Status:
NOT_YET_RECRUITING
Yoga-based, Movement Therapy Device as Noninvasive Glymphatic Clearance Augmentation in Alzheimer's Disease.
Lead Sponsor:
CIATRIX, INC.
Collaborating Sponsors:
University of Oulu
Conditions:
Alzheimer Disease
Mild Cognitive Impairment (MCI)
Eligibility:
All Genders
55+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 slowi...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06989242
Start Date
July 1 2025
End Date
May 1 2026
Last Update
July 10 2025
Active Locations (3)
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1
Neuro Health Centrum S.R.O
Brno, Czechia, 62800
2
Neuropsychiatrie s.r.o., Terronska 580/19
Prague, Czechia, 16000
3
AuraMedica s.r.o., Neurologická ambulancia, OMNIA BUSINESS CENTER, Tomášikova 19081/28C
Bratislava, Slovakia, Slovakia, 821 01