Preventing Cognitive Decline Using Portable, Non-invasive Sleep Enhancement
New trial tests sound stimulation to improve sleep and memory in older adults
Plain English Summary
Effects of Real vs. Soundless Acoustic Stimulation During Deep Sleep on Brain Activity, Memory, and Blood Biomarkers in Older Adults (60-85) With Mild Memory Impairment is a Not Applicable clinical trial sponsored by University of Bern studying Cognitive Decline, Alzheimer Disease, Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), Cognitive Impairment, Mild. This trial tests if special sounds played during deep sleep can improve memory and slow down memory loss in older adults. It is for individuals aged 60-85 who have mild memory impairment. Participants will use a home device that plays sounds during sleep for two 4-week periods, alternating between real and fake (soundless) stimulation. Alternatives include lifestyle changes, memory exercises, and medications, though this study explores a novel non-drug approach. The trial aims to enroll 60 participants.
Official Summary
This study aims to explore a non-invasive way to improve memory and slow cognitive decline in older adults by enhancing sleep quality. Dementia, a leading cause of death worldwide, is often associated with disturbed sleep, particularly the loss of deep, slow-wave sleep (SWS). SWS is important for memory and clearing waste from the brain. Poor SWS can worsen memory loss and allow harmful waste to build up, which may increase the risk of dementia. The investigators are testing whether phase-locked auditory stimulation (PLAS) can improve SWS in people at a mild stage of cognitive impairment. PLAS uses short sounds played at specific moments to strengthen slow-wave brain activity during sleep. The investigators previous laboratory based research has shown that this can improve memory and help with clearing waste from the brain. Now, the investigators want to test this in a real-world setting, over a longer period, which is unfeasible in a laboratory setting. In this study, 60 older adults will use home-use devices that deliver either real or sham (soundless) PLAS across two different 4-week periods. Memory will be tested using engaging "serious games." Before and after each experimental period, blood samples will be taken to measure dementia-related markers, and cognitive batteries will be performed. The investigators expect that PLAS will improve sleep, and that this will have a downstream effect on memory and brain clearance, potentially slowing the process of cognitive decline. If successful, this could lead to the development of an affordable treatment that helps people maintain brain health and prevent dementia.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 60 and 85 years old and have mild memory issues. You must be a fluent German speaker with normal vision and hearing. You cannot join if you have severe sleep problems like insomnia, sleep apnea, or restless leg syndrome, or significant depression or other neurological/psychiatric conditions. A family member or close friend living with you will need to help you use the study devices. This trial is studying Cognitive Decline, Alzheimer Disease, Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), Cognitive Impairment, Mild, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how well participants' memory improves after using the sound stimulation device, indicating its potential to help maintain cognitive function. The specific primary outcome measures are: Episodic memory performance differences (between and within subject) according to the experimental condition (Participants will play serious games on weekdays during the adaptation week, as well as on weekdays throughout both the first and second 4-week intervention periods.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses the significant gap in dementia prevention by investigating a non-invasive, drug-free method to enhance sleep quality, which is crucial for memory and brain health. This research targets Cognitive Decline, Alzheimer Disease, Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), Cognitive Impairment, Mild, where improved treatment options are needed.
Investor Insight
This trial signals a growing interest in non-pharmacological interventions for cognitive decline, a large and expanding market, with potential for a novel, low-risk treatment.
Is This Trial Right for Me?
Ask your doctor if this trial is right for you, especially regarding your sleep quality and memory concerns. You will use a special device at home that plays sounds during sleep for two 4-week periods, with a break in between. You will play memory games and have blood samples taken before and after each 4-week period. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: CROSSOVER
- Masking: SINGLE
- Enrollment: 60 participants
Interventions
- OTHER: Phase-locked auditory stimulation (PLAS) — Intervention: Verum Phase-Locked Auditory Stimulation (PLAS) Using the SleepLoop Device. The experimental intervention utilizes the SleepLoop device, a home-use, EEG-based system designed for phase-locked acoustic stimulation (PLAS). The device continuously monitors sleep through EEG (Fpz) alongside electrooculogram (EOG) and electromyogram (EMG) channels. The device employs a closed-loop algorithm that detects slow oscillations (SOs) in the EEG and delivers short sound stimuli (50 ms pink nois
- OTHER: Sham Phase-Locked Auditory Stimulation — Participants will undergo the same procedure as the real Phase-Locked Auditory Stimulation (PLAS) intervention. However, during the sham condition, the headphones are turned off, and no auditory stimulation is delivered.
Primary Outcomes
- Episodic memory performance differences (between and within subject) according to the experimental condition (Participants will play serious games on weekdays during the adaptation week, as well as on weekdays throughout both the first and second 4-week intervention periods.)
Secondary Outcomes
- Electrophysiological Response - Event-Related Potentials (ERPs) (Sleep-Electrophysiology will be measured on weekdays during the adaptation week, as well as on weekdays throughout both the first and second 4-week intervention periods.)
- Electrophysiological Response - Power, Number, and Amplitude of Slow Oscillations (SO) and Spindles (Sleep-electrophysiology will be measured on weekdays during the adaptation week, as well as on weekdays throughout both the first and second 4-week intervention periods.)
- Electrophysiological Response - Coupling of Slow Oscillations and Sleep Spindles (Sleep-electrophysiology will be measured on weekdays during the adaptation week, as well as on weekdays throughout both the first and second 4-week intervention periods.)
- Amyloid-Beta Response (At baseline, after 4 weeks, after 6 weeks, after 10 weeks)
- Electrophysiology - Brain Age Estimation (Sleep electrophysiology will be measured on weekdays during the adaptation week and on weekdays throughout both the first and second 4-week intervention periods.)
Full Eligibility Criteria
Inclusion Criteria: * Written informed consent * Age between 60 and 85 years * Cognitive impairment (subjective and/or MoCA between 23-26) * Native German speakers or comparably fluent * Normal or corrected-to-normal vision. * Intact hearing * A close cohabitant (partner/sibling) should be present to support participants in using study materials/devices. Exclusion Criteria: * Insomnia assessed by the Regensburg Insomnia Scale (RIS; Crönlein et al., 2013) * Restless leg syndrome assessed by questions concerning typical symptoms. * Sleep apnoea assessed by the Berlin Questionnaire (BQ; Netzer et al., 1999) * Severely irregular sleep patterns assessed by the RIS and the Pittsburgh sleep quality index (PSQI; Buysse et al., 1989) * Symptoms of depression (Geriatric Depression Scale (GDS; Yesavage et al., 1982) ≥ 5) * History of untreated severe neurological and psychiatric diseases * Alcohol or substance abuse * Use of medication acting on the central nervous system
Trial Locations
- University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland
Frequently Asked Questions
What is clinical trial NCT06669546?
NCT06669546 is a Not Applicable INTERVENTIONAL study titled "Effects of Real vs. Soundless Acoustic Stimulation During Deep Sleep on Brain Activity, Memory, and Blood Biomarkers in Older Adults (60-85) With Mild Memory Impairment." It is currently recruiting and is sponsored by University of Bern. The trial targets enrollment of 60 participants.
What conditions does NCT06669546 study?
This trial investigates treatments for Cognitive Decline, Alzheimer Disease, Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), Cognitive Impairment, Mild. The primary condition under study is Cognitive Decline.
What treatments are being tested in NCT06669546?
The interventions being studied include: Phase-locked auditory stimulation (PLAS) (OTHER), Sham Phase-Locked Auditory Stimulation (OTHER). Intervention: Verum Phase-Locked Auditory Stimulation (PLAS) Using the SleepLoop Device. The experimental intervention utilizes the SleepLoop device, a home-use, EEG-based system designed for phase-locked acoustic stimulation (PLAS). The device continuously monitors sleep through EEG (Fpz) alongside electrooculogram (EOG) and electromyogram (EMG) channels. The device employs a closed-loop algorithm that detects slow oscillations (SOs) in the EEG and delivers short sound stimuli (50 ms pink nois
What does Not Applicable mean for NCT06669546?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06669546?
This trial is currently "Recruiting." It started on 2025-02-21. The estimated completion date is 2028-12.
Who is sponsoring NCT06669546?
NCT06669546 is sponsored by University of Bern. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06669546?
The trial aims to enroll 60 participants. The trial is currently recruiting and accepting new participants.
How is NCT06669546 designed?
This is a interventional study, uses randomized allocation, follows a crossover design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06669546?
The primary outcome measures are: Episodic memory performance differences (between and within subject) according to the experimental condition (Participants will play serious games on weekdays during the adaptation week, as well as on weekdays throughout both the first and second 4-week intervention periods.). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06669546 being conducted?
This trial is being conducted at 1 site, including Bern (Switzerland).
Where can I find official information about NCT06669546?
The official record for NCT06669546 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06669546. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06669546 testing in simple terms?
This trial tests if special sounds played during deep sleep can improve memory and slow down memory loss in older adults. It is for individuals aged 60-85 who have mild memory impairment.
Why is this trial significant?
This trial addresses the significant gap in dementia prevention by investigating a non-invasive, drug-free method to enhance sleep quality, which is crucial for memory and brain health.
What are the potential risks of participating in NCT06669546?
The main risks are related to the sleep device, though it is designed to be non-invasive. Potential side effects are generally mild and could include temporary sleep disturbances or discomfort from wearing the device. There is a small risk that the stimulation may not be effective for everyone. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06669546?
Ask your doctor if this trial is right for you, especially regarding your sleep quality and memory concerns. You will use a special device at home that plays sounds during sleep for two 4-week periods, with a break in between. You will play memory games and have blood samples taken before and after each 4-week period. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06669546 signal from an investment perspective?
This trial signals a growing interest in non-pharmacological interventions for cognitive decline, a large and expanding market, with potential for a novel, low-risk treatment. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will use a home device that plays sounds during sleep for two 4-week periods, alternating between real and fake (soundless) stimulation. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.