We propose to develop a simple, non-invasive treatment for obstructive sleep apnea (OSA) that
uses head and neck exercises to increase oral, pharyngeal, and cervical muscle strength. OSA
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. As current therapies have
substantial limitations and are not acceptable to many patients, there is an enormous unmet
need for effective, well-tolerated, safe, and non-invasive OSA treatments. Oral, pharyngeal, and
cervical muscles dilate the upper airway and maintain airway patency during wakefulness; sleep
is associated with a decrease in neural input to muscles, leading to a decrease in muscle forces
opening the airway. Increasing the strength of these muscles can increase upper airway dilator
muscle force from the same neural input. Head and neck exercises for OSA treatment have
received attention over the past decade, with multiple placebo-controlled, randomized studies
showing improvement but incomplete resolution of OSA. Previous approaches have important
limitations. Our strategy is a simplified, effective, safe, and non-invasive head and neck exercise
program delivered with the aid of a smartphone app user interface to provide instruction and
feedback for proper exercise performance with the aid of simple devices. SleepFlex™ will
increase strength of key muscles to increase dilator muscle force during sleep. Our program
includes head and neck exercises selected to increase strength of the muscles of the tongue,
soft palate, lateral pharyngeal walls, and neck. This Phase I SBIR proposal includes program
development and performing a pilot safety and feasibility study. Aim 1: Develop smartphone
app user interface. The user interface will be a smartphone app (iOS and Android) that
incorporates instructional videos as well as other visual and written information on proper
performance of the exercises. The user interface will also include session reminders and
tracking of adherence and user feedback. Aim 2: Finalize design and manufacture exercise
devices. The exercises will each require a device that enables proper performance with
appropriate levels of resistance. Aim 3: Perform pilot safety and feasibility study. We will
enroll 10 study participants with previously-diagnosed mild to moderate obstructive sleep apnea
who have been unable to tolerate positive airway pressure therapy. All study participants will
undergo treatment for 8 weeks with the SleepFlex™ program. Adverse events (pain,
dysphagia), usability, and program acceptance and adherence will be measured.