NCT07221318 · Florida International University
Evaluating a Mat-Based Biometric Vibration System for Sleep and Daily Recovery
What this study is about
The goal of this randomly assigned 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.
View original scientific description
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 affect check-ins (valence, arousal) and logs of caffeine/alcohol, exercise, and medications are completed on those days. Pre- and post-program lab visits include questionnaires plus resting HRV and EEG. The control arm follows the identical schedule without vibration. The device provides no heat or electrical stimulation.
Primary outcome measures
Resting EEG Spectral Power
Time frame: From enrollment to the end of treatment at 3 weeks
Eyes-closed 15-minute, supine resting EEG using a 24-channel Smarting Mobi system. Preprocessing: 0.5-30 Hz band-pass, ocular SSP, ±100 µV artifact rejection, common-average reference; clean data segmented into 10-s epochs. Outcome is band power in Theta (4-8 Hz), Alpha (8-13 Hz), Beta (13-30 Hz), averaged across all electrodes and epochs (units: power; may be log-transformed for analysis). Higher values indicate stronger oscillatory activity in each band. Primary analysis compares Post-Baseline change between groups.
Resting EEG Directed Connectivity
Time frame: From enrollment to the end of treatment at 3 weeks
From the same 15-minute, eyes-closed, supine EEG. Frequency-domain Granger causality computed per 10-s epoch; spectra averaged within Theta (4-8 Hz), Alpha (8-13 Hz), Beta (13-30 Hz). Connectivity summarized across all electrodes via: (a) Global directed strength (mean of all non-diagonal influences; unitless; higher = stronger overall directed connectivity); (b) Nodal inflow and outflow (sum of incoming vs. outgoing influences for each electrode; unitless; higher = stronger received/sent influence); and (c) Pairwise directed influence (value for each electrode pair; unitless). Primary analysis compares Post-Baseline change between groups, with band-specific follow-ups.
Resting vagally mediated HRV
Time frame: From enrollment to the end of treatment at 3 weeks
Heart rate variability measured during a 15-minute, eyes-closed, supine rest in the lab. Inter-beat intervals captured with Optimal HRV; processed in Kubios (artifact correction; 4 Hz resampling; files with \>5% corrected beats excluded; spectral estimates with 300-s windows, 50% overlap). Outcomes reported as: * RMSSD (ms): Root mean square of successive differences. Higher = greater parasympathetic (vagal) activity. * HF power (0.15-0.40 Hz, ms²): High-frequency power. Higher = greater parasympathetic activity. Primary analysis compares change (Post - Baseline) between groups for each metric; an exploratory composite (mean of RMSSD and HF z-scores) may be reported to summarize parasympathetic tone.
Longitudinal HRV Response to Intervention
Time frame: Session days across Weeks 1-3
RMSSD and HF recorded (i) during the 15-min home session (vibration vs quiet rest), (ii) 15 min before bedtime, and (iii) 15 min after waking. Outcomes are trajectories and group differences over time (linear mixed-effects). Benefit onset (threshold) will be explored via segmented regression/GAM change-point. Operational definition (pre-specified exploratory): first of two consecutive session-day recordings where RMSSD exceeds each participant's Baseline median by ≥0.10 log-units (\~10% increase), sustained thereafter.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Miami, Florida
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 27, 2025 · Source of record for eligibility and locations