
All procedures are identical to the Auditory stimulation condition but the tone volume is set to 0.
| Study group | Role | What they receive |
|---|---|---|
| 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"). Receives: Procedure: Auditory Stimulation; Procedure: Placebo stimulation |
| 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"). Receives: Procedure: Auditory Stimulation; Procedure: Placebo stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Secondary outcomes (7)
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.
Measured: 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).
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
- ESS (Difficulties falling asleep) -> 1-no difficulties / 5-very difficult
- DSS (Difficulties staying asleep) -> 1-no difficulties / 5-very difficult
- VZA (Early awakening) -> 1-did not wake up early / 5-woke too early
- ASC (General sleep characteristics) -> 1-bad / 5-good sleep characteristics
- GSD (Total sleep time) -> hours, minutes in decimal system
- SQ (Sleep quality) -> 1-low / 5-high quality
- GES (Feeling of recovery after sleep) -> 1-not recovered / 5-recovered
- PSYA (Psychological balance before sleep) -> 1-imbalanced / 5-balanced
- PSYE (Psychological exhaustion before sleep) -> 1-not exhausted / 5-exhausted
- PSS (Psychosomatic symptoms during sleep) -> 1-none / 5-many
These metrics will be compared between conditions to evaluate the effect of the intervention.
Measured: 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.
Measured: Administered 15 minutes before sleep onset and 15 minutes after waking up on Nights 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start6 May 2025
- Primary completion24 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitbrain
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Miguel Servet, Hospital Clínico Universitario Lozano Blesa, Hospital Universitario Royo Villanova
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402590
- Sponsor's protocol ID
- P-4-AS
- Other IDs
- C.I PI24/517
- Status last verified
- Feb 2026
- First submitted
- 17 Mar 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- 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 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Investigation to Validate the Efficacy and Safety of an Auditory Stimulation Treatment During Sleep to Improve Cognitive Abilities Related to Long-Term Memory in Amnestic Mild Cognitive Impairment (aMCI)
- ClinicalTrials.gov ID
- NCT07402590
- Acronym / sponsor ID
- P-4-AS
- Conditions
- Mild Cognitive Impairment (MCI), Amnestic Mild Cognitive Impairment - aMCI, Alzheimer or Mild Cognitive Impairment
- Keywords
- MCI, auditory stimulation, amnestic mild cognitive impairment (aMCI), sleep, memory consolidation, alzheimer disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- BitbrainIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Miguel Servet, Hospital Clínico Universitario Lozano Blesa, Hospital Universitario Royo Villanova
- Study start
- 6 May 2025 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 11 Feb 2026 (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 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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auditory stimulation first | Other | Procedure: Auditory Stimulation, Procedure: Placebo stimulationThis arm receives auditory stimulation in the first experimental night ("Night 1") and placebo stimulation in the second night ("Night 2"). |
| Placebo stimulation first | Other | Procedure: Auditory Stimulation, Procedure: Placebo stimulationThis arm receives placebo stimulation in the first experimental night ("Night 1") and auditory stimulation in the second night ("Night 2"). |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age range > 50 years and ≤ 75 years
- Native Spanish speaker
- Normal or corrected-to-normal color vision
- Diagnosis of Alzheimer's disease with an amnestic phenotype at the mild cognitive impairment stage, confirmed according to the current clinical criteria of NIA-AA (2024) and IWG (2024), as well as the clinical protocols of the treating hospital
- Sufficient hearing without the use of a hearing aid (participant with a hearing threshold of 50 dB or higher in the calibration night hearing test will be excluded)
Key exclusion criteria (9 listed)
- Patients with severe and/or complex chronic systemic diseases: Advanced heart disease, Advanced chronic kidney disease, for example, stage 4 or 5, Severe lung disease, such as GOLD stage III-IV COPD, Metastatic or end-stage cancer, Severe hematologic disorders, Active or chronic uncontrolled infectious diseases (e.g., untreated HIV)
- Evidence of strategic infarcts or other findings on neuroimaging that could be the cause of secondary cognitive impairment
- Abuse of alcohol or other psychotropic substances
- Diagnosed for depression or any severe psychiatric disorder in the 5 years prior to the evaluation
- Changes in treatment with benzodiazepines or antidepressants in the 6 months prior to the initial evaluation
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 |
|---|---|---|
| Auditory StimulationAlso: Elevvo AudistimBrief 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. | Procedure or surgery | Auditory stimulation first, Placebo stimulation first |
| Placebo stimulationAll procedures are identical to the Auditory stimulation condition but the tone volume is set to 0. | Procedure or surgery | Auditory stimulation first, Placebo stimulation first |
Primary outcome
Performance (pre vs post-sleep) in a word pair association task
Time frame: 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).
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.
Performance (pre vs post-sleep) in a visuospatial memory task
Time frame: 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).
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.
7 secondary outcomes
Working memory performance
Time frame: 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).
Slow wave and sleep spindle activity
Time frame: Throughout Nights 1/2.
Sleep macrostructure - Total Sleep Time
Time frame: Throughout Nights 1/2.
Sleep macrostructure - Percentage of Time per Sleep Stage
Time frame: Throughout Nights 1/2.
Sleep macrostructure - Sleep Efficiency
Time frame: Throughout Nights 1/2.
Subjective sleep quality
Time frame: Administered 0.5-1 hour before and after waking up on Nights 1 and 2.
Subjective sleep quality
Time frame: Administered 15 minutes before sleep onset and 15 minutes after waking up on Nights 1 and 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory Stimulation in people with Mild Cognitive Impairment (MCI) and Amnestic Mild Cognitive Impairment - aMCI, run by Bitbrain at 1 site in Spain.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 11 Feb 2026. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (pre vs post-sleep) in a word pair association task (time frame: 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).). The study lists 2 primary outcomes in all. 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 11 Feb 2026.