We propose to develop a system for natural sleep endoscopy (NSE) - the direct visualexamination of the pharynx during natural sleep - to define the anatomical pattern of obstructionfor individual patients and guide treatment selection in obstructive sleep apnea (OSA). OSA is adisorder of repeated upper airway obstruction during sleep that is associated with substantialcardiovascular morbidity and mortality, endocrine disturbances, daytime somnolence,decreased quality of life, and motor vehicle crashes. About 25-40% of OSA patients cannottolerate first-line treatment (positive airway pressure) and may consider other options. Oralappliances, surgery, and hypoglossal nerve stimulation offer substantial benefit for selectedpatients, albeit with associated risks, expense. Outcomes are often unpredictable but areassociated with an individual patient's pattern of airway obstruction. Current approaches ofdetermining pattern of obstruction have important limitations related to validity, feasibility, andcost. NSE is the most likely gold standard, but it has been limited to small studies in theresearch laboratory or hospital without widespread use, for multiple reasons: trained personnelrequired, lack of appropriate video recording equipment, substantial cost, and arousal whenmoving the endoscope to visualize the two major regions of the pharynx. Drug-induced sleependoscopy incorporates unconscious sedation, avoiding the latter issue but adding risks ofadministering sedation and validity concerns because unconscious sedation is not natural sleep.Our strategy for meeting this challenge is an endoscopic system for NSE: two camerasincorporated into an endoscopic catheter, microphone, accelerometer (head position), and theembedded system to record the audiovisual and position data in a patient-worn systemmounting device. This Phase I SBIR proposal includes developing the endoscopic system andperforming a limited evaluation of safety and feasibility. Aim 1: Design and manufacture dualcamera endoscopic catheter. The catheter will incorporate two existing cameras with anintegrated lens, light source, and sheath. The catheter will provide signal output to a patient-worn system mounting device for data capture during sleep. Aim 2: Design and manufacturepatient-worn system mounting device. The head-worn system mounting device will include amicrophone, accelerometer, power source, and data recording capability. Aim 3: Perform pilotsafety and feasibility study. We will enroll 10 study participants with mild to moderate OSAwho will undergo polysomnography and simultaneous evaluation with the NSE system. Adverseevents (epistaxis, pain), usability, and acceptance will be measured. Efficacy will be examined.
Public Health Relevance Statement: The proposed research is relevant to public health because obstructive sleep apnea is a
disorder of repeated upper airway obstruction during sleep that is associated with substantial
cardiovascular morbidity and mortality, endocrine disturbances, daytime somnolence,
decreased quality of life, and motor vehicle crashes and because many patients do not tolerate
first-line therapy (positive airway pressure). Outcomes of alternative treatments (oral appliances,
surgery, and hypoglossal nerve stimulation) are associated with the anatomical pattern of
obstruction. We propose to develop a system for natural sleep endoscopy - the direct visual
examination of the pharynx during natural sleep - as the likely gold standard for defining the
anatomical pattern of obstruction and guiding selection of alternative treatments in obstructive
sleep apnea.
Project Terms: airway obstruction ; airflow limitation ; airflow obstruction ; airway limitation ; obstructed airflow ; obstructed airway ; Anatomy ; Anatomic ; Anatomic Sites ; Anatomic structures ; Anatomical Sciences ; Arousal ; Cardiovascular system ; Cardiovascular ; Cardiovascular Body System ; Cardiovascular Organ System ; Heart Vascular ; circulatory system ; Clinical Trials ; Disease ; Disorder ; Drowsiness ; Somnolence ; sleepiness ; Pharmaceutical Preparations ; Drugs ; Medication ; Pharmaceutic Preparations ; drug/agent ; Endoscopes ; Endoscopy ; endoscopic imaging ; Epistaxis ; Nasal Hemorrhage ; Nose Bleed ; Nosebleed ; Equipment ; Feasibility Studies ; Patient Care ; Patient Care Delivery ; Gold ; Head ; Healthcare Systems ; Health Care Systems ; Hospitals ; Hypoglossal nerve structure ; Cranial Nerve XII ; Hypoglossal Nerve ; Twelfth Cranial Nerve ; Laboratory Research ; Light ; Photoradiation ; Magnetic Resonance Imaging ; MR Imaging ; MR Tomography ; MRI ; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance ; NMR Imaging ; NMR Tomography ; Nuclear Magnetic Resonance Imaging ; Zeugmatography ; Methods ; Morbidity - disease rate ; Morbidity ; mortality ; Movement ; body movement ; Persons ; Obstruction ; Operating Rooms ; Pain ; Painful ; Soft Palate ; Velum Palatinum ; Patients ; Pharyngeal structure ; Pharynx ; Throat ; Physical Examination ; Medical Inspection ; Physicians ; Power Sources ; Power Supplies ; pressure ; Public Health ; Quality of life ; QOL ; Research ; Risk ; Signal Transduction ; Cell Communication and Signaling ; Cell Signaling ; Intracellular Communication and Signaling ; Signal Transduction Systems ; Signaling ; biological signal transduction ; Sleep ; Testing ; X-Ray Computed Tomography ; CAT scan ; CT X Ray ; CT Xray ; CT imaging ; CT scan ; Computed Tomography ; Tomodensitometry ; X-Ray CAT Scan ; X-Ray Computerized Tomography ; Xray CAT scan ; Xray Computed Tomography ; Xray computerized tomography ; catscan ; computed axial tomography ; computer tomography ; computerized axial tomography ; computerized tomography ; Unconscious State ; Unconscious ; Unconsciousness ; consciousness loss ; United States ; Video Recording ; Videorecording ; video recording system ; Wakefulness ; Measures ; Treatment outcome ; Catheters ; Selection for Treatments ; therapy selection ; Polysomnography ; Sleep Monitoring ; Somnography ; polysomnographic ; sleep measurement ; sleep polysomnography ; base ; improved ; Clinical ; Phase ; Physiological ; Physiologic ; Evaluation ; Training ; Visual ; Individual ; Logistics ; data quality ; Measurement ; sedation ; Sedation procedure ; Oral ; Source ; Pattern ; Techniques ; System ; Syndrome, Sleep Apnea, Obstructive ; Obstructive Sleep Apnea ; Endocrine ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; meetings ; Performance ; Participant ; Devices ; Manpower ; personnel ; Human Resources ; Position ; Positioning Attribute ; Adverse Experience ; Adverse event ; Diameter ; Caliber ; Preparedness ; Readiness ; Data ; Enrollment ; enroll ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Monitor ; Development ; developmental ; safety study ; Output ; cost ; design ; designing ; Outcome ; Vehicle crash ; Automobile collision ; Automobile crash ; Car collision ; Car crash ; Motor vehicle collision ; Motor vehicle crash ; Vehicular collision ; Vehicular crash ; traffic collision ; traffic crash ; usability ; commercialization ; lens ; lenses ; alternative treatment ; Secure ; screening ; Accelerometer ; accelerometry ; activity monitor ; activity tracker ; individual patient ; Radiation exposure ; safety and feasibility ; manufacturability ; microphone ; Visualization ;
