Project Grant R43HL160368

NOVEL MYOFUNCTIONAL THERAPY WATER BOTTLE TO REDUCE OBSTRUCTIVE SLEEP APNEA AND SNORING - PROJECT SUMMARY: THERE IS A CLEAR UNMET NEED TO PROVIDE ALTERNATIVE, FIRST-LINE SOLUTIONS FOR BOTH OBSTRUCTIVE SLEEP APNEA (OSA) AND PRIMARY SNORING. MOST PEOPLE SUFFERING FROM OSA ARE CURRENTLY NOT RECEIVING TREATMENT WITH ESTIMATES OF 80% UNDIAGNOSED (23 MILLION AMERICANS) AND 40% NON-ADHERENCE TO THE GOLD STANDARD TREATMENT, CONTINUOUS POSITIVE AIR PRESSURE AMONG DIAGNOSED PATIENTS. THIS HAS SERIOUS IMPLICATIONS FOR OVERALL HEALTH RESULTING IN INCREASED DAYTIME SLEEPINESS AND COMORBIDITIES OF HYPERTENSION, HEART DISEASE, DIABETES, AND DEPRESSION. THE UNDIAGNOSED POPULATION ALONE CONTRIBUTES TO AN ESTIMATED COST BURDEN OF $30 BILLION FROM COMORBIDITIES AND MENTAL HEALTH, $26.2 BILLION FROM MOTOR VEHICLE ACCIDENTS, $6.5 BILLION FROM WORKPLACE ACCIDENTS, AND $86.9 BILLION FROM LOST PRODUCTIVITY, WITH A TOTAL COST BURDEN TO THE US OF $149.6 BILLION PER YEAR [1]. ALTHOUGH MOST PEOPLE ARE UNDIAGNOSED, INDICATORS SUCH AS SNORING CAN BE FOUND IN UP TO 94% OF OSA PATIENTS [2] AND HABITUAL SNORERS (SNORING = 3 NIGHTS/WEEK) WITH BED PARTNERS OFTEN SEEK TREATMENT FOR THEIR SNORING. LOW RISK, LOW BURDEN, AND AFFORDABLE SOLUTIONS THAT CAN BE EASILY ADMINISTERED TO OSA PATIENTS AND PRIMARY SNORERS OPEN NEW TREATMENT PARADIGMS TO REDUCE THE RISK OF OSA AND SNORING. OROPHARYNGEAL EXERCISES ARE A PROMISING THERAPY FOR MOTIVATED PATIENTS AND HAVE SHOWN, ON AVERAGE, TO REDUCE APNEA HYPOPNEA INDEX (AHI) BY 14.3 POINTS AND SNORING BY MORE THAN 50% [3,4]. DESPITE THEIR EFFICACY, A MAJOR OBSTACLE TO PATIENT ADOPTION AND ADHERENCE EXISTS THAT DEMANDS DELIVERY OF THERAPY IN LESS BURDENSOME WAYS. IN THIS SBIR PHASE I PROJECT, REMASTERED SLEEP WILL CHARACTERIZE, DEVELOP, AND CLINICALLY TEST A SIMPLIFIED MYOFUNCTIONAL THERAPY NOZZLE AND REUSABLE WATER BOTTLE TO IMPROVE ADOPTION AND ADHERENCE OF OROPHARYNGEAL EXERCISES. THE SIMPLIFIED EXERCISE REGIMEN AND CONNECTION OF THE THERAPY WITH THE BIOLOGICALLY DRIVEN ACTION OF DRINKING WATER GREATLY REDUCES DAILY THERAPY BURDEN, WHICH WILL LEAD TO IMPROVED PATIENT ADHERENCE AND ADOPTION. THE SPECIFIC AIMS ARE: AIM 1: CHARACTERIZE, DEVELOP, AND TEST PRE-PRODUCTION DEVICES. KEY THERAPY DESIGN FEATURES OF THE MYOFUNCTIONAL THERAPY NOZZLE WILL BE CHARACTERIZED. THE DEVICE WILL BE DEVELOPED AND TESTED TO WELL-DEFINED SPECIFICATIONS. THE PREPRODUCTION MODELS WILL USE PRODUCTION GRADE SILICONE MATERIALS TO MEET PRE-ESTABLISHED DESIGN AND SAFETY REQUIREMENTS. AIM 2: CONDUCT FEASIBILITY STUDY IN HUMAN SUBJECTS. A RANDOMIZED, NON-SIGNIFICANT RISK DEVICE STUDY WILL BE CONDUCTED TO ASSESS ADHERENCE AND QUALITY OF LIFE AFTER TWO MONTHS USE OF THE MT NOZZLE WATER BOTTLE VS. CONTROL FOR MILD TO MODERATE OSA PATIENTS. SECONDARY OUTCOME MEASURES WILL COMPARE CHANGES IN MYOFUNCTIONAL ASSESSMENT, AHI, OXYGEN SATURATION (SPO2), AND SNORING INTENSITY/PERCENTAGE. PHASE I WILL DE-RISK THE THERAPY AND DEVICE AND PROVIDE INPUT FOR A FUTURE PHASE II PROPOSAL THAT WILL FOCUS ON FURTHER OPTIMIZATION OF THE THERAPY AND CONDUCTING A LARGER MORE INCLUSIVE CLINICAL STUDY WITH EMPHASIS ON EFFICACY OF THE DEVICE IN TREATMENT OF SNORING AND MILD-MODERATE OSA. THIS PROPOSED WORK HAS THE POTENTIAL TO CREATE A NEW THERAPY PLATFORM FOR PATIENTS TO EASILY IMPROVE THEIR OSA AND SNORING.