Alzheimer DiseaseReGlydeNCT06989242
Yoga-based, Movement Therapy Device as Noninvasive Glymphatic Clearance Augmentation in Alzheimer's Disease.
A study testing Yoga-Based Therapeutic Device (incorporating guided breathing and movement) in people with Alzheimer Disease and Mild Cognitive Impairment (MCI), run by CIATRIX, INC. at 3 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment (MCI)
- What is being tested?
- Yoga-Based Therapeutic Device (incorporating guided breathing and movement)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jul 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Katerina Sheardova MD, PhD., MD, PhD. contact
3 sites in 2 countries
Czechia2 sites
Neuro Health Centrum S.R.O
Brno, 62800
Monika Kurečková, Ing., +420544134246, neurohealthcz@gmail.com
Katerina Sheardova, MD, PhD.
Neuropsychiatrie s.r.o., Terronska 580/19
Prague, 16000
Marcela Sedlackova, +420 603 265 166, marcelasedlackova@seznam.cz; neuropsychiatrie@gmail.com
Jakub Hort, MD. prof. PhD.
Slovakia1 site
AuraMedica s.r.o., Neurologická ambulancia, OMNIA BUSINESS CENTER, Tomášikova 19081/28C
Bratislava, Slovakia, 821 01
About this study
Official title: 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
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.
Read the 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 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:
- Body posture improvement
- 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:
- Impact on digital biomarkers (neuro-fluid dynamics (hemodynamics, CSF) and redox state of cytochrome-c-oxidase activity using fNIRS)
- Effect on plasma biomarkers associated with neurodegeneration, inflammation and neural plasticity - GFAP, NfL and S100B and BDNF
- Cognitive (spatial memory) and functional outcomes
- Sleep patterns and quality through wearable devices and questionnaires
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment (MCI)
- Being tested
- Yoga-Based Therapeutic Device (incorporating guided breathing and movement)
- Keywords
- Mind-Body Intervention, Medical Device, CSF flow, fNIRS, Feasibility Study, Alzheimer disease
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga-Based Therapeutic Device (incorporating guided breathing and movement)Device
Also called Rhythmic Breathing and Spinal Mobilization Chair
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Yoga-Based Therapeutic Device (incorporating guided breathing and movement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks (intervention period)
Secondary outcomes (22)
Change in Heart Rate Variability During Therapy over time
HRV is measured during device-guided breathing and movement sessions using wearable sensors.
Measured: During each session across 4 weeks
Change in vertical postural alignment as measured by digital posture analysis
Posture will be quantified using photographic images captured weekly, with a standardized posture grid overlaid on each image. The grid will allow for objective measurement of spinal alignment and the sagittal vertical axis.
Measured: Baseline and 4 timepoints altogether corresponding to 4 treatment weeks
Change in spine flexibility as measured by the Thomayer test (in cm)
Spine flexibility will be assessed using the Thomayer forward bend test. Participants reach toward the floor from a standing position with knees straight, and the distance between fingertips and floor (positive or negative) will be recorded and compared pre/post.
Measured: Baseline and weekly
Change in nightly average heart rate variability (SMSSD) during sleep as measured by wearable sensors in Milliseconds (ms)
HRV will be continuously monitored using validated wearable PPG-based devices. The nightly average root mean square of successive differences (RMSSD) will be extracted and averaged weekly. Baseline-week values will be compared to Week 4 values.
Measured: Nightly, throughout the 4-week study period
Change in nightly average resting heart rate during sleep as measured by wearable sensors (in bpm)
Resting heart rate will be measured each night using wearable devices during sleep. Weekly averages will be calculated and compared from baseline to Week 4.
Measured: Nightly, throughout the 4-week study period
Change in nightly average respiratory rate (Breaths per minute) during sleep as measured by wearable sensors
Respiratory rate will be assessed via wearable sensors each night during sleep. Weekly averages will be calculated and compared between baseline and the end of the intervention.
Measured: Nightly, throughout the 4-week study period
Change in cortical hemodynamic activity (HbO and HbR concentrations) at rest and during intervention, measured by fNIRS
Hemodynamic changes will be assessed using fNIRS to measure oxygenated (HbO) and deoxygenated hemoglobin (HbR) concentrations in the prefrontal cortex.
Measured: Baseline, Week 4, and during each intervention session
Change in cortical water signal (tissue hydrodynamics) measured by H2O-specific wavelength sensor
Hydrodynamic properties of cortical tissue will be assessed using NIR absorption at water-sensitive wavelengths (e.g., ~980 nm). Water content changes will be used as a proxy for CSF bulk flow / interstitial flow.
Measured: Baseline, Week 4, and during each intervention session
Change in oxidation state of cytochrome c oxidase measured by broadband fNIRS
Redox activity of mitochondrial cytochrome c oxidase (oxCCO) will be evaluated using broadband fNIRS to assess metabolic shifts in the prefrontal cortex.
Measured: 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
Sleep architecture will be measured using photoplethysmography-based wearable devices each night. Proportions of time spent in light, deep, and REM sleep will be computed and averaged weekly.
Measured: Nightly, over the 4-week intervention period
Change in sleep quality subscale score (B-PSQI) from the GlymphActive Questionnaire
Sleep quality will be assessed using the B-PSQI subscale of the GlymphActive Questionnaire, which includes the 7 standard components of the PSQI-B. Total scores range from 0 to 21, with higher scores indicating worse sleep quality. Score (range 0-21; higher = worse sleep quality)
Measured: Baseline and Week 4
Change in spatial navigation performance (corrent responses) as measured by the Intersections Spatial Memory Cognitive Task
The Intersections Task is a 3D computerized spatial navigation test mimicking real-city routes. It assesses egocentric and allocentric spatial memory and perspective-taking. Participants are transported across intersections during the learning phase and later asked to recall correct routes.
Measured: Familiarization at screening, Baseline and Week 4
Change in global cognitive function as measured by the Mini-Mental State Examination (MMSE)
Global cognitive function will be assessed using the MMSE. This brief screening tool evaluates orientation, memory, attention, language, and visuospatial skills. Scores range from 0 to 30. Higher scores indicate better cognitive function. Score (range 0-30; higher = better cognition)
Measured: Baseline and at Week 4
Change in functional ability as measured by the Functional Activities Questionnaire (FAQ-CZ)
Functional status will be assessed using the Czech version of the FAQ-CZ, which evaluates the participant's ability to perform instrumental activities of daily living. Higher scores indicate greater functional impairment. Score (range 0-30; higher = more impairment)
Measured: Baseline and at Week 4
Change in subjective memory complaints as measured by the McNair Memory Complaint Questionnaire
Subjective memory will be evaluated using the McNair Memory Complaint Questionnaire. It assesses the frequency and severity of self-perceived memory problems in daily life. Higher scores reflect more frequent complaints. The questionnaire consists of 21 items assessing the frequency and severity of perceived memory problems in everyday life. Each item is rated on a 5-point Likert scale. Total scores range from 0 to 84, with higher scores indicating more frequent or severe memory complaints. Score (range 0-84; higher = worse subjective memory)
Measured: Baseline and Week 4
Change in anxiety symptoms as measured by the Beck Anxiety Inventory (BAI)
Anxiety symptoms will be assessed using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire designed to measure the severity of anxiety in adults. Each item is scored on a 0-3 scale, resulting in a total score range from 0 to 63. Higher scores indicate greater anxiety severity. Score (range 0-63; higher = worse anxiety)
Measured: Baseline and Week 4
Change in depressive symptoms as measured by the Geriatric Depression Scale - Short Form (GDS-15)
Depressive symptoms will be assessed using the 15-item version of the Geriatric Depression Scale (GDS-15). This self-report tool consists of yes/no questions focused on mood, motivation, and daily functioning. Total scores range from 0 to 15, with higher scores indicating greater depressive symptom severity. Score (range 0-15; higher = worse depression)
Measured: Baseline and Week 4
Change in Global QoL score as measured by the WHOQOL-BREF
Global quality of life and general health will be assessed using the first two items of the WHOQOL-BREF questionnaire. Participants rate their overall quality of life and satisfaction with health. Scores are averaged and transformed to a 0-100 scale. Higher scores indicate better perceived overall well-being and health.
Measured: Baseline and Week 4
Change in plasma neurofilament light chain (NfL) concentration
Neurofilament light chain, a biomarker of axonal damage, will be measured in plasma using ultra-sensitive SIMOA technology. Concentrations at baseline and Week 4 will be compared to assess neurodegeneration-related changes. Unit of measure: Picograms per milliliter (pg/mL)
Measured: Baseline and Week 4
Change in plasma brain-derived neurotrophic factor (BDNF) concentration
Plasma levels of BDNF will be quantified using SIMOA technology. BDNF is a neurotrophin involved in neuroplasticity and synaptic maintenance. Pre-/post-intervention levels will be compared. Unit of Measure: Nanograms per milliliter (ng/mL)
Measured: Baseline and Week 4
Change in plasma glial fibrillary acidic protein (GFAP) concentration
GFAP, a marker of astrocytic activity and gliosis, will be measured in plasma using SIMOA. Baseline and Week 4 concentrations will be compared to assess glial response to intervention. Picograms per milliliter (pg/mL) as units of measure.
Measured: Baseline and Week 4
Change in plasma S100 calcium-binding protein B (S100B) concentration
S100B, a glial-derived protein associated with neuroinflammation and blood-brain barrier dysfunction, will be measured using SIMOA. Changes between baseline and Week 4 will be analyzed. Nanograms per milliliter (ng/mL) as units of measure
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CIATRIX, INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Oulu
- Responsible party
- Sponsor
- Investigators
- Patrik Simko, MA. PhD., Study director, Masaryk University, The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC), CIATRIX Inc.Katerina Sheardova, MD. PhD., Principal investigator, The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989242
- Sponsor's protocol ID
- RG-CZSK-PH2
- Other IDs
- RG-CZSK-PH2
- Acronym
- ReGlyde
- Status last verified
- Jul 2025
- First submitted
- 6 May 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06989242
- Acronym / sponsor ID
- ReGlyde / RG-CZSK-PH2
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment (MCI)
- Keywords
- Mind-Body Intervention, Medical Device, CSF flow, fNIRS, Feasibility Study, Alzheimer disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CIATRIX, INC.Industry (pharma, biotech, devices)
- Collaborators
- University of Oulu
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- Body posture improvement
- 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:
- Impact on digital biomarkers (neuro-fluid dynamics (hemodynamics, CSF) and redox state of cytochrome-c-oxidase activity using fNIRS)
- Effect on plasma biomarkers associated with neurodegeneration, inflammation and neural plasticity - GFAP, NfL and S100B and BDNF
- Cognitive (spatial memory) and functional outcomes
- Sleep patterns and quality through wearable devices and questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm - Device-Guided Movement and Breathing | Experimental | Device: Yoga-Based Therapeutic Device (incorporating guided breathing and movement)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). |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga-Based Therapeutic Device (incorporating guided breathing and movement)Also: Rhythmic Breathing and Spinal Mobilization ChairThe 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. | Device | Intervention Arm - Device-Guided Movement and Breathing |
Primary outcome
Number and type of intervention-related adverse events as assessed by a yoga-specific adverse events questionnaire
Time frame: Throughout the 4-week intervention period
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.
Number of participants completing ≥90% of scheduled intervention sessions
Time frame: 4 weeks (intervention period)
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.
Mean percentage of completed intervention sessions per participant
Time frame: 4 weeks (intervention period)
Calculated as the average percentage of completed sessions per participant across the study population. This reflects session adherence at the group level.
Number of participants who withdraw from the study before completing intervention
Time frame: 4 weeks (intervention period)
The dropout rate will be determined by the number of participants who discontinue the study before completing all planned sessions, regardless of reason.
22 secondary outcomes
Change in Heart Rate Variability During Therapy over time
Time frame: During each session across 4 weeks
Change in vertical postural alignment as measured by digital posture analysis
Time frame: Baseline and 4 timepoints altogether corresponding to 4 treatment weeks
Change in spine flexibility as measured by the Thomayer test (in cm)
Time frame: Baseline and weekly
Change in nightly average heart rate variability (SMSSD) during sleep as measured by wearable sensors in Milliseconds (ms)
Time frame: Nightly, throughout the 4-week study period
Change in nightly average resting heart rate during sleep as measured by wearable sensors (in bpm)
Time frame: Nightly, throughout the 4-week study period
Change in nightly average respiratory rate (Breaths per minute) during sleep as measured by wearable sensors
Time frame: Nightly, throughout the 4-week study period
Change in cortical hemodynamic activity (HbO and HbR concentrations) at rest and during intervention, measured by fNIRS
Time frame: Baseline, Week 4, and during each intervention session
Change in cortical water signal (tissue hydrodynamics) measured by H2O-specific wavelength sensor
Time frame: Baseline, Week 4, and during each intervention session
Change in oxidation state of cytochrome c oxidase measured by broadband fNIRS
Time frame: 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
Time frame: Nightly, over the 4-week intervention period
Change in sleep quality subscale score (B-PSQI) from the GlymphActive Questionnaire
Time frame: Baseline and Week 4
Change in spatial navigation performance (corrent responses) as measured by the Intersections Spatial Memory Cognitive Task
Time frame: Familiarization at screening, Baseline and Week 4
Change in global cognitive function as measured by the Mini-Mental State Examination (MMSE)
Time frame: Baseline and at Week 4
Change in functional ability as measured by the Functional Activities Questionnaire (FAQ-CZ)
Time frame: Baseline and at Week 4
Change in subjective memory complaints as measured by the McNair Memory Complaint Questionnaire
Time frame: Baseline and Week 4
Change in anxiety symptoms as measured by the Beck Anxiety Inventory (BAI)
Time frame: Baseline and Week 4
Change in depressive symptoms as measured by the Geriatric Depression Scale - Short Form (GDS-15)
Time frame: Baseline and Week 4
Change in Global QoL score as measured by the WHOQOL-BREF
Time frame: Baseline and Week 4
Change in plasma neurofilament light chain (NfL) concentration
Time frame: Baseline and Week 4
Change in plasma brain-derived neurotrophic factor (BDNF) concentration
Time frame: Baseline and Week 4
Change in plasma glial fibrillary acidic protein (GFAP) concentration
Time frame: Baseline and Week 4
Change in plasma S100 calcium-binding protein B (S100B) concentration
Time frame: Baseline and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katerina Sheardova MD, PhD., MD, PhD. contact
Patrik Simko, MA. PhD. study director
Masaryk University, The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC), CIATRIX Inc.
Katerina Sheardova, MD. PhD. principal investigator
The International Clinical Research Center of St. Anne's University Hospital in Brno (FNUSA-ICRC)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga-Based Therapeutic Device (incorporating guided breathing and movement) in people with Alzheimer Disease and Mild Cognitive Impairment (MCI), run by CIATRIX, INC. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Czechia, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrik Simko PhD., MA. PhD. (+420774846288, patrik.simko@ciatrix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and type of intervention-related adverse events as assessed by a yoga-specific adverse events questionnaire (time frame: Throughout the 4-week intervention period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.