Evaluating a Mat-Based Biometric Vibration System for Sleep and Daily Recovery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-frequency whole-body vibration mat.
- Who it may be relevant to
- Registry conditions: Healthy Adult Male and Female Volunteers. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Physiological and Psychological Impact of Low-Frequency Vibration Therapy: A Longitudinal Randomized Clinical Trial
Overview
The goal of this randomized clinical trial is to learn whether a low-frequency "kinetic wellness" mat (a comfortable mat that gently vibrates) can improve stress recovery, sleep quality, mood, and attention in healthy adults ages 18-45. The main questions it aims to answer are: * After 3 weeks, does regular use of the vibrating mat increase heart rate variability (a noninvasive marker of the body's ability to recover from stress) and improve sleep, mood, perceived stress, and anxiety compared with no mat use? * Do patterns of resting brain activity (measured with EEG) and heart rate variability (HRV) change from before to after the program, and are those changes related to each other? Researchers will compare two groups: an Experimental group that uses the vibrating mat at home for 3 weeks, and a Control group that does not use the mat. Participants are randomly assigned to a group. Participants will: * Attend two lab visits (\~60 min) for questionnaires, resting heart activity (HRV) and brain activity (EEG), and a brief attention test. * On 3-4 days per week for 3 weeks: * Experimental group: use the vibrating mat for 15 minutes while recording HRV. * Control group: lie quietly for 15 minutes while recording HRV. * Both groups: record HRV for 15 minutes before bedtime and 15 minutes after waking on those same days. * Both groups: complete quick check-ins on feelings (after sessions and the next morning) and log caffeine/alcohol, exercise, and medications.
Interventions
- Device Low-frequency whole-body vibration mat
A noninvasive, horizontal mat that delivers low-frequency mechanical vibration (≈5-16 Hz; peak-to-peak amplitude ≤0.5 mm) while participants lie supine. The active arm uses the mat at home 15 min per session, 3-4 days/week for 3 weeks, preferably in the evening (2-3 h before bedtime). On intervention days, participants record HRV during the 15-min session and complete two additional 15-min HRV recordings (immediately before bedtime and after waking) to index short-term autonomic recovery. Brief
Primary outcome measures
- Resting EEG Spectral Power [Time frame: From enrollment to the end of treatment at 3 weeks]
- Resting EEG Directed Connectivity [Time frame: From enrollment to the end of treatment at 3 weeks]
- Resting vagally mediated HRV [Time frame: From enrollment to the end of treatment at 3 weeks]
- Longitudinal HRV Response to Intervention [Time frame: Session days across Weeks 1-3]
Secondary outcome measures (5)
- Sleep Quality (PSQI Global Score) [Time frame: From enrollment to the end of treatment at 3 weeks]
- Perceived Stress (PSQ Total Score) [Time frame: From enrollment to the end of treatment at 3 weeks]
- State Anxiety (6-Item STAI Short Form) [Time frame: From enrollment to the end of treatment at 3 weeks]
- Mood States (Brunel Mood Scale) [Time frame: From enrollment to the end of treatment at 3 weeks]
- Cognitive Test (Trail Making Test) [Time frame: From enrollment to the end of treatment at 3 weeks]
Eligibility criteria
Inclusion criteria
- Adults 18-45 years.
- Able to provide written informed consent.
- Apparently healthy and free of unstable cardiovascular, neurological, or psychiatric conditions per screening.
- Cleared for low-to-moderate intensity whole-body vibration delivered supine/recumbent on a mat.
- Willing and able to comply with study procedures: two lab visits; 3-week home protocol (3-4 days/week); three 15-min sessions; brief affect check-ins and daily logs.
- Willing to abstain from caffeine, alcohol, and strenuous exercise for 24 hours before each lab visit and to attend visits at the same time of day.
- Able to lie supine for 15 minutes and follow instructions for the HRV device.
Exclusion criteria
- Implanted electronic medical devices (e.g., pacemaker, neurostimulator).
- Uncontrolled hypertension or severe vestibular disorders.
- Current substance dependence.
- Medications known to markedly affect autonomic function or sleep architecture (e.g., beta-blockers, antiarrhythmics, sedative-hypnotics, antidepressants with strong autonomic effects).
- Diagnosed neurological or psychological disorders that substantially affect emotional processing or autonomic regulation (severe psychiatric conditions).
- Prior extensive experience with vibration therapies (to minimize expectancy bias).
- Any condition judged by study staff to contraindicate vibration exposure or preclude safe participation (including inability to tolerate supine/recumbent position).
- Unwillingness to refrain from initiating new structured exercise or relaxation programs during the study period.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Florida International University, Biscaney Bay Campus — Miami
Identifiers
NCT: NCT07221318 · IRB-25-0421