Over 50% of patients post stroke have swallowing disorders (dysphagia) placing them at risk for aspiration of medications, food and liquids into their airway. Continued aspiration is life threatening as it can frequently lead to pneumonia requiring hospital readmission. Of the estimated 300,000-600,000 new cases of dysphagia post stroke in the United States each year, however, most receive limited rehabilitation before being discharged to home or a skilled nursing facility (SNF). Those with continued risk of aspiration will receive a percutaneous endoscopic gastrostomy (PEG tube) for nutrition. Our long term goal is to develop a device and method for safe extensive daily self-training by patients in their own environment for effective rehabilitation of dysphagia post stroke. Speech pathologists will train patients and their caregivers to use the Passy Muir Swallowing Self Trainer before discharge from rehabilitation or acute care. This device provides a noninvasive vibratory stimulus to the neck with motors placed on each side of the thyroid cartilage. The vibration to the cartilage penetrates through the tissues to stimulate sensory receptors in the larynx -well known to trigger swallowing at the brain stem level. The sensory stimulation enhances practice swallows and provides automatic stimulation at regular intervals throughout the day to promote saliva swallowing. Previously, we used a laboratory version in a few chronically affected PEG tube fed patients who had failed other treatments for dysphagia. After using the device at home for daily self training, they improved their oral intake without risk-none developed aspiration pneumonia over 12 months of device use. This approach can augment or replace current approaches to rehabilitation that depend upon the patient having access to a speech pathologist for intervention only a few hours each week. The First Aim of this Phase I SBIR will identify the optimal vibratory characteristics for use with dysphagic patients by measuring their perceived urge to swallow and their frequency of swallowing as outcome measures when stimulation is adminstered for short intervals. Several different motor types, application methods, and stimulaiton durations will be tested to determine which enhance swallowing to the greatest degree. The results will be the basis for prototype development in Phase II. The Second Aim will determine the optimum time points and methods for device delivery to patients post stroke by obtaining input from speech pathologists active in dysphagia management using: 1) qualitative analyses of opinions expressed in focus groups at professional meetings of key leaders in the field; and, 2) quantitative analyses of surveys following webinars introducing the new service delivery model. Aim 2 results will be the basis for developing device training methods in Phase II. This innovative treatment device provides patients with safe swallowing self training early post stroke when many patients currently have limited opportunity to swallow because of aspiration risk. It will be highly significant in that it will enhance recovery of swallowing post stroke at reduced rehabilitation expense and increased effectiveness.
Public Health Relevance: The Passy Muir Swallowing Self Training device is an innovative approach for augmenting swallowing recovery post stroke. It will support safe and extensive patient self-training in their own environment-- a more efficient approach to rehabilitation post stroke. This innovative small business research will reduce health care costs while improving disease outcomes.
Public Health Relevance Statement: The Passy Muir Swallowing Self Training device is an innovative approach for augmenting swallowing recovery post stroke. It will support safe and extensive patient self-training in their own environment-- a more efficient approach to rehabilitation post stroke. This innovative small business research will reduce health care costs while improving disease outcomes.
NIH Spending Category: Aging; Bioengineering; Clinical Research; Dental/Oral and Craniofacial Disease; Digestive Diseases; Health Services; Patient Safety; Rehabilitation; Stroke
Project Terms: Acute; Affect; Aspiration Pneumonia; base; Brain Stem; Businesses; Caregivers; Caring; Cartilage; Characteristics; Databases; Deglutition; Deglutition Disorders; Development; Devices; dietary restriction; Discipline of Nursing; Disease Outcome; Effectiveness; Environment; Exhibits; Focus Groups; Food; Frequencies (time pattern); Gastrostomy; Goals; Health Care Costs; Home environment; Hospital Readmission; Hospitals; Hour; improved; Individual; innovation; Intake; International; Intervention; Laboratories; Larynx; Lead; Life; Liquid substance; Lung; Measures; meetings; Methods; Modeling; Motor; Neck; Neurologic; nutrition; Oral; Outcome Measure; Patient Care; Patient Education; Patients; Pattern; Persons; Pharmaceutical Preparations; Phase; Phase III Clinical Trials; Pneumonia; post stroke; Posture; Preparation; prevent; programs; prototype; Recovery; Regimen; Rehabilitation Centers; Rehabilitation therapy; Research; Risk; Saliva; Sensory; Sensory Receptors; sensory stimulus; Services; Side; Skilled Nursing Facilities; Small Business Innovation Research Grant; Solutions; Speech; Speech Pathologist; Speech Pathology; Stimulus; Stomach; stroke; Surveys; System; Testing; Thyroid cartilage structure; Time; Tissues; Training; Tube; tube feeding; United States; United States Agency for Healthcare Research and Quality; vibration
