Home-Based Closed-Loop Auditory Stimulation to Enhance Slow-Wave Activity in MCI Due to Alzheimer… (NCT07672977) | Clinical Trial Compass
By InvitationNot Applicable
Home-Based Closed-Loop Auditory Stimulation to Enhance Slow-Wave Activity in MCI Due to Alzheimer's Disease: A Proof-of-Concept Study
Spain30 participantsStarted 2025-07-01
Plain-language summary
This proof-of-concept study explores whether long-term home-based closed-loop auditory stimulation during sleep enhances slow-wave activity (SWA) and yields preliminary efficacy signals in patients with amnestic mild cognitive impairment due to Alzheimer's disease (MCI-AD), confirmed by cerebrospinal fluid (CSF) biomarkers or positron emission tomography (PET).
The intervention is self-administered at participants' homes over an initial treatment period of 3 months, followed by a 1-month off-treatment (washout) period. Participants may then enter an optional extension phase consisting of 3 additional months of treatment followed by a second 1-month washout period, for a total study duration of up to 8 months.
Participants who complete the Nana-Lab Study (NCT07402590) may be invited to provide informed consent for screening and potential enrollment in this study. All enrolled participants receive nightly active treatment during intervention periods. This study does not include randomization or a sham control group.
Who can participate
Age range
50 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* Age between 50 and 75 years (inclusive).
* Spanish as native language.
* Diagnosis of amnestic mild cognitive impairment due to Alzheimer's disease, confirmed by cerebrospinal fluid biomarkers or amyloid PET.
* Normal or corrected-to-normal color vision (required for completion of visual-analog study assessments).
* Adequate hearing to perceive the auditory stimuli used in the intervention, defined as a hearing threshold of 50 dB or below, assessed during the screening session.
Exclusion criteria:
* Severe systemic or complex chronic disease that, in the investigator's judgment, would compromise participant safety or data quality, including but not limited to: advanced heart disease; advanced chronic kidney disease (stage 4 or 5); severe pulmonary disease (e.g., COPD GOLD stage III-IV); metastatic or terminal cancer; severe hematological disorders; or active or uncontrolled chronic infectious disease (e.g., untreated HIV).
* Evidence on neuroimaging of strategic infarcts or other findings that may account for secondary cognitive impairment.
* Alcohol or psychotropic substance abuse.
* Diagnosis of depression or any severe psychiatric disorder within the 5 years prior to evaluation.
* Changes in benzodiazepine or antidepressant treatment within the 6 months prior to baseline evaluation.
* Current treatment with neuroleptics.
* Epilepsy with active treatment within the last 5 years, or any neurological comorbidity that may cause cognitive impairment or …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Target Engagement: Sustained Increase in Slow-Wave Activity During N2-N3 Sleep
Timeframe: Assessed at each intervention night, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).