Evaluating a Mat-Based Biometric Vibration System for Sleep and Daily Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorFlorida International University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Low-frequency whole-body vibration mat
DeviceA 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Active Vibration (Kinetic Wellness Mat)Experimental treatment 1 intervention
Group B: Quiet Rest ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Resting EEG Spectral Power
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.
Time frame
From enrollment to the end of treatment at 3 weeks2
Resting EEG Directed Connectivity
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.
Time frame
From enrollment to the end of treatment at 3 weeks3
Resting vagally mediated HRV
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.
Time frame
From enrollment to the end of treatment at 3 weeks4
Longitudinal HRV Response to Intervention
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.
Time frame
Session days across Weeks 1-3Secondary outcomes
1
Sleep Quality (PSQI Global Score)
Pittsburgh Sleep Quality Index (0-21). Higher scores = worse sleep quality. Outcome is change in global score; report also % with PSQI \>5 (poor sleep), if applicable.
Time frame
From enrollment to the end of treatment at 3 weeks2
Perceived Stress (PSQ Total Score)
Perceived Stress Questionnaire total (0-30). Higher scores = more perceived stress. Outcome is change in total score.
Time frame
From enrollment to the end of treatment at 3 weeks3
State Anxiety (6-Item STAI Short Form)
Six-item state anxiety scale (range 6-24). Higher scores = greater current anxiety. Outcome is change in total score.
Time frame
From enrollment to the end of treatment at 3 weeks4
Mood States (Brunel Mood Scale)
BRUMS subscales scored 0-16 each. Higher = more of the construct (Tension, Fatigue); higher Vigor = more energy. Outcomes are changes in each subscale.
Time frame
From enrollment to the end of treatment at 3 weeksOther outcomes
1
Affective Check-ins (Self-Assessment Manikin)
Valence and arousal rated 1-9 (single-item pictorial scales). Higher valence = more pleasant; higher arousal = more activated. Outcomes: pre-session levels and pre-session to morning change.
Time frame
From enrollment to the end of treatment at 3 weeks2
Adherece
Session completion rate (% of prescribed sessions), missed-session streaks, and proportion of analyzable HRV/EEG files. Descriptive stats; between-group comparisons by t-test or Wilcoxon as appropriate.
Time frame
From enrollment to the end of treatment at 3 weeksSponsors and contacts
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Source ClinicalTrials.gov