Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring

Study Overview
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Brief Summary
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Sleep Disordered Breathing (SDB) is a spectrum of conditions spanning from Simple Snoring to Severe Sleep apnea. SDB has multiple underlying mechanisms. Some portion of patients have issues with upper airway dilator muscle control; and such patients may be amenable to upper airway muscle training exercises using neuromuscular stimulation techniques. The investigators and others have published on the topic of neuromyopathy in the upper airway, defining a subgroup of OSA patients who may be amenable to training exercises. Based on this background, the investigators seek to test the hypothesis that upper airway tongue muscle training using transoral surface neuromuscular electrical stimulation may have benefits to patients with Simple Snoring.

Official Title
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Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring

Conditions
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Sleep Apnea, Obstructive, Sleep Apnea, Sleep, Snoring

Intervention / Treatment
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* Device: Transoral Neurostimulation Device (Snoozeal)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Confirmation of snoring: must have a live-in bed partner that reports ≥ 6 months history of habitual snoring (i.e. > 5 days per week) Exclusion Criteria: AHI > 15/hr BMI > 35 Non-English speakers (due to necessity to complete questionnaires) Inability to complete daily neuromuscular stimulation Other sleep disorders Tongue or lip piercing Pacemaker of implanted medical electrical devices Current or recent (within last 6 months) treatment for snoring or sleep apnea Previous oral or pharyngeal surgery other than dental Craniofacial skeletal or muscular abnormalities History of driving or other accidents due to sleepiness or an Epworth score (ESS)> 18 Pregnant Cardiac (other than hypertension), pulmonary, renal, neurologic, neuromuscular or hepatic disease Medications with sedative or myorelaxant properties or effects on cardiac or pulmonary function Substantial alcohol (>3oz/day) or use of illicit drugs Psychiatric disorders (other than depression or anxiety) Snoring less than 20% of total sleep time during baseline polysomnography

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4 Week Snoozeal Use<br>Participants will take the device home and be required to use it for 20 minutes morning and night every day for at least 4 weeks. The SnooZeal records usage time to allow assessment of compliance. | Device: Transoral Neurostimulation Device (Snoozeal)<br>* Use of the Transoral Neurostimulation Device for 20 minutes, morning and night, every day for at least 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NREM EMGgg | Genioglossal muscle activity as measured by two 25 gauge needles each containing a Teflon-coated stainless steel recording wire (<0.1 mm in diameter with  1 mm at the tip bared of Teflon and bent to form a small hook) placed perorally 1.5-2 cm into the body of the genioglossus muscle. | 6 hours | 
| Change in percent total sleep time spent snoring | Time spent snoring divided by total sleep time as determined by Polysomnogram | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | A self-report questionnaire, titled the Pittsburgh Quality of Sleep Questionnaire (PSQI), asking several questions to determine quality of sleep over the past 1 month that will be scored and added together on a scale of 0-21. | 10 minutes | 
| Daytime Sleepiness | A self-report questionnaire, titled the Epworth Sleepiness Scale (ESS), asking subjects to rate their probability of falling asleep during different situations on a scale of 0-3. Scores are added together to determine how sleepy the subject feels during the day on a scale of 0-24 | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Upper Airway Conditioning, Snoring, Snore, Sleep, OSA, Sleep Apnea, Neurostimulation