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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 Week Snoozeal Use | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transoral Neurostimulation Device (Snoozeal) | Device | Use of the Transoral Neurostimulation Device for 20 minutes, morning and night, every day for at least 4 weeks. |
|
| 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 |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Owens, MD | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altman Clinical and Translational Research Institute | San Diego | California | 92093-0990 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25348130 | Background | Camacho M, Certal V, Abdullatif J, Zaghi S, Ruoff CM, Capasso R, Kushida CA. Myofunctional Therapy to Treat Obstructive Sleep Apnea: A Systematic Review and Meta-analysis. Sleep. 2015 May 1;38(5):669-75. doi: 10.5665/sleep.4652. | |
| 29275425 | Background | Camacho M, Guilleminault C, Wei JM, Song SA, Noller MW, Reckley LK, Fernandez-Salvador C, Zaghi S. Oropharyngeal and tongue exercises (myofunctional therapy) for snoring: a systematic review and meta-analysis. Eur Arch Otorhinolaryngol. 2018 Apr;275(4):849-855. doi: 10.1007/s00405-017-4848-5. Epub 2017 Dec 23. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D012913 | Snoring |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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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 |
| University of California San Diego |
| San Diego |
| California |
| 92121 |
| United States |
| 24888523 | Background | Deary V, Ellis JG, Wilson JA, Coulter C, Barclay NL. Simple snoring: not quite so simple after all? Sleep Med Rev. 2014 Dec;18(6):453-62. doi: 10.1016/j.smrv.2014.04.006. Epub 2014 May 9. |
| 9085511 | Background | Young T, Finn L, Hla KM, Morgan B, Palta M. Snoring as part of a dose-response relationship between sleep-disordered breathing and blood pressure. Sleep. 1996 Dec;19(10 Suppl):S202-5. doi: 10.1093/sleep/19.suppl_10.s202. |
| 30595662 | Background | Wessolleck E, Bernd E, Dockter S, Lang S, Sama A, Stuck BA. Intraoral electrical muscle stimulation in the treatment of snoring. Somnologie (Berl). 2018;22(Suppl 2):47-52. doi: 10.1007/s11818-018-0179-z. Epub 2018 Sep 6. |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |