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Home-Based Closed-Loop Auditory Stimulation to Enhance Slow-Wave Activity in MCI Due to Alzheimer's Disease: A Proof-of-Concept Study

Study acronym: Nana-Home
StatusEnrolling by Invitation
PhaseNot applicable
SponsorBitbrain
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
Bitbrain
3 trials monitored
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Dementia
1,978 trials monitored
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Alzheimer's Disease
1,253 trials monitored
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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.
Trial Details
NCT Number NCT07672977
Lead Sponsor Bitbrain
Conditions
(from sponsor)		 MCI-AD, Early Stage Alzheimer's Disease, Alzheimer s Disease, Mild Cognitive Impairment (MCI) Amnestic, AD, AD-MCI
Related terms Cognitive Dysfunction
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov