Brain DiseasesNCT06378515
Physical Activity, Sleep and Brain Health Based on the Glymphatic System
An observational study of Brain Diseases, run by University of Valencia at 1 site in Spain.
Trial summary
This study is aiming to analyze the impact of physical activity on neurohydrodynamics and glymphatic activity on young adults. This study is designed as a multicenter descriptive observational study with information collection at two different times: before performing a short exercise routine and during its… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Diseases
- What is being tested?
- Physical activity, postural changes and cognitive tasks
- How many people
- 77 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: University students
Who may be able to join
- Students enrolled in a bachelor's degree from one of the universities participating in the study.
- Students who consent to participate in the study indicating that they have been informed of all relevant aspects of the study.
Who cannot join
- Students under the age of 18.
- Students with cognitive or sensory difficulties or with insufficient command of the language that, in the opinion of the recruiting professional, makes it difficult to understand the questions raised in the surveys, scales or instruments used in the study.
- Who are participating at the time of recruitment in a clinical trial or experimental study. Participation in observational studies will not be an exclusion criterion
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat de València
Valencia, 46010
Raquel Faubel
About this study
This study is aiming to analyze the impact of physical activity on neurohydrodynamics and glymphatic activity on young adults. This study is designed as a multicenter descriptive observational study with information collection at two different times: before performing a short exercise routine and during its performance using a wearable wireless device Glymphometer.
Read the detailed description
The glymphatic system was discovered in 2013 as a brain mechanism for the elimination of protein waste in the central nervous system. Scientific findings indicate that an abnormality in this system involves a slow accumulation of protein waste, neurological inflammation, leaks in the blood-brain barrier, and finally neuronal degeneration due to the progressive loss of neurons in the central nervous system. Brain fluid dynamics, particularly those related to cerebrospinal fluid, have been shown to play an important role in brain health and the progression of neurodegenerative diseases. The Glymphometer is a device that allows the evaluation of brain health in a novel way, as it allows the monitoring of brain fluid dynamics and could allow early detection of abnormalities in the glymphatic system. This technology makes it easy to monitor brain health and allows you to set actions for a healthier lifestyle. It also makes it possible to monitor the effectiveness of emerging therapies to avoid or reduce the risk of neurological diseases. In the long term, this could allow for more cost-effective prevention tools. This device has been used in numerous research projects and is also closely related to other projects funded by the European Commission currently underway such as Neurodegenerative Disease Research (JPND). The data generated by these wearable devices will also be useful for healthcare systems as such data can be collected in other situations such as during sleep, exercise or at work. These devices will be used both at the diagnostic level and also to monitor the impact of neurological therapies, allowing for more personalized treatments. The Glymphometer has previously been used in studies that have looked at the impact of stress on brain health. Physical activity and exercise are other lifestyle factors that have an influence on brain health, as shown by preclinical studies and recent reviews on the glymphatic system, and have been proposed as preventive therapy and treatment for dementia due to their impact on the glymphatic system. The existing literature shows that lifestyle factors such as sleep, physical activity or stress can be highly relevant to brain health, but there is not enough scientific evidence based on continuous measurements of how they affect it.
- Conditions
- Brain Diseases
- Being tested
- Physical activity, postural changes and cognitive tasks
- Keywords
- glympathic system, brain health, physical activity, neurohydrodynamics
- Medical subject headings
- Brain Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity, postural changes and cognitive tasksOther
- Measuring while patients are sitting in rest for 5 minutes.
- Supine to stand test: lying down (5 min) standing up (5 min)
- Repeated sit stand test: sitting (10 sec) ↔ standing (10 sec), changing position every 10 seconds for 5 minutes.
- Paced breathing in sitting position: letting patients breath 6 breaths/minute (0.1Hz) for 5 minutes.
- Breath hold manoeuvre in sitting position: 60s normal breathing, then 32s breath hold + 88s normal breathing repeated 3 times.
- Arithmetic stress test by giving the subject single digit addition. To give the pressure, subject needs to do as many as possible calculation within 1 minute with 1 minute break. This is repeated 3 times.
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain health
The data collected through the Glymphometer allows us to obtain the variable known as the G-index, which describes the activity of the glymphatic system. This G-index is based on 14 (patented) algorithms. The G-index ranges from 0 to 100, with higher brain health the higher the score
Brain health through the G-Index. Data collected through the Glymphometer allows us to obtain the variable known as the G-index, which describes the activity of the glymphatic system. This G-index is based on 14 (patented) algorithms and ranges from 0 to 100, with higher brain health the higher the score.
Measured: Basal, during 15 minutes
Secondary outcomes (6)
Physical activity (habitual)
Physical activity developed during the last 7 days using the short version of validated questionnaire IPAQ (International Physical Activity Questionnaire)
Measured: Basal
Sleep duration
Number of hours of sleep habitual (including naps) specifically in weekdays and weekends. Collected by indirect methods using self-reported questions.
Measured: Basal
Sleep Quality
Brief Version of the Pittsburgh Sleep Quality Index (B-PSQI)
Measured: Basal
Chronotype
Morning or night preferences collected by the short version of validated questionnaire MEQ (rMEQ)
Measured: basal
Self-reported health status
Self-reported by the participant using a specific question about their health status during the last 12 months
Measured: Basal
Other variables
Other variables of interest collected reported by the participant through an ad hoc questionnaire: height and weight, age, sex, chronic conditions diagnosed, country of residence, academic degree studied, years at university, tobacco and alcohol consumption, cohabitation (alone, in family, shared), complementary activities (hours per week dedicated to other activities outside the university in the last month such as work, Other regulated studies, volunteering, family care...
Measured: Basal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 May 2024
- Primary completionApr 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseasesStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu
- Responsible party
- Principal investigator, Raquel Faubel Cava, University of Valencia
- Investigators
- Raquel Faubel, PhD, Principal investigator, Universitat de València
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378515
- Sponsor's protocol ID
- Glymphactive
- Status last verified
- Aug 2024
- First submitted
- 17 Apr 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymous data of the participants is planned to be shared with other researchers for scientific reasons.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Sleep and Brain Health Based on the Glymphatic System
- ClinicalTrials.gov ID
- NCT06378515
- Acronym / sponsor ID
- Glymphactive
- Conditions
- Brain Diseases
- Keywords
- glympathic system, brain health, physical activity, neurohydrodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- University of Oulu
- Study start
- 1 May 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Apr 2024 (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 study is aiming to analyze the impact of physical activity on neurohydrodynamics and glymphatic activity on young adults. This study is designed as a multicenter descriptive observational study with information collection at two different times: before performing a short exercise routine and during its performance using a wearable wireless device Glymphometer.
Detailed description
The glymphatic system was discovered in 2013 as a brain mechanism for the elimination of protein waste in the central nervous system. Scientific findings indicate that an abnormality in this system involves a slow accumulation of protein waste, neurological inflammation, leaks in the blood-brain barrier, and finally neuronal degeneration due to the progressive loss of neurons in the central nervous system. Brain fluid dynamics, particularly those related to cerebrospinal fluid, have been shown to play an important role in brain health and the progression of neurodegenerative diseases. The Glymphometer is a device that allows the evaluation of brain health in a novel way, as it allows the monitoring of brain fluid dynamics and could allow early detection of abnormalities in the glymphatic system. This technology makes it easy to monitor brain health and allows you to set actions for a healthier lifestyle. It also makes it possible to monitor the effectiveness of emerging therapies to avoid or reduce the risk of neurological diseases. In the long term, this could allow for more cost-effective prevention tools. This device has been used in numerous research projects and is also closely related to other projects funded by the European Commission currently underway such as Neurodegenerative Disease Research (JPND). The data generated by these wearable devices will also be useful for healthcare systems as such data can be collected in other situations such as during sleep, exercise or at work. These devices will be used both at the diagnostic level and also to monitor the impact of neurological therapies, allowing for more personalized treatments. The Glymphometer has previously been used in studies that have looked at the impact of stress on brain health. Physical activity and exercise are other lifestyle factors that have an influence on brain health, as shown by preclinical studies and recent reviews on the glymphatic system, and have been proposed as preventive therapy and treatment for dementia due to their impact on the glymphatic system. The existing literature shows that lifestyle factors such as sleep, physical activity or stress can be highly relevant to brain health, but there is not enough scientific evidence based on continuous measurements of how they affect it.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- University students
Key inclusion criteria (2 listed)
- Students enrolled in a bachelor's degree from one of the universities participating in the study.
- Students who consent to participate in the study indicating that they have been informed of all relevant aspects of the study.
Key exclusion criteria (3 listed)
- Students under the age of 18.
- Students with cognitive or sensory difficulties or with insufficient command of the language that, in the opinion of the recruiting professional, makes it difficult to understand the questions raised in the surveys, scales or instruments used in the study.
- Who are participating at the time of recruitment in a clinical trial or experimental study. Participation in observational studies will not be an exclusion criterion
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 |
|---|---|---|
| Physical activity, postural changes and cognitive tasks1. Measuring while patients are sitting in rest for 5 minutes. 2. Supine to stand test: lying down (5 min) standing up (5 min) 3. Repeated sit stand test: sitting (10 sec) ↔ standing (10 sec), changing position every 10 seconds for 5 minutes. 4. Paced breathing in sitting position: letting patients breath 6 breaths/minute (0.1Hz) for 5 minutes. 5. Breath hold manoeuvre in sitting position: 60s normal breathing, then 32s breath hold + 88s normal breathing repeated 3 times. 6. Arithmetic stress test by giving the subject single digit addition. To give the pressure, subject needs to do as many as possible calculation within 1 minute with 1 minute break. This is repeated 3 times. | Other | – |
Primary outcome
Brain health
Time frame: Basal, during 15 minutes
The data collected through the Glymphometer allows us to obtain the variable known as the G-index, which describes the activity of the glymphatic system. This G-index is based on 14 (patented) algorithms. The G-index ranges from 0 to 100, with higher brain health the higher the score Brain health through the G-Index. Data collected through the Glymphometer allows us to obtain the variable known as the G-index, which describes the activity of the glymphatic system. This G-index is based on 14 (patented) algorithms and ranges from 0 to 100, with higher brain health the higher the score.
6 secondary outcomes
Physical activity (habitual)
Time frame: Basal
Sleep duration
Time frame: Basal
Sleep Quality
Time frame: Basal
Chronotype
Time frame: basal
Self-reported health status
Time frame: Basal
Other variables
Time frame: Basal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Yes. Anonymous data of the participants is planned to be shared with other researchers for scientific reasons.
Related trials for Brain Diseases
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
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. This study is not recruiting at the moment.
Raquel Faubel, PhD principal investigator
Universitat de València
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Diseases, run by University of Valencia at 1 site in Spain.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raquel Faubel, PhD (+34651430547, raquel.faubel@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain health (time frame: Basal, during 15 minutes). 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 13 Aug 2024.