Digital Measure Collaboration: Sleepiz One+ for Sleep & Respiratory Endpoints in Rare Disease Clinical Trials

Chronic respiratory diseases like COPD, asthma, and IPF are 24-hour conditions, yet clinical trials often rely solely on daytime measurements, leaving a critical evidence gap. Pharmaceutical leaders can leverage this evidence gap to demonstrate their drug's superior efficacy profile, detecting exacerbations, quantifying improvements in sleep quality, demonstrate treatment effects and strengthen regulatory submissions with objective evidence of nocturnal symptom control, thereby unlocking the full value of respiratory therapies. Nocturnal respiratory symptoms and sleep disruption are typically assessed using subjective patient diaries, limiting the ability to prove round-the-clock therapeutic benefit. To bridge this gap, Sleepiz provides a validated, patient-centric solution for the continuous and objective monitoring of respiratory health and sleep quality at home. The Sleepiz One+ is a contactless device that measures key respiratory parameters and sleep quality from the bedside, collecting longitudinal, real-world data without disrupting the patient's natural sleep. As a CE mark and FDA 510(k) cleared medical device, the system delivers robust, regulatory-ready data, enabling the generation of novel endpoints related to 24-hour disease control.

Summary / Rationale:

Conditions like COPD, asthma, and IPF are 24-hour diseases, yet their assessment in clinical trials often relies on daytime, in-clinic measurements (e.g., FEV1). This approach misses a critical piece of the puzzle: nocturnal symptoms. Nighttime cough, wheezing, and sleep disruptions due to dyspnea significantly impact patient outcomes and quality of life. To demonstrate superior, round-the-clock efficacy, innovative respiratory therapies require objective, real-world data on nocturnal disease control.

Unmet Need / Opportunity:

Currently, the assessment of nighttime respiratory symptoms relies on subjective patient diaries, which can be unreliable and burdensome. Objective, in-clinic sleep studies are costly, disruptive, and fail to represent a typical night's sleep. This creates a major evidence gap. Sponsors need a scalable, reliable, and patient-friendly way to quantify a therapy's impact on nocturnal breathing patterns and sleep quality in the patient's natural environment.

Proposed Solution / Partnership:

Sleepiz One+ is a medical-grade, contactless solution designed to continuously monitor respiratory patterns and sleep at home, making it the ideal tool for generating novel endpoints in respiratory trials.

1. Objective Nocturnal Data: Moves beyond subjective reports by directly measuring breathing rate, sleep-disordered breathing events, and sleep fragmentation, providing powerful, objective evidence of a therapy's 24-hour efficacy.
2. Real-World Evidence: By monitoring patients in their own homes for extended periods, Sleepiz One+ captures the real-world impact of a treatment on nighttime symptoms, free from the artificial effects of a sleep lab.
3. Validated & Regulatory-Ready: As a CE mark and FDA 510(k) cleared medical device integrated into the DEEP evidence framework, Sleepiz One+ provides a streamlined pathway for incorporating novel nocturnal endpoints into regulatory submissions to strengthen label claims.

DEEP Integration:

Sleepiz One+ has now been fully onboarded into the DEEP structured evidence model. This integration means that all supporting validation data, technical documentation, and regulatory evidence for Sleepiz One+ are organized within DEEP’s standardized framework, further streamlining the solution’s adoption as a digital measure. As a result, partners benefit from accelerated alignment with regulatory requirements, simplified evidence review, and seamless integration into both measurement strategies and regulatory submissions.

Collaboration Goals:

We invite partners developing therapies for COPD, asthma, IPF, and other respiratory conditions to collaborate on:

1. Generating robust endpoint data on nocturnal symptom control and sleep quality improvement.
2. Demonstrating a differentiated 24-hour efficacy profile for your therapy.
3. Strengthening regulatory submissions and label claims with objective, real-world evidence.

Is your respiratory therapy providing 24-hour relief? Let’s connect to discuss how we can help you objectively measure and prove it. Contact us here.