Following the precedent set by successful GLP-1 trials in Obstructive Sleep Apnea (OSA), expansion of drug labels into this highly prevalent and impactful condition is the new frontier for metabolic drug development. To support the differentiation of your asset, the Sleepiz One+ is engineered to effortlessly measure continuous sleep data at home and thereby replacing cumbersome and complex logistics of traditional home sleep tests and in-clinic assessments. The system, which is CE-marked for OSA diagnosis in the EU and FDA 510(k) cleared as a vital signs monitor, delivers robust, regulatory-ready data, showing an exceptional 0.94 correlation with gold-standard PSG and 98% specificity in identifying patients without significant disease. Pharmaceutical leaders can benefit from faster label expansions and reduced development costs by integrating Sleepiz into clinical development programs and providing an operationally superior solution with a high level of patient acceptance. Unlocking the significant clinical and commercial value of an OSA indication.

 

Detailed Description

Summary / Rationale: The recent SURMOUNT-OSA trial has transformed metabolic medicine, showing that innovative obesity treatments can deliver significant benefits for patients with Obstructive Sleep Apnea (OSA), a common but often undiagnosed comorbidity. As new weight loss therapies emerge, there is an urgent need for robust, patient-friendly digital measurement solutions that support the collection of high-quality primary, secondary and exploratory endpoint data on OSA in clinical trials.

 

Unmet Need / Opportunity
Current OSA endpoints are derived from in-clinic PSG measurements, which are complex, costly and burdensome for patients. Furthermore there is within-patient variability in sleep apnea that cannot be assessed with just one or two nights of in clinic PSG assessment. Low burden and continuous monitoring at home address these limitations and supports the longitudinal monitoring of sleep in the patients natural environment.

 

Proposed Solution / Partnership
Sleepiz One+ is a next-generation, patient-centric digital measurement solution, validated against gold-standard polysomnography (PSG), specifically engineered for capturing OSA-related endpoints in clinical trials. Key features include:

1. Validated Accuracy: Correlation of rₚ = 0.94 with PSG-derived AHI; sensitivity 88%, specificity 98%.

2. Patient friendly Design: Maximise compliance and ease of use through a simple one-time installation at home and completely touchless monitoring. This contactless nature allows participants to continuously maintain the most natural sleep environment at home with the “set it and forget it” technology

3. Continuous and longitudinal: Enables assessment of OSA severity and therapeutic impact by capturing night-to-night variability at home.

4. Regulatory Pathway: EU-certified for OSA diagnosis; US certification for vital signs monitoring with expansion to HSAT use underway.

 

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 novel weigh loss therapies to collaborate in deploying Sleepiz One+ as a digital measure for collecting primary, secondary and exploratory OSA endpoints in clinical trials.

 

Objectives include
Generating robust endpoint data to support regulatory filings and label expansion.

1. Improving trial efficiency and participant retention through streamlined digital workflows.

2. Demonstrating the full therapeutic value of metabolic interventions in OSA populations.

 

Call to Action
Interested in advancing digital endpoints for OSA in metabolic trials?
Let’s connect to discuss joint projects, validation studies, or integration into your upcoming clinical programs.