Evaluating a Mat-Based Biometric Vibration System for Sleep and Daily Recovery

NCT07221318 | Recruiting

• 1 other identifier: IRB-25-0421
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adult Male and Female Volunteers

Keywords

whole-body vibration therapy; sleep quality; affect; mood; relaxation therapy

Outcome Measures

Primary Outcomes (4)

• 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: * 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.

  From enrollment to the end of treatment at 3 weeks

• 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

Secondary Outcomes (5)

• Sleep Quality (PSQI Global Score)

  From enrollment to the end of treatment at 3 weeks

• Perceived Stress (PSQ Total Score)

  From enrollment to the end of treatment at 3 weeks

• State Anxiety (6-Item STAI Short Form)

  From enrollment to the end of treatment at 3 weeks

• Mood States (Brunel Mood Scale)

  From enrollment to the end of treatment at 3 weeks

• Cognitive Test (Trail Making Test)

  From enrollment to the end of treatment at 3 weeks

Other Outcomes (2)

• Affective Check-ins (Self-Assessment Manikin)

  From enrollment to the end of treatment at 3 weeks

• Adherece

  From enrollment to the end of treatment at 3 weeks

Study Arms (2)

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.

Device: Low-frequency whole-body vibration mat

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.

Interventions

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.

Active Vibration (Kinetic Wellness Mat)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University, Biscaney Bay Campus

Miami, Florida, 33181, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Marcelo Bigliassi, PhD

CONTACT

305-919-4256; marcelo.bigliassi@fiu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: October 27, 2025
• Study Start: October 6, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)