Physical Activity, Sleep and Brain Health Based on the Glymphatic System

NCT ID: NCT06378515

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Physical activity, postural changes and cognitive tasks

1. 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oulu

OTHER

Sponsor Role collaborator

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Raquel Faubel Cava

Lecturer in Physiotherapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Raquel Faubel, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat de València

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitat de València

Valencia, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Raquel Faubel, PhD

Role: CONTACT

+34651430547

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Raquel Faubel

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Glymphactive

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Footwear and Brain Activity in Children
NCT07151352 ACTIVE_NOT_RECRUITING NA