Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring

Sleep Clinical Trial

— SnooZeal-snore  

Official title:

Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913494
• Other study ID #: 181359
• Status: Completed
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: February 20, 2020

Study information

• Verified date: April 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Snoring

Intervention

Device:
• Transoral Neurostimulation Device (Snoozeal)
Use of the Transoral Neurostimulation Device for 20 minutes, morning and night, every day for at least 4 weeks.

Locations

Country	Name	City	State
United States	Altman Clinical and Translational Research Institute	San Diego	California
United States	University of California San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in percent total sleep time spent snoring	Time spent snoring divided by total sleep time as determined by Polysomnogram	6 hours
Secondary	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
Secondary	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