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NCT Number: NCT07620639

Consciousness Studies and Cardiovascular Health

The objective of the study is to evaluate whether a virtual reality (VR) based intervention combining binaural beats, photic stimulation, and real-time biofeedback reduces stress and improves physiological markers compared to non-VR interventions and usual care in patients that go to cardiology clinic.

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Key information

Conditions

Blood Pressure Relaxation Virtual Reality

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 and older
  • Able to provide informed consent (English only for pilot)
  • Chronic Selective Serotonin Reuptake Inhibitors/ Serotonin-norepinephrine reuptake inhibitors (SSRI/SNRI) or Attention Deficit/ Hyperactivity Disorder (ADHD) meds allowed (recorded)
  • Normal vision and hearing
  • Stable vitals (HR 55-100 bpm, Systolic Blood Pressure (SBP) 90-160mmHg (millimeters of mercury, afebrile)
  • Willing to abstain 6 hours pre-session from caffeine, nicotine, heavy exercise
  • Willing to tolerate electroencephalogram (EEG) headband, Galvanic Skin Response (GSR) electrodes are small sensors placed on the skin (usually fingers or palm) and virtual reality (VR) headset

Exclusion criteria

  • History of seizure disorder or photosensitive epilepsy
  • Migraine with visual aura
  • Retinal disease sensitive to flicker
  • Unstable cardiac disease
  • Dysautonomia
  • Recent sedative use (benzodiazepines, opioids)
  • Beta blocker dose changes within last 7 days
  • Alcohol or recreational drugs within 12 hours
  • Active panic disorder
  • Severe motion sickness
  • Scalp conditions preventing EEG contact
  • Severe visual or hearing impairment Cognitive impairment
  • Non-English speakers (pilot in English only)

Treatment and study plan

Virtual Reality Relaxation

Behavioral

Participants will wear a virtual reality headset delivering a guided relaxation experience. The VR program includes: immersive visual environments designed to induce calmness, binaural audio beats engineered to promote relaxation, and photic (light) stimulation synchronized with audio and breath cues. The intervention is designed to support autonomic down-regulation and enhance the participant's relaxation response.

Video Meditation

Behavioral

Participants will view a guided meditation video displayed on a screen. The video includes: soothing visual imagery, gentle narration guiding breath and awareness, calming background music. This intervention is intended to facilitate psychological relaxation through traditional audiovisual meditation techniques.

Live Guided

Behavioral

Participants will receive a live, instructor-led relaxation session conducted by a trained study team member. The facilitator will guide the participant through: controlled breathing exercises, progressive muscle relaxation, calming verbal prompts, and mindfulness-based awareness techniques. The goal is to induce relaxation through direct interpersonal guidance.

Primary outcomes

  1. Change in Self-Reported Stress

    Time frame: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)

    Change in self-reported perceived stress using a validated stress assessment tool PSS-10 (Perceived Stress Scale). This scale is a widely used 10-item questionnaire that measures the degree to which situations in life are appraised as stressful over the past month. It evaluates how unpredictable, uncontrollable, and overloaded respondents find their lives over the previous month, with scores from 0-40 (higher = more stress).

Secondary outcomes

  1. Change in Heart Rate Variability (HRV)

    Time frame: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)

    Change in Heart Rate Variability (HRV) will be measured using wearable-based physiological monitoring or electrocardiogram (ECG). HRV will be quantified in milliseconds using standard HRV metrics.

  2. Change in Galvanic Skin Response (GSR)

    Time frame: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)

    Change in Galvanic Skin Response (GSR), measured in microsiemens (µS), reflecting changes in sympathetic autonomic arousal. GSR will be collected using skin-conductance sensors placed on the fingers/palm

  3. Change in Electroencephalogram (EEG)-Derived Neural Activity

    Time frame: Baseline (Day 1), mid-intervention session (Day 1), and immediately after intervention session (Day 1)

    Change in EEG spectral power measured in microvolts squared (µV²), collected using a noninvasive headband EEG sensor and analyzed using predefined spectral power metrics based on the study's EEG signal-processing protocol.

Study contacts

Contact information is provided by the study sponsor or research team.

Priscilla Valls

CONTACT

[email protected]

3052438937

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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