Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring (SnooZeal-snore)

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive; Snoring; Sleep; Sleep Apnea
• Intervention / Treatment: Device: Transoral Neurostimulation Device (Snoozeal)

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093-0990
      • Altman Clinical and Translational Research Institute
    • San Diego, California, United States, 92121
      • University of California San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4 Week Snoozeal Use; 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); Use of the Transoral Neurostimulation Device for 20 minutes, morning and night, every day for at least 4 weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Robert Owens, MD, UCSD

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): February 20, 2020
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 12, 2019

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: OSA; Sleep Apnea; Sleep; Snoring; Neurostimulation; Upper Airway Conditioning; Snore
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Respiratory Sounds; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Snoring
• Other Study ID Numbers: 181359

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No