SonoHeal: Smart Resonating Closed-loop Airway Clearance Device

Information

  • Research Project
  • 10011518
  • ApplicationId
    10011518
  • Core Project Number
    R43HL152912
  • Full Project Number
    1R43HL152912-01
  • Serial Number
    152912
  • FOA Number
    PA-19-272
  • Sub Project Id
  • Project Start Date
    4/1/2020 - 5 years ago
  • Project End Date
    3/31/2021 - 4 years ago
  • Program Officer Name
    LACHOWICZ-SCROGGINS, MARRAH ELIZABETH
  • Budget Start Date
    4/1/2020 - 5 years ago
  • Budget End Date
    3/31/2021 - 4 years ago
  • Fiscal Year
    2020
  • Support Year
    01
  • Suffix
  • Award Notice Date
    3/31/2020 - 5 years ago
Organizations

SonoHeal: Smart Resonating Closed-loop Airway Clearance Device

Project Summary Cystic Fibrosis is a genetic disorder that affects 30,000 patients in the USA with an average life span of 37 years and the majority (85%) of the mortality is a result of lung disease. Airway Clearance Therapies (ACT) are extensively used by patients for forceful mechanical clearance of mucus accumulated in airways using high pressure and high frequency vibrations. However, the use of ACTs is intrusive, painful, uncomfortable, and poses tremendous burden on patients who are required to perform ACTs daily for 1-2 hours. Without effective ACT, the mucus-plugged airways trap bacteria causing infections, inflammations, respiratory failures, and other complications. ACT is also used by patients with lung conditions where mucus clearance is necessary (e.g. bronchiectasis, COPD, Asthma). ACT works on the principle of vibrating the lungs to increase mucus mobility. Ideally, the therapy needs to be individualized and continuously adaptive for effective clearance. However, none of the current ACT devices and techniques, including chest physiotherapy, high-frequency chest compression, oscillation, and acoustic vibration therapies, are adaptive. The challenges with current ACT devices: 1. Brute-force approach: Patients have diverse airway geometry, mucus accretion levels, and obstruction locations. Optimal therapy requires input frequencies to match the resonant frequency of specific airways to target mucus clearance. Current ACT devices work on a set vibration pattern (Vest, oPEP, CPT) or a ?feeling- based? subjective tweaking of input frequencies and airway location (Frequencer, VibraLung), often rendering them ineffective. 2. Subjective Assessment: None of the current devices measure lung function to provide a quantitative assessment of the airway obstruction or therapy progress putting the burden on the patient to determine treatment effectiveness. 3. Poor Quality of Life: As a result, patients perform uncomfortable ACT for long durations to see a positive effect, leading to poor adherence to ACT. Further, home ACTs are considered ineffective for a large segment of the patient population due to the lack of personalized treatment. Cognita Labs?s proposed solution, SonoHeal, will be the first device to adapt the treatment in real-time based on the patient?s lung status, such that the right airways are targeted for stimulation/vibration to reduce the reliance on patient?s guesswork as well as provide effective therapy by localizing airway clearance. SonoHeal will utilize Cognita?s patent-pending airway monitoring technology that measures airway obstruction in real- time. Combined with quantified lung response with mucus localization information, SonoHeal will algorithmically tune the right resonant frequency to target patient?s airways and promote effective mucus removal. In this proposal, Cognita?s team will bring years of airway modeling, device technologies and commercialization experience to conduct in-vitro experimentation on multiple lung models to show the feasibility and efficiency of the SonoHeal device in a lab setup.

IC Name
NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
  • Activity
    R43
  • Administering IC
    HL
  • Application Type
    1
  • Direct Cost Amount
  • Indirect Cost Amount
  • Total Cost
    197130
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    838
  • Ed Inst. Type
  • Funding ICs
    NHLBI:197130\
  • Funding Mechanism
    SBIR-STTR RPGs
  • Study Section
    ZRG1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    COGNITA LABS, LLC
  • Organization Department
  • Organization DUNS
    079152829
  • Organization City
    HOUSTON
  • Organization State
    TX
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    770543945
  • Organization District
    UNITED STATES