Engineering Sleep for Cognitive Performance - SBIR Topic DPA26BZ03-DV012

Funding Amount:

Est. $2,000,000

Deadline to Apply:

July 22nd, 2026

Objective:

Develop and demonstrate a wearable, non-invasive, closed-loop system that enhances the restorative functions of sleep. The system must monitor neurophysiological signals in real-time to deliver non-pharmacological stimuli that measurably improve physiological recovery and sustain cognitive performance under conditions of operational stress, such as sleep restriction.

Description:

The ability to sustain cognitive performance and accelerate physiological recovery is critical in demanding operational environments. Severe sleep restriction is known to degrade essential functions by disrupting the brain's natural restorative processes [1], including glymphatic waste clearance [2,3] and synaptic plasticity, which are tightly coupled to specific neurophysiological events during sleep [4].

PHASE I

This topic seeks the development of a wearable, closed-loop system that directly enhances the efficiency and restorative quality of sleep through precisely-timed, non-pharmacological intervention. Proposals should describe a system that integrates sensors to monitor neurophysiological signals in real-time, with the specific goal of identifying slow-wave sleep (SWS) and other key features of the sleep architecture. Upon detection of these opportune moments, the system should deliver precisely-timed, non-invasive stimuli to augment the brain's intrinsic restorative mechanisms. The primary modalities of interest for this intra-sleep intervention are auditory stimulation and/or photic stimulation. The proposed system should be able to demonstrate that the intervention measurably enhances the underlying biological processes, such as by increasing slow-wave activity or improving biomarkers associated with glymphatic clearance. Proposals that also incorporate a synergistic, pre-sleep conditioning modality (e.g., non-invasive vagus nerve stimulation) to prime the neuro-immune state are encouraged. The ultimate goal is a fieldable prototype that improves sleep efficiency and sustains cognitive function. Proposals not focused on a closed-loop, wearable system using targeted sensory stimulation to modulate sleep architecture will not be considered. Phase I fixed payable milestones for this program should include:• Month 2: A report detailing the initial system architecture, selection of hardware/software components, and the proposed biological mechanisms of action. The report must define the preliminary evaluation metrics (cognitive and physiological) and their expected relationship to cognitive resilience and operational readiness.• Month 4: A report on system integration and closed-loop algorithm performance (using simulated or pilot data). • Month 6: An interim demonstration of the working integrated proof-of-concept prototype. Must include a complete human subjects research (HSR) protocol for the Phase II study, demonstrating a study design and statistical power analysis sufficient to detect a 15% improvement in cognitive performance metrics under sleep restriction/stress compared to a sham/control group. Submission of this clinical study protocol to the local Institutional Review Board (IRB).• Month 9: Final report summarizing the Phase I approach and benchtop/usability testing results, including a detailed description of the prototype. The report must detail any additional engineering that needs to be completed (if any) in Phase II to achieve fully functional closed-loop control. Must include a detailed technical Statement of Work (SOW) for the Phase II effort.

PHASE II

This topic is soliciting both Phase I and Direct to Phase II (DP2) proposals. DP2 Feasibility Criteria: Proposers should demonstrate that the scientific and technical feasibility, equivalent to the completion of a Phase I effort, has already been established. This feasibility documentation is a prerequisite for evaluation. To be considered, proposers should provide detailed evidence of a functional, closed-loop neuromodulation prototype. This documentation should substantiate that the existing system is capable of: (1) Real-Time Monitoring: Monitoring and processing relevant physiological signals (e.g., EEG) to identify specific features of sleep architecture in real-time. (2) Closed-Loop Stimulation: Delivering targeted, non-invasive stimuli (e.g., acoustic, photic) in a closed-loop manner, triggered by the detection of specific neurophysiological events. (3) Measurable Biological Effect: Producing a quantifiable, statistically significant modulation of a desired biological process. Evidence should be provided showing that the stimulus successfully engages the target mechanism (e.g., demonstrates enhancement of slow-wave activity, alters a relevant biomarker, etc.) compared to a control condition. This evidence may include peer-reviewed publications, technical reports, patent applications, or other detailed data packages from prior work. The documentation should be sufficient for a thorough technical review and confirm that the core scientific principles have been successfully demonstrated. Phase II: Building upon the demonstrated feasibility, the objectiveof Phase II is to mature the existing prototype into an advanced, integrated system (TRL 6) suitable for rigorous testing and validation in a human study. Performers will focus on optimizing the system's design for robustness, reliability, and user comfort for multi-night use, while advancing the on-board algorithms for sleep stage classification and precise stimulus delivery. The central effort of Phase II will be to conduct a formal validation study under a relevant stressor, such as a multi-day sleep restriction protocol. This study should be designed to demonstrate a statistically significant and operationally relevant benefit compared to a sham or control condition. Primary outcome measures should include both: Cognitive Performance: Quantifiable improvement (>15%) on validated tasks measuring vigilance, processing speed, and/or executive function (e.g., Psychomotor Vigilance Task (PVT), Digit Symbol Substitution Test (DSST)). Physiological Mechanisms: Evidence of successful target engagement, such as measurable enhancements in sleep architecture (e.g., increased slow-wave activity), or changes in physiological or blood-based biomarkers associated with glymphatic clearance and/or neuroinflammation. By the end of Phase II, performers will deliver the advanced prototype(s), all associated control software/source code, user manuals, and the complete, documented results from the validation study. The final report should include a comprehensive plan for transition, addressing manufacturing readiness, production cost estimates, and reliability data. Phase II fixed milestones for this program should include: • Month 11 (Month 2 of Base): Report detailing machine learning model pre-training and hardware integration of sensors and stimulation arrays. Must provide an initial cost estimate for manufacturing scale-up. Submission of the local IRB-approved protocol to the Office of Human and Animal Research Oversight (OHARO) for secondary review.• Month 14 (Month 5 of Base): Report on validation recordings and model artifact-robustness testing against expert scoring (Cohen’s ? = 0.75 vs. expert scoring). • Month 18 (Month 9 of Base): Report detailing initial data from pilot or human-factors testing to provide an early indication that sleep is being improved. The report must explicitly address the established physiological and cognitive metrics (e.g., initial data indicating a trajectory toward the 15% enhancement in physiological recovery or restorative biomarkers compared to baseline/sham).• Month 21 (Month 12 of Base): Comprehensive Phase II Base report documenting the completed in-lab study. This report must detail the system's efficacy, specifically demonstrating whether the system successfully achieved the targeted cognitive improvement metrics (15% improvement) as measured by the Psychomotor Vigilance Task (PVT), Digit Symbol Substitution Test (DSST), and Task Switching assessments compared to the sham/control group.Phase II Option fixed milestones for this program should include: • Month 22 (Month 1 of Option): Interim report detailing the progress of the operational environment study. Must include a data quality review from the field, assessing device robustness, protocol compliance in a real-world setting, and preliminary analysis of the primary cognitive and physiological endpoints.• Month 27 (Month 6 of Option): Interim report detailing the progress of the operational environment study. Must include a data quality review from the field, assessing device robustness, protocol compliance in a real-world setting, and preliminary analysis of the primary cognitive and physiological endpoints.• Month 33 (Month 12 of Option): A comprehensive fielding guide, commercialization documentation, and a revised cost estimate for manufacturing scale-up. The Final Report must synthesize both the in-lab and operational environment data, providing definitive proof of the technology’s efficacy in real-world, high-stress conditions by demonstrating whether the system achieved improvement in the cognitive assessments compared to the sham/control group.

PHASE III DUAL USE APPLICATIONS

The successful development of this technology is expected to create a transformative, non-pharmacological tool for cognitive sustainment and physiological recovery. Phase III efforts will focus on transitioning the mature technology by securing non-SBIR funding from government partners and/or private sector investors to scale manufacturing, obtain any necessary regulatory clearances, and enter military and commercial markets. Military/DoD Applications: The system could be transitioned to programs focused on warfighter performance and resilience. Potential applications include use in pre-deployment conditioning to build resilience, during operational periods to sustain cognitive function when sleep is limited, and in post-deployment settings to accelerate recovery and support long-term brain health, potentially mitigating risks associated with TBI and neurodegenerative disease. Commercial Applications: This technology has broad commercial potential in clinical and consumer health sectors. Applications include therapeutic devices for sleep disorders, tools for mitigating the effects of shift-work in aviation and commercial transport, performance optimization tools for elite athletes, and consumer wellness devices for individuals seeking to improve their daily sleep quality and cognitive function.

Who will win?

If you can achieve the objective above better than any other company on the market, you have a very high-likelihood of success and should apply.

Who is eligible to apply?

Any company that meets the following criteria:

• For-profit company

• U.S.-owned and controlled.

• 500 or fewer employees (including affiliates)

How Can BW&CO Help?

1) End-to-end support including, strategy, writing of the full proposal, and administrative & compliance support.

2) Proposal strategy and review.

3) Administrative & compliance support.

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