Набор скоро начнётся NCT06989242

Yoga-based, Movement Therapy Device as Noninvasive Glymphatic Clearance Augmentation in Alzheimer's Disease.

Без фазы С лечением Alzheimer Disease Mild Cognitive Impairment (MCI)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Yoga-Based Therapeutic Device (incorporating guided breathing and movement).
Кому может быть актуально: Состояния в реестре: Alzheimer Disease, Mild Cognitive Impairment (MCI). Базовые параметры: от 55 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Чехия, Словакия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Yoga-based, Movement Therapy Device as Noninvasive Glymphatic Clearance Augmentation in Alzheimer's Disease. The Feasibility and Safety Trial With Preliminary Clinical, Digital, and Fluid Biomarker Proxies of Glymphatic Clearance

Обзор

This clinical trial evaluates a yoga-based intervention delivered through a powered therapeutic device designed to guide breathing and body movements. Building on evidence that mind-body practices may promote healthy aging, cognitive function, and glymphatic flow, the study uses physiological measurements, including fNIRS and wearable sensors, to investigate mechanisms and potential benefits in individuals at risk for Alzheimer's disease.

Подробное описание

Brief Summary:

The current trial builds on recent findings that highlight the effectiveness of mind-body interventions, such as yoga and deep abdominal breathing, in promoting healthy aging and slowing cognitive decline. Research suggests that yoga and body-mind practices can improve well-being and reduce biological markers of aging in both healthy older adults and those at risk for dementia. Yogic breathing and body movements may enhance cerebrospinal fluid (CSF) flow as an important component of the glymphatic function. The trial employs physiological measurements, including fNIRS and wearable sensors, to investigate the mechanisms and clinical benefits of yoga-based interventions for AD.

The primary objective is to assess the safety, tolerability, feasibility of a 4-week Fluere™ therapy protocol for stage 3 and 4 AD patients.

The secondary objectives focus on clinical effectiveness related to:

1. Body posture improvement 2. Changes in HRV (reflecting the stress level and quality of sleep)

Although the duration of the study is short, and the study is not powered to detect changes in biomarkers or clinical efficacy, secondary endpoints will be analyzed to assess trends in improvement from baseline.

Additional secondary outcomes will focus on biomarker proxies of glymphatic clearance:

1. Impact on digital biomarkers (neuro-fluid dynamics (hemodynamics, CSF) and redox state of cytochrome-c-oxidase activity using fNIRS) 2. Effect on plasma biomarkers associated with neurodegeneration, inflammation and neural plasticity - GFAP, NfL and S100B and BDNF 3. Cognitive (spatial memory) and functional outcomes 4. Sleep patterns and quality through wearable devices and questionnaires

Вмешательства

Устройство Yoga-Based Therapeutic Device (incorporating guided breathing and movement)
The Fluere™ Therapeutic Device is a computer-guided, electro-mechanical system designed to simulate yoga-inspired spinal movement and rhythmic breathing. Resembling a dental chair, the device dynamically adjusts spinal curvature to replicate motion patterns associated with deep abdominal breathing, similar to Kundalini or Qi Gong breathwork. The device operates automatically, with optional manual adjustments by the researcher.

Первичные конечные точки

Number and type of intervention-related adverse events as assessed by a yoga-specific adverse events questionnaire [Срок оценки: Throughout the 4-week intervention period]
Number of participants completing ≥90% of scheduled intervention sessions [Срок оценки: 4 weeks (intervention period)]
Mean percentage of completed intervention sessions per participant [Срок оценки: 4 weeks (intervention period)]
Number of participants who withdraw from the study before completing intervention [Срок оценки: 4 weeks (intervention period)]

Вторичные конечные точки (12)

Change in Heart Rate Variability During Therapy over time [Срок оценки: During each session across 4 weeks]
Change in vertical postural alignment as measured by digital posture analysis [Срок оценки: Baseline and 4 timepoints altogether corresponding to 4 treatment weeks]
Change in spine flexibility as measured by the Thomayer test (in cm) [Срок оценки: Baseline and weekly]
Change in nightly average heart rate variability (SMSSD) during sleep as measured by wearable sensors in Milliseconds (ms) [Срок оценки: Nightly, throughout the 4-week study period]
Change in nightly average resting heart rate during sleep as measured by wearable sensors (in bpm) [Срок оценки: Nightly, throughout the 4-week study period]
Change in nightly average respiratory rate (Breaths per minute) during sleep as measured by wearable sensors [Срок оценки: Nightly, throughout the 4-week study period]
Change in cortical hemodynamic activity (HbO and HbR concentrations) at rest and during intervention, measured by fNIRS [Срок оценки: Baseline, Week 4, and during each intervention session]
Change in cortical water signal (tissue hydrodynamics) measured by H2O-specific wavelength sensor [Срок оценки: Baseline, Week 4, and during each intervention session]
Change in oxidation state of cytochrome c oxidase measured by broadband fNIRS [Срок оценки: Baseline, Week 4, and during each intervention session]
Change in nightly sleep stage distribution as measured by PPG-based wearable sensors - Percentage of total sleep time in each of the sleep stages [Срок оценки: Nightly, over the 4-week intervention period]
Change in sleep quality subscale score (B-PSQI) from the GlymphActive Questionnaire [Срок оценки: Baseline and Week 4]
Change in spatial navigation performance (corrent responses) as measured by the Intersections Spatial Memory Cognitive Task [Срок оценки: Familiarization at screening, Baseline and Week 4]

Критерии участия

Критерии включения

55-85 years of age
Current diagnostic criteria for stage 3 AD patients (AD-MCI)
Current diagnostic criteria for stage 4 AD patients (mAD)
Able to provide consent to be in the study
Willing and able to participate in study activities
Able to lay supine for 30-45 minutes
Able to walk 20 meters
Willing to not perform additional mind-body practices during the duration of the study
Able to use a wearable electronic device (Smart watch)

Критерии исключения

Inability to provide informed consent
Regular use of muscle relaxants or anti-anxiety drugs
Any muscle or skeletal issues that would make it difficult to lie still in the supine position for the 1-hour physical therapy
Craniospinal disorders, e.g., Chiari Malformation.
Spinal injuries, clinically relevant disc herniation, spinal stenosis, spondylolisthesis in the sacral, lumbar, thoracic, or cervical spine, spinal bifida, Recent Spinal Surgery
Severe osteoporosis with a risk of fracture
History of neurological disorders such as stroke (during the last year before study start), mild brain injury within past 6 months, multiple sclerosis, presence of intracranial hemorrhage, hydrocephalus, meningitis, encephalitis, brain tumor (except of asymptomatic meningioma GI)
Serious sleep disorders - narcolepsy
Major or uncontrolled psychiatric illness or major depression.
Any condition requiring the use of medication that acts on the brain such as stimulants, sedatives (hypnotics and benzodiazepines), antipsychotics, and anti-anxiety medications, (we will include patients with stable antidepressant treatment and being on mild anti-seizure medication due to polyneuropathy)
Active infection or uncontrolled significant systemic illnesses
Asthma, chronic obstructive pulmonary disease
Recent hearth attack, Implantable defibrillator, poorly controlled blood pressure cardiac arrhythmia, unstable angina pectoris, or symptomatic congestive heart failure
People at risk of blood clots or deep vein thrombosis (DVT) might want to avoid prolonged sitting in the chair
Obesity over 135 kg (300lb)
Smoking more than 5 cigarettes a day or drinking more than 1 alcoholic beverage a day

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет