Developing therapies for rare diseases requires a deep understanding of their complex, multi-system impact, where respiratory compromise and sleep disturbances are often critical but under-measured co-morbidities that are reported in qualitative studies as highly troublesome by patients and caregivers, with a significant impact quality of life. Clinical trials in rare diseases face immense challenges, the high patient and caregiver burden from complex in-clinic assessments like polysomnography (PSG), often makes longitudinal monitoring unfeasible, leaving a critical evidence gap. To address this gap, Sleepiz offers a clinically validated, zero-burden measurement solution for continuous real-world monitoring of sleep and respiration. The Sleepiz One+ is engineered to be completely contactless, measuring vital respiratory and sleep data from the bedside with no patient interaction, making it ideal for the most sensitive and difficult-to-monitor populations and mobility-impaired patients. The system, a CE-marked and FDA (510K) cleared medical device, delivers robust, regulatory-ready data on key parameters like breathing rate and sleep quality, providing the foundation for novel, meaningful endpoints. Pharma leaders can gain new insights into disease progression, demonstrate a therapy's holistic value on quality-of-life-related outcomes, and improve trial feasibility and patient retention. Unlocking novel endpoints to accelerate the development of life-changing therapies for rare disease communities.

 

 

Detailed Description

Summary / Rationale: Clinical development in rare diseases requires a deep understanding of complex, multi-system conditions. Sleep disturbances and respiratory compromise are often critical, yet under-measured, comorbidities that severely impact quality of life and are linked to disease progression. For therapies to demonstrate holistic value, sponsors need objective, real-world data on these vital parameters. This requires a measurement solution that places virtually zero burden on patients and their caregivers and can be easily deployed in decentralized and remote settings.

 

Unmet Need / Opportunity
The gold-standard assessments for sleep and respiratory function, such as in-clinic polysomnography (PSG), are often unfeasible for rare disease patients due to mobility limitations, cognitive impairment, or the needs of certain rare disease populations. These single-night, high-burden assessments prevent the longitudinal data collection necessary to understand disease progression and a therapy's true impact on quality of life over time. There is a critical need for a contactless, low burden, and continuous monitoring solution to make trial participation accessible and to generate meaningful, real-world endpoints.

 

Proposed Solution / Partnership
Sleepiz One+ is a next-generation digital measurement solution engineered specifically for capturing sleep and respiratory endpoints in the most sensitive patient populations. Its completely contactless nature makes it ideal for decentralized rare disease trials.

1. Zero-Burden by Design: A simple, one-time setup in the patient's home enables continuous monitoring with no patient interaction required. This is essential for maximizing adherence and minimizing caregiver stress.

2. Longitudinal Characterization: By collecting data every night, Sleepiz One+ provides insight into the natural history of a condition's impact on sleep and breathing, allowing for the detection of subtle therapeutic effects over time.

3. Validated & Regulatory-Ready: As a CE-marked and FDA (510k) cleared medical device integrated into the DEEP evidence framework, Sleepiz One+ provides robust, submission-ready data, accelerating the path to regulatory acceptance of novel endpoints.

 

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 rare diseases to collaborate in deploying Sleepiz One+ as a digital health solution for collecting meaningful clinical endpoints. Objectives include:

1. Generating novel exploratory and secondary endpoints to deeply phenotype the disease.

2. Improving trial accessibility and retention for difficult-to-recruit populations.

3. Demonstrating therapeutic benefit on meaningful quality-of-life aspects like sleep quality and respiratory stability.

 

Call to Action
Are you working to solve the challenges of a rare disease? Let’s connect to explore how zero-burden digital measures can unlock critical insights and elevate your clinical program.