Genioglossus Muscle Training for Snoring and Obstructive Sleep Apnea



Status:Recruiting
Conditions:Insomnia Sleep Studies, Pulmonary, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 90
Updated:1/20/2019
Start Date:October 2016
End Date:September 2019
Contact:Susan Purdy, RPSGT
Email:susan.purdy@medicine.ufl.edu
Phone:352-256-5420

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Obstructive sleep apnea (OSA) carries serious health consequences for patients. Evidence
exists that some behavioral (e.g. exercise based) therapies may assist in lessening the
severity of this disorder. The proposed investigation will examine the effects of eight weeks
of genioglossus muscle strength training on measures of snoring and OSA severity as well as
genioglossus protrusive muscle strength.

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. The
genioglossus (GG, tongue) muscle plays an important role in maintaining upper airway patency.
The GG is responsible for tongue protrusion and stiffens the tongue and prevents posterior
tongue displacement and upper airway closure. The GG is a phasic respiratory muscle. One can
demonstrate inspiratory bursts in GG EMG activity slightly preceding the onset of inspiratory
activity of respiratory pump muscles. The inspiratory bursts of GG activity also increase in
response to negative pressure in the upper airway to help maintain upper airway patency. In
some OSA patients this response is blunted. While one study did not find a difference in
protrusion muscle strength between a group of OSA patients (apnea hypopnea index, AHI =
20/hour) and normal controls (Mortimore et al) there was wide variability in muscle strength
at similar AHI values. Another study (Oh et al) did find a correlation between tongue
protrusion strength and the apnea index (lower strength, higher apnea index). It is
hypothesized that strength training of the GG will reduce snoring and sleep apneas by
augmenting the resting GG tone and enhancing the ability of the muscle to respond to negative
upper airway pressure. Training of upper airway muscles including the tongue is often used in
rehabilitation of patients with prior cerebrovascular accidents or damage due to surgical
resection for cancer. Typically, the patient presses the tongue against the back of the upper
teeth (direction both upward and forward). However, it is believed that tongue protrusion is
best trained by active forward protrusion of the tongue between the teeth under load. To
facilitate GGs training participants will push a spring loaded piston forward with the
tongue. The piston fits inside an outer chamber. The piston can also be connected to a force
measuring device to estimate protrusive tongue force.

Two groups of participants will be examined: Group 1: primary snoring and Group 2: mild to
moderate OSA patients (apnea-hypopnea index < 30/hour) who are not severely obese (BMI < 40
Kg/M2) and do not have significant structural abnormalities of the upper airway or muscle
dysfunction. This preliminary investigation consists of a randomized controlled trial
(training versus sham training) with 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 training maneuvers and meet with
them weekly to observe the subject's technique and measure tongue strength. A training log
will be kept by the subjects using training schedule sheets and training will be directly
monitored at least 2 times weekly through with a study clinician (electronically via
facetime, skype or by direct observation).

Inclusion Criteria:

- Snoring + AHI < 5/hr (primary snoring group)

- AHI ≥ 5/hour and less than 30/hour (OSA group)

- Ability to understand and perform training.

- Ability to return to the UF Health 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 > 40 kg/M2

- Use of CPAP > 12 cm H2O *

- 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.

- severe daytime sleepiness (falling asleep while driving or Epworth Sleepiness Scale >
14),

- History of chronic short sleep duration (< 5 hours).
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Gainesville, Florida 32606
Phone: 352-265-5240
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