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NCT Number: NCT07672977

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

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.

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Key information

Conditions

MCI-AD, Early Stage Alzheimer's Disease AD AD-MCI Alzheimer s Disease Cognition Disorders Cognitive Dysfunction Mental Disorders Mild Cognitive Impairment (MCI) Amnestic Neurocognitive Disorders

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bit&Brain Technologies SL

Zaragoza, 50006, Spain

About this study

Alzheimer's disease (AD) is characterized by progressive cognitive decline and is preceded by a prodromal stage known as amnestic mild cognitive impairment due to AD (MCI-AD), in which early neurophysiological alterations are detectable. Among these, disruptions in sleep architecture-particularly reductions in slow-wave activity (SWA; ~0.5-4 Hz) and sleep spindle activity (~11-16 Hz)-have been associated with impaired memory consolidation and the progression of AD-related pathophysiological processes.

Closed-loop auditory stimulation during sleep (CLAS) is a non-invasive neuromodulation approach that delivers precisely timed auditory stimuli phase-locked to endogenous slow oscillations, with the aim of enhancing slow-wave activity and associated thalamocortical spindle dynamics. This targeted entrainment of sleep oscillations may improve sleep-dependent neural processes and represents a potential therapeutic strategy in the early stages of AD.

The present study is an open-label, single-arm investigation designed to evaluate the effects of home-based CLAS in patients with biomarker-confirmed amnestic mild cognitive impairment due to Alzheimer's disease (MCI-AD). The intervention is self-administered in the participants' home environment. All participants complete an initial treatment period of 3 months followed by a one-month off-treatment (washout) period to assess persistence of effects. Participants who elect to continue may then enter an optional extension phase consisting of 3 additional months of treatment, followed by a second one-month off-treatment period. The total study duration is approximately 4 months for participants completing the initial phase only, or approximately 8 months for those completing the extension phase.

The primary objective is to assess target engagement, defined as the modulation of NREM sleep electrophysiological activity, with particular focus on slow-wave sleep. More precisely, sustained increases in slow-wave activity across the intervention period will be quantified using the study EEG device during intervention nights.

Secondary objectives include evaluation of adherence to the intervention, usability of the device in the home environment, and safety and tolerability. Exploratory objectives include evaluation of the intervention's effects on clinical, functional, cognitive, and sleep-related outcomes, as well as blood-based biomarkers. Clinical, functional, and cognitive variables will be assessed at three time points: before intervention (baseline, Month 0), at the end of the initial treatment period (Month 3), and, for participants entering the extension phase, at the end of the extended treatment period (Month 7).

Blood biomarkers will be obtained at the following time points: baseline (Month 0), end of the initial treatment period (Month 3), and end of the first washout period (Month 4). Participants entering the extension phase will have two additional blood draws: at the end of the extended treatment period (Month 7) and at the end of the second washout period (Month 8). Sleep metrics, derived from EEG recordings or subjective responses to digitized questionnaires, will be acquired daily using the home-based study device.

This study does not include randomization or a sham control group; all participants receive active treatment during intervention periods. The results are expected to provide evidence on neurophysiological target engagement, feasibility, safety, and the clinical and biological effects of home-based CLAS as a therapeutic strategy in early-stage AD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 structural brain damage.
  • Unable to read and write in Spanish.
  • Inability to use the study device effectively, as determined during the screening session. This includes, but is not limited to, anatomical or dermatological factors preventing adequate electrode placement, or excessive EEG signal artifacts that prevent reliable detection of sleep oscillations.

Treatment and study plan

Closed-loop auditory stimulation

Device

The system delivers brief auditory stimuli (pink noise bursts) that are time-locked to the up-phase of endogenous slow oscillations during non-rapid eye movement (NREM) sleep, as detected in real time using electroencephalography (EEG). Stimulation is withheld in approximately half of detected slow oscillations (Sham) to serve as a within-session control condition for the acute effects of stimulation. The other half of the slow oscillations are stimulated at a volume between 30-60 dB (Stim), which is personalized to the patient and adapts during the night to improve response while reducing awakenings.

The objective of the stimulation is to enhance slow-wave activity (SWA) during deep sleep through phase-specific entrainment of endogenous slow-wave activity.

The intervention is self-administered using a portable system adapted for use in patients with MCI. Participants are instructed to use the device for as many nights as possible throughout the study period.

Other names: AudiStim

Primary outcomes

  1. Target Engagement: Sustained Increase in Slow-Wave Activity During N2-N3 Sleep

    Time frame: 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).

    Within-subject difference in mean slow-wave activity during N2-N3 sleep between stimulation and sham conditions, computed nightly and aggregated across the intervention period. The sustained effect will be evaluated as the consistency of the stimulation-induced increase in slow-wave activity across nights throughout the intervention period.

Secondary outcomes

  1. Sustained Increase in Spindle Activity During N2-N3 Sleep

    Time frame: 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).

    Within-subject difference in spindle activity (spindle occurrence during N2-N3 sleep) between stimulation and sham conditions, computed nightly and aggregated across the intervention period. The sustained effect will be evaluated as the consistency of the stimulation-induced increase in spindle activity across nights throughout the intervention period.

  2. Adherence to the Intervention

    Time frame: Computed as a summary measure over each participant's full intervention period (3 months, or up to 7 months for participants entering the extension phase).

    Average number of intervention nights attempted per week. An intervention night is defined as a night during which the participant initiates use of the technology. Adherence will also be summarized as the proportion of participants achieving an average of at least 4 nights per week.

  3. Usability of the Closed-Loop Auditory Stimulation System

    Time frame: Computed as a summary measure over each participant's full intervention period (3 months, or up to 7 months for participants entering the extension phase).

    Percentage of successful sessions among all attempted sessions. A successful session is defined as one in which the participant correctly sets up the device, the system initializes, and usable physiological data are recorded. Sessions may be unsuccessful due to patient-side factors (e.g., electrode placement errors), device-side factors (e.g., technical malfunction), or both.

  4. Safety and Tolerability

    Time frame: Continuously monitored from enrollment through the end of participation, with summary analyses at 3 months and, for participants entering the extension phase, at 7 months.

    Incidence, severity, and relatedness of adverse events associated with the intervention, including sleep disturbance, discomfort related to auditory stimulation, and any device-related adverse effects. Safety will be assessed continuously and summarized at interim and final analyses.

Other outcomes

  1. Cognitive Performance - Alzheimer's Disease Assessment Scale-Cognitive Subscale, 11-item version (ADAS-Cog 11)

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).

    Change from baseline in global cognitive performance, as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 11-item version (ADAS-Cog 11). Scores range from 0 to 70, with higher scores indicating poorer cognitive performance.

  2. Functional Ability - Alzheimer's Disease Cooperative Study-Activities of Daily Living scale for Mild Cognitive Impairment (ADCS-ADL-MCI)

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).

    Change from baseline in activities of daily living measured using the Alzheimer's Disease Cooperative Study-Activities of Daily Living scale for Mild Cognitive Impairment (ADCS-ADL-MCI). Scores range from 0 to 69; higher scores indicate better functional ability.

  3. Global Cognition - MoCA

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).

    Change from baseline in global cognitive function, as measured by the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive performance.

  4. Episodic Memory - Rey Auditory Verbal Learning Test (RAVLT) Total Learning Score (Trials 1-5)

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).

    Change from baseline in episodic memory performance, assessed using the Rey Auditory Verbal Learning Test (RAVLT) total learning score (Trials 1-5). Scores range from 0 to 75, with higher scores indicating better episodic memory performance.

  5. Immediate Memory - Wechsler Memory Scale-Fourth Edition (WMS-IV) Logical Memory I

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).

    Change from baseline in immediate memory performance, assessed using the Wechsler Memory Scale-Fourth Edition (WMS-IV) Logical Memory I subtest. Scores range from 0 to 53, with higher scores indicate better immediate memory performance.

  6. Episodic Memory - Wechsler Memory Scale-Fourth Edition (WMS-IV) Logical Memory II

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)

    Change from baseline in episodic memory performance, assessed using the Wechsler Memory Scale-Fourth Edition (WMS-IV) Logical Memory II subtest. Scores range from 0 to 39, with higher scores indicate better episodic memory performance.

  7. Immediate Memory - Wechsler Memory Scale-Fourth Edition (WMS-IV) Verbal Paired Associates I

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)

    Change from baseline in immediate memory performance, assessed using the Wechsler Memory Scale-Fourth Edition (WMS-IV) Verbal Paired Associates I subtest. Scores range from 0 to 40, with higher scores indicate better immediate memory performance.

  8. Episodic Memory - Wechsler Memory Scale-Fourth Edition (WMS-IV) Verbal Paired Associates II

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).

    Change from baseline in episodic memory performance, assessed using the Wechsler Memory Scale-Fourth Edition (WMS-IV) Verbal Paired Associates II subtest. Scores range from 0 to 10, with higher scores indicate better episodic memory performance.

  9. Visual Reproduction - Wechsler Memory Scale-Fourth Edition (WMS-IV) Visual Reproduction I

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)

    Change from baseline in visual memory performance, assessed using the Wechsler Memory Scale-Fourth Edition (WMS-IV) Visual Reproduction I subtest. Scores range from 0 to 43, with higher scores indicating better visual memory performance.

  10. Visual Reproduction - Wechsler Memory Scale-Fourth Edition (WMS-IV) Visual Reproduction II

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)

    Change from baseline in visual memory performance, assessed using the Wechsler Memory Scale-Fourth Edition (WMS-IV) Visual Reproduction II subtest. Scores range from 0 to 43, with higher scores indicating better visual memory performance.

  11. Working Memory - Wechsler Memory Scale-Fourth Edition (WMS-IV) Symbol Span

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)

    Change from baseline in working memory performance, assessed using the Wechsler Memory Scale-Fourth Edition (WMS-IV) Symbol Span subtest. Scores range from 0 to 50, with higher scores indicating better working memory performance.

  12. Working Memory - Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Digit Span

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).

    Change from baseline in working memory, assessed using the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Digit Span subtest. Scores range from 0 to 48, with higher scores indicating better working memory performance

  13. Working Memory - Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Arithmetic

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)

    Change from baseline in working memory, assessed using the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Arithmetic subtest. Scores range from 0 to 22, with higher scores indicating better working memory performance.

  14. Processing Speed - Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Symbol Search

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7)

    Change from baseline in processing speed, assessed using the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Symbol Search subtest. Scores range from 0 to 60, with higher scores indicating better processing speed performance.

  15. Processing Speed - Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Coding

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).

    Change from baseline in processing speed, assessed using the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) Coding subtest. Scores range from 0 to 135, with higher scores indicating better processing speed performance.

  16. Anxiety Symptoms - Goldberg Anxiety Scale

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).

    Change from baseline in anxiety symptoms, measured using the Goldberg Anxiety Scale. Scores range from 0 to 9, with higher scores indicating worse anxiety symptoms.

  17. Depressive Symptoms - PHQ-8

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).

    Change from baseline in depressive symptoms, measured using the Patient Health Questionnaire-8 (PHQ-8). Scores range from 0 to 24, with higher scores indicating greater symptom severity.

  18. Patient Self-Reported Experience (Daily)

    Time frame: Assessed daily on intervention days, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).

    Daily subjective cognitive and affective experience assessed using Temporal Experience Tracing (TET). TET is a visual-analog method in which participants retrospectively graph the intensity of an experience along several phenomenological dimensions over time, producing daily compositional profiles of cognitive and emotional states.

  19. Sleep macrostructure - Sleep duration

    Time frame: 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).

    Change from baseline in sleep duration, estimated from EEG recordings. The duration of sleep will be quantified as the Time In Bed (TIB), defined as the full length from the start to the end of the recording; Sleep Period Time (SPT), from the first to the last epoch of sleep; and Total Sleep Time (TST), the cumulative duration of all sleep stages (N1, N2, N3, and REM). Sleep duration will be quantified in minutes.

    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.

  20. Sleep macrostructure - Percentage of Time per Sleep Stage

    Time frame: 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).

    Change from baseline in the distribution of sleep stages (%): N1, N2, N3, REM, Wake, estimated from EEG recordings. The time spent in each sleep stage will be reported with respect to sleep time, in percentage.

    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.

  21. Sleep macrostructure - Efficiency of sleep

    Time frame: 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).

    Change from baseline in efficiency of sleep, estimated from EEG recordings. Sleep Efficiency (SE) constitutes the ratio between total sleep time and time in bed, whereas Sleep Maintenance Efficiency (SME) is the ratio between total sleep time and sleep period time, representing the proportion of time spent alseep.

    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.

  22. Sleep macrostructure - Wake after sleep onset

    Time frame: 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).

    Change from baseline in time spent awake after the onset of sleep, estimated from EEG recordings. Wake After Sleep Onset (WASO) is the accumulated wake time (in minutes) within sleep period 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.

  23. Sleep macrostructure - Sleep onset latency

    Time frame: 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).

    Change from baseline in sleep onset latency, estimated from EEG recordings. Sleep Onset Latency (SOL) is the time in minutes from the start of the recording to the first epoch of sleep. This metric can also be computed for each individual sleep stage (N1, N2, N3, and REM), measured from the start of the recording to the first occurrence of that 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.

  24. Sleep macrostructure - Sleep fragmentation

    Time frame: 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).

    Change from baseline in sleep fragmentation, estimated from EEG recordings. Sleep fragmentation is measured as the number of sleep stage changes (i.e., the number of transitions between diferent stages) througout the night. The number of transitions from any sleep stage (N1, N2, N3, REM) to wake constitute the number of awakenings.

    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.

  25. Subjective Sleep Quality - PSQI

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).

    Change from baseline in self-reported sleep quality, measured using the Pittsburgh Sleep Quality Index (PSQI). Global scores range from 0 to 21, with higher scores indicating poorer sleep quality.

  26. Subjective Sleep Quality - ISI

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), and end of extension treatment (Month 7).

    Change from baseline in insomnia severity, measured using the Insomnia Severity Index (ISI). Scores range from 0 to 28, with higher scores indicating more severe insomnia.

  27. Daytime Sleepiness

    Time frame: Assessed daily on intervention days, from baseline through the end of the intervention period (3 months, or up to 7 months for participants entering the extension phase).

    Daily self-reported daytime sleepiness assessed using the Stanford Sleepiness Scale (SSS). Scores range from 1 to 7, with higher scores indicating greater sleepiness.

  28. Plasma Amyloid Pathology - Amyloid-Beta 42/40 Ratio

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).

    Change from baseline in plasma amyloid-beta 42/40 ratio, assessed to characterize within-subject temporal dynamics across intervention and washout periods. Higher values indicate a higher amyloid-beta 42/40 ratio.

  29. Plasma Phosphorylated Tau 217 (p-tau217)

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8)

    Percent change from baseline in plasma phosphorylated tau 217 (p-tau217). Values will be reported as percent change (%), with negative values representing decreases and positive values representing increases relative to baseline.

  30. Plasma Neurodegeneration Biomarker - Glial Fibrillary Acidic Protein (GFAP)

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).

    Percent change from baseline in plasma glial fibrillary acidic protein (GFAP), assessed to characterize within-subject temporal dynamics across intervention and washout periods. Values will be reported as percent change (%); negative values indicate a decrease and positive values indicate an increase in circulating GFAP levels relative to baseline.

  31. Plasma Neurodegeneration Biomarker - Neurofilament Light Chain (NfL)

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).

    Percent change from baseline in plasma neurofilament light chain (NfL), assessed to characterize within-subject temporal dynamics across intervention and washout periods. Values will be reported as percent change (%); negative values indicate a decrease and positive values indicate an increase in circulating NfL levels relative to baseline.

  32. Plasma Inflammatory Biomarker - Interleukin-6 (IL-6)

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8)

    Percent change from baseline in plasma interleukin-6 (IL-6), assessed to characterize within-subject temporal dynamics across intervention and washout periods. Values will be reported as percent change (%); negative values indicate a decrease and positive values indicate an increase in circulating IL-6 levels relative to baseline.

  33. Plasma Inflammatory Biomarker - Interleukin-10 (IL-10)

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).

    Percent change from baseline in plasma interleukin-10 (IL-10), assessed to characterize within-subject temporal dynamics across intervention and washout periods. Values will be reported as percent change (%); negative values indicate a decrease and positive values indicate an increase in circulating IL-10 levels relative to baseline.

  34. Plasma Inflammatory Biomarker - Tumor Necrosis Factor Alpha (TNF-alpha)

    Time frame: Assessments at baseline (Month 0), end of initial treatment (Month 3), end of first washout (Month 4), end of extension treatment (Month 7), and end of second washout (Month 8).]

    Percent change from baseline in plasma tumor necrosis factor alpha (TNF-alpha), assessed to characterize within-subject temporal dynamics across intervention and washout periods. Values will be reported as percent change (%); negative values indicate a decrease and positive values indicate an increase in circulating TNF-alpha levels relative to baseline.

Sponsors and collaborators

Lead sponsor

Bitbrain

Industry

Registry information

Acronym: Nana-Home

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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