Airway Muscle Training for Obstructive Sleep Apnea

Obstructive sleep apnea (OSA) is a common disorder characterized by intermittent narrowing or
closure of the upper airway during sleep. Loss of muscle tone with sleep onset and decreases
in ventilatory drive following the loss of the wakefulness stimuli to breathe combine to
result in upper airway closure in patients with structurally susceptible upper airways. We
hypothesize that training of upper airway muscles will improve sleep apnea by augmenting the
resting upper airway muscle tone and ability of the muscles to respond to negative
intraluminal pressure. Training with a primitive wind instrument (such as a Digeridoo) and
oral pharyngeal exercises (OPE) used in speech therapy have been shown to improve sleep
apnea. Individuals who play certain types of wind instruments appear to have a lower risk of
sleep apnea. However, to date the mechanism of improvement and the optimal method of upper
airway training have not been well defined. We recently completed a study with a facial
exerciser (Facial Flex) designed to improve facial muscle tone and found a decrease in
snoring in a group with loud snoring but minimal sleep apnea. A group of UF physiologists
(including co investigators Drs. Davenport and Silverman) have also demonstrated that brief
periods of training with high inspiratory and/or expiratory threshold loads improved cough
and swallowing in patients with impairment in upper airway function. Although respiratory
pump muscles provide the driving force for pressure generation during training with pressure
threshold loads, the upper airway muscle must maintain a patent upper airway resisting high
negative or positive intraluminal pressures. For example, the palate must maintain a seal
preventing air escape through the nose when high positive pressure is generated through a
mouthpiece. Of interest a limited number of very high intensity efforts appears to be the
optimal way to train muscles.

We propose targeting a group of mild to moderate OSA patients (apnea-hypopnea index <
30/hour) who are not severely obese (BMI < 35 Kg/M2) and do not have significant structural
abnormalities of the upper airway or muscle dysfunction. We will perform a randomized
controlled trial (training versus sham training) with 25 subjects in each treatment arm using
two months of daily training (5 out of 7 days each week). A home sleep study (including EEG)
will be performed before and following the training. The change in the apnea-hypopnea index
adjusted for sleep stage and body position will be compared. Use of home sleep studies will
dramatically reduce the cost of the study. A sleep technologist will educate subjects on
performance of maneuvers and meet with them weekly to observe the subject's technique. A
training log will be kept by the subjects using training schedule sheets and daily training
will be monitored through weekly web-based communication with a study clinician.

Inclusion Criteria:

- Age > 18 years,

- AHI ≥ 5/hour and less than 30/hour

- Ability to understand and perform training.

- Ability to return to the UFHealth Sleep Center 1X per week for the (8 week) duration
of the study.

Exclusion Criteria:

- Pregnancy

- Prior Upper airway surgery (nasal surgery is allowed)

- Severe nasal obstruction

- BMI > 35 kg/M2

- Use of potent narcotics

- History of arrhythmia (other than PACs and PVCs)

- Coronary artery disease or congestive heart failure (patients with controlled
hypertension will be included),

- Moderate to severe lung disease

- History of pneumothorax.10. severe daytime sleepiness (falling asleep while driving or

- Epworth Sleepiness Scale [Appendix 1] > 14),

- History of chronic short sleep duration (< 5 hours).