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

NCT ID: NCT07221318

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-06
• Study Completion Date: 2026-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Low-frequency whole-body vibration mat

Intervention Type: 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.

Quiet Rest Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Low-frequency whole-body vibration mat

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Florida International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Florida International University, Biscaney Bay Campus

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Marcelo Bigliassi, PhD

Role: CONTACT

marcelo.bigliassi@fiu.edu

305-919-4256

Facility Contacts

Marcelo Bigliassi, PhD

Role: primary

mbiglias@fiu.edu

305-348-2005

Dayanne Antonio, PhD student

Role: backup

daantoni@fiu.edu

Other Identifiers

IRB-25-0421

Identifier Type: -

Identifier Source: org_study_id