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

NCT06989242 | Not Yet Recruiting

• 1 other identifier: RG-CZSK-PH2
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 3

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 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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment (MCI)

Keywords

Mind-Body Intervention; Medical Device; CSF flow; fNIRS; Feasibility Study; Alzheimer disease

Outcome Measures

Primary Outcomes (4)

• Number and type of intervention-related adverse events as assessed by a yoga-specific adverse events questionnaire

  Safety will be evaluated using a standardized yoga-specific adverse events questionnaire administered after each session. Adverse events will be recorded, categorized (e.g., musculoskeletal, autonomic, psychological), and summarized by frequency and severity. Only events judged as related to the intervention will be included.

  Throughout the 4-week intervention period

• Number of participants completing ≥90% of scheduled intervention sessions

  Feasibility of the intervention will be assessed by the number of participants who attend at least 90% of scheduled sessions (i.e., ≥11 out of 12 sessions). Reported as count and percentage of total enrolled participants.

  4 weeks (intervention period)

• Mean percentage of completed intervention sessions per participant

  Calculated as the average percentage of completed sessions per participant across the study population. This reflects session adherence at the group level.

  4 weeks (intervention period)

• Number of participants who withdraw from the study before completing intervention

  The dropout rate will be determined by the number of participants who discontinue the study before completing all planned sessions, regardless of reason.

  4 weeks (intervention period)

Secondary Outcomes (22)

• Change in Heart Rate Variability During Therapy over time

  During each session across 4 weeks

• Change in vertical postural alignment as measured by digital posture analysis

  Baseline and 4 timepoints altogether corresponding to 4 treatment weeks

• Change in spine flexibility as measured by the Thomayer test (in cm)

  Baseline and weekly

• Change in nightly average heart rate variability (SMSSD) during sleep as measured by wearable sensors in Milliseconds (ms)

  Nightly, throughout the 4-week study period

• Change in nightly average resting heart rate during sleep as measured by wearable sensors (in bpm)

  Nightly, throughout the 4-week study period

Study Arms (1)

Intervention Arm - Device-Guided Movement and Breathing

EXPERIMENTAL

Participants in this arm will receive a yoga-based intervention delivered through a powered therapeutic device that guides rhythmic breathing and spinal movement. The intervention is designed to mimic traditional yoga poses such as Marjariasana (cat-cow) and is conducted over multiple sessions. The study aims to assess feasibility, safety, and preliminary effects on cognitive function, physiological measures (e.g., fNIRS, HRV, posture), and fluid biomarkers in individuals with Alzheimer's disease (stages 3 and 4).

Device: Yoga-Based Therapeutic Device (incorporating guided breathing and movement)

Interventions

Yoga-Based Therapeutic Device (incorporating guided breathing and movement) DEVICE

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.

Also known as: Rhythmic Breathing and Spinal Mobilization Chair

Intervention Arm - Device-Guided Movement and Breathing

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• CIATRIX, INC.: lead
• University of Oulu: collaborator

Study Sites (3)

Neuro Health Centrum S.R.O

Brno, 62800, Czechia

Location

Neuropsychiatrie s.r.o., Terronska 580/19

Prague, 16000, Czechia

Location

AuraMedica s.r.o., Neurologická ambulancia, OMNIA BUSINESS CENTER, Tomášikova 19081/28C

Bratislava, Slovakia, 821 01, Slovakia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Patrik Simko, MA. PhD.

  Masaryk University, The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC), CIATRIX Inc.

  STUDY DIRECTOR

• Katerina Sheardova, MD. PhD.

  The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrik Simko PhD., MA. PhD.

CONTACT

+420774846288; patrik.simko@ciatrix.com

Katerina Sheardova MD, PhD., MD, PhD.

CONTACT

ksheardova@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No other parties who are masked are involved in this clinical trial.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-arm interventional feasibility and safety study evaluating a yoga-based therapeutic device in individuals diagnosed with Alzheimer's disease (stages 3 and 4). The intervention combines guided movement and rhythmic breathing. The study assesses feasibility, safety, and preliminary effects on cognitive function, physiological markers (e.g., fNIRS, HRV, posture), and fluid biomarkers.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 25, 2025
• Study Start: July 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: May 1, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

SL (1); CZ (2)