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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Vibration (Kinetic Wellness Mat) | Experimental | Participants use a low-frequency kinetic wellness mat at home 3-4 days/week for 3 weeks. Each day includes a 15-minute supine session on the active mat while recording heart rate variability (HRV), plus 15-minute HRV recordings before bedtime and after waking on those same days. After each session and the next morning, participants complete brief affect check-ins (Self-Assessment Manikin: valence, arousal) and log caffeine/alcohol, exercise, and medications. All participants attend pre- and post-intervention lab visits for questionnaires, resting HRV/EEG, and a brief cognitive test (Trail Making Test). Open-label; schedule matched to control. |
|
| Quiet Rest Control | No Intervention | Participants complete quiet supine rest at home 3-4 days/week for 3 weeks. Each day includes a 15-minute rest period without vibration while recording HRV, plus 15-minute HRV recordings before bedtime and after waking on those same days. After each session and the next morning, participants complete brief affect check-ins (Self-Assessment Manikin: valence, arousal) and log caffeine/alcohol, exercise, and medications. All participants attend pre- and post-intervention lab visits for questionnaires, resting HRV/EEG, and a brief cognitive test (Trail Making Test). Open-label; schedule matched to the experimental arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-frequency whole-body vibration mat | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 3 weeks |
| 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. | From enrollment to the end of treatment at 3 weeks |
| 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:
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. | From enrollment to the end of treatment at 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 3 weeks |
| Perceived Stress (PSQ Total Score) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 3 weeks |
| Adherece |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcelo Bigliassi, PhD | Contact | 305-919-4256 | marcelo.bigliassi@fiu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida International University, Biscaney Bay Campus | Recruiting | Miami | Florida | 33181 | United States |
We will not share individual participant data (IPD). The dataset includes high-dimensional EEG/HRV signals and time-stamped behavioral logs from a small cohort, which pose a meaningful re-identification risk even after standard de-identification. The IRB-approved consent permits use by the study team only and does not include broad data sharing. In addition, device parameter files may contain proprietary information. We will share aggregate results and analysis specifications in publications and supplements, but not raw IPD.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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|
| 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. | Session days across Weeks 1-3 |
Perceived Stress Questionnaire total (0-30). Higher scores = more perceived stress. Outcome is change in total score. |
| From enrollment to the end of treatment at 3 weeks |
| 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. | From enrollment to the end of treatment at 3 weeks |
| 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. | From enrollment to the end of treatment at 3 weeks |
| Cognitive Test (Trail Making Test) | Trail Making Test Part A and Part B completion times (seconds) nd error counts for each part. Errors include sequencing mistakes. Lower times and fewer errors indicate better performance. Primary metric: Change in TMT-B completion time and B-A (set-shifting cost) from Baseline to Post between groups, considering the amount of errors. | From enrollment to the end of treatment at 3 weeks |
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. |
| From enrollment to the end of treatment at 3 weeks |
| D001523 |
| Mental Disorders |