Clinical Research
At OptiRTP we are committed to rigorous clinical research and evidence generation to better understand how Optimum Bio Sound Therapy (OBST) is experienced in real-world settings and to inform future validation pathways. OBST is registered with the U.S. Food and Drug Administration as a Class I medical device and with New Zealand’s Medsafe.
Study Overview
Planned 2026 Real-World Outcomes Study
Study Design
The planned 12-week observational study will assess both subjective and objective health metrics in approximately 180 participants, using validated assessment instruments alongside continuous biometric monitoring to capture real-world patterns of use and experience.
Research Partners
Lindus Health
U.S.-based contract research organisation supporting study design and execution.
Physiological Monitoring Technology Partner
Biometric monitoring and wearable technology supporting objective data capture.
VA-Affiliated Academic Medical Center (Planned)
OptiRTP is planning clinical research activity involving a U.S. Department of Veterans Affairs–affiliated university hospital to support clinical evidence development.
Primary Assessment Areas
PROMIS Assessment Scales
- Sleep quality and disturbance
- Fatigue levels
- Pain severity and interference
- Perceived stress
- Global physical and mental health
Biometric Monitoring
- Heart Rate Variability (HRV)
- Sleep efficiency and deep sleep duration
- Resting heart rate trends
- Readiness scores and recovery metrics
- Respiratory rate and skin temperature
Healthcare Utilisation Metrics
- Changes in medication usage
- Healthcare facility utilisation trends
- Medication dependency patterns
Research Objectives
- Generate real-world evidence
- Support regulatory pathways
- Build foundation for health insurance reimbursement
