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Completed

NCT Number: NCT03913494

Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring

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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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Altman Clinical and Translational Research Institute, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transoral Neurostimulation Device (Snoozeal)

Device

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

Primary outcomes

  1. NREM EMGgg

    Time frame: 6 hours

    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.

  2. Change in percent total sleep time spent snoring

    Time frame: 6 hours

    Time spent snoring divided by total sleep time as determined by Polysomnogram

Secondary outcomes

  1. Sleep Quality

    Time frame: 10 minutes

    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.

  2. Daytime Sleepiness

    Time frame: 10 minutes

    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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Acronym: SnooZeal-snore

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 12, 2019
Registry last updated
Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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