Evaluating a Mat-Based Biometric Vibration System for Sleep and Daily Recovery
Part of paid clinical trials in Miami, Florida.
- Sponsor
- Florida International University
- Study ID
- NCT07221318
- Status
- Recruiting
Conditions
- Healthy Adult Male and Female Volunteers
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 45 Years
- Healthy Volunteers
- Accepted
Interventions
- 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.
Study Details
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.
Key Dates
- Start date
- Oct 6, 2025
- Status verified
- Oct 2025
- Primary completion
- Apr 30, 2026
- Completion
- May 31, 2026
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Active Vibration (Kinetic Wellness Mat)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.
- No Intervention: Quiet Rest ControlParticipants 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.
Primary Outcome Measure
Resting EEG Spectral Power [ Time Frame: From enrollment to the end of treatment at 3 weeks ]
Central Contacts
- Marcelo Bigliassi, PhD305-919-4256
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Florida International University, Biscaney Bay Campus | Miami | Florida | 33181 | Dayanne Antonio, PhD student Dayanne Antonio, PhD student (SUB_INVESTIGATOR) Marcelo Bigliassi, PhD (PRINCIPAL_INVESTIGATOR) |
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