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RecruitingNCT07221318

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

Evaluating the Physiological and Psychological Impact of Low-Frequency Vibration Therapy: A Longitudinal Randomized Clinical Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Florida International University · Academic / Other
Sex
All
Age
18 Years – 45 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DEVICELow-frequency whole-body vibration matA 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.

Timeline

Start date
2025-10-06
Primary completion
2026-04-01
Completion
2026-05-01
First posted
2025-10-27
Last updated
2025-10-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07221318. Inclusion in this directory is not an endorsement.