Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring

NCT03913494 | Completed

• 1 other identifier: 181359
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Sleep Apnea, Obstructive; Sleep Apnea; Sleep; Snoring

Keywords

Upper Airway Conditioning; Snoring; Snore; Sleep; OSA; Sleep Apnea; Neurostimulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Sleep Quality

  10 minutes

• Daytime Sleepiness

  10 minutes

Study Arms (1)

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.

Device: Transoral Neurostimulation Device (Snoozeal)

Interventions

Transoral Neurostimulation Device (Snoozeal) DEVICE

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

4 Week Snoozeal Use

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmation of snoring: must have a live-in bed partner that reports ≥ 6 months history of habitual snoring (i.e. \> 5 days per week)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (2)

Altman Clinical and Translational Research Institute

San Diego, California, 92093-0990, United States

Location

University of California San Diego

San Diego, California, 92121, United States

Location

Related 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.

  PMID: 25348130 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.

  PMID: 29275425 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.

  PMID: 24888523 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.

  PMID: 9085511 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.

  PMID: 30595662 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Snoring

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Owens, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 12, 2019
• Study Start: July 30, 2019
• Primary Completion: February 20, 2020
• Study Completion: February 20, 2020
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)