Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring

University of California, San Diego48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Sleep Apnea, Obstructive Sleep Apnea Sleep Snoring

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Altman Clinical and Translational Research Institute

San Diego, California, United States

University of California San Diego

San Diego, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 hours

Change in percent total sleep time spent snoring

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

Time frame: 6 hours

Secondary Outcomes

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.

Time frame: 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