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

Florida International University (FIU) logo

Florida International University (FIU)

Status

Enrolling

Conditions

Healthy Adult Male and Female Volunteers

Treatments

Device: Low-frequency whole-body vibration mat

Study type

Interventional

Funder types

Other

Identifiers

NCT07221318
IRB-25-0421

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Active Vibration (Kinetic Wellness Mat)
Experimental group
Description:
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.
Treatment:
Device: Low-frequency whole-body vibration mat
Quiet Rest Control
No Intervention group
Description:
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.

Trial contacts and locations

1

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Central trial contact

Marcelo Bigliassi, PhD

Data sourced from clinicaltrials.gov

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