Case Study
Validating "The Light" for Sleep Quality & Autonomic Balance
Discover how Reputable's real-world evidence platform helped a cutting-edge hardware company prove their product's impact on the nervous system, sleep quality, and overall well-being.
Statistically Significant Outcomes
Increase in HRV
A significant improvement in Heart Rate Variability (p=0.019), a key indicator of nervous system recovery and readiness.
Lower Resting Heart Rate
A significant reduction in lowest heart rate during sleep (p=0.031), suggesting improved cardiovascular rest.
Less Need for Sleep Aids
Participants reported a 93% reduction in their need for sleep-related medications after using The Light.
Broad Sleep Improvements
Participants reported improvements across all 14 domains of the PSQI sleep survey, from fewer bad dreams to better daytime function.
The Challenge: Quantifying the Impact of a Novel Light Device
An innovative hardware company developed "The Light," a unique device designed to improve sleep and support the body's natural circadian rhythm. To gain credibility and drive adoption, they needed to move beyond design and theory to scientifically prove its physiological effects.
The client partnered with Reputable to find data-driven answers to their key questions:
- **Nervous System Impact:** Can we objectively measure if The Light improves autonomic nervous system function, a core component of rest and recovery?
- **Subjective Experience:** Do users actually *feel* a difference? Does their self-reported sleep quality, and daytime function improve?
- **Primary Benefits:** What are the strongest, most defensible claims we can make to consumers and potential investors?
- **Future Research:** What do these initial findings tell us about where to focus our next, larger-scale study?
Our Solution: A Full-Service, Decentralized Clinical Trial
Reputable designed and executed a 14-day pilot study to generate the preliminary real-world evidence needed. Our platform provided an end-to-end solution, managing the entire research process with scientific rigor.
Methodology Deep Dive
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Phase 1: Onboarding & Baseline
20 participants were recruited and onboarded. Each received a wearable sensor (Oura Ring) to capture objective biometric data and completed a baseline Pittsburgh Sleep Quality Index (PSQI) survey.
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Phase 2: Intervention & Data Capture
For 14 days, participants used The Light in their homes. Our platform passively collected 24/7 biometric data, including sleep stages, HRV, and heart rate.
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Phase 3: Final Analysis & Reporting
Our data scientists analyzed the objective and subjective data, delivering a final report that identified statistically significant findings and provided clear strategic recommendations.
The Results & Business Impact
The pilot study successfully uncovered statistically significant improvements in key biomarkers, providing powerful, evidence-based support for the product's core concept.
"The significant improvements in...autonomic regulation, as defined by HRV and HR metrics, found in the present pilot study exposes a potential avenue for future research."
— Reputable Final Report
Key Business Outcomes:
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Scientifically Validated Claims: The company can now make defensible claims that The Light "supports autonomic balance" and "improves cardiovascular rest," backed by significant HRV and HR data.
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Clear Marketing & R&D Focus: The data provided a clear signal to focus marketing and future research on the device's impact on the nervous system, emotional regulation, and overall well-being.
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Enhanced Consumer Trust: By pairing objective data (improved HRV) with subjective feedback (better sleep, less need for meds), the company can build a powerful and trustworthy narrative.
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Foundation for a Larger Study: The promising results from this pilot provide the confidence and rationale needed to invest in a larger, more robust trial.
Data Highlights from the Final Report
This pilot study produced compelling objective and subjective data, painting a clear picture of The Light's benefits.
Study Demographics
Participant Gender
- 64% Women
- 36% Men
Study Completion
Completion Rate
Objective Biomarker Data (Wearable Sensor)
| Biomarker Metric | % Change | p-value |
|---|---|---|
| Heart Rate Variability (HRV) | +6.79% | 0.019 |
| Lowest Heart Rate | -3.04% | 0.031 |
| Average Heart Rate | -2.45% | 0.063 |
*A p-value < 0.05 is statistically significant.
Subjective Sleep Quality (PSQI Survey)
| Area of Improvement | % Change (Improvement) |
|---|---|
| Need for Sleep Medication | -92.63% |
| Trouble Sleeping due to Bad Dreams | -89.23% |
| Trouble Staying Awake During Day | -87.27% |
*Based on participant self-reported outcomes.
The Reputable Advantage
We don't just provide data; we deliver clarity and confidence. Our platform is built to de-risk product development and empower brands with undeniable proof.
Full-Service Research Partner
We manage everything from study design and recruitment to data analysis and reporting, acting as an extension of your team.
High-Fidelity Real-World Data
We combine objective, 24/7 biometric data with validated subjective surveys for a complete, multi-layered view of product performance.
Regulatory Confidence
Our platform and methodologies are designed to generate compliance-ready data, ensuring your claims are supported by thorough, defensible evidence.
Ready to prove your product's efficacy?
Let's build the evidence you need to lead the market. Schedule a free strategy session with our research experts to discuss your goals and how we can help you achieve them.
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