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

University of California San Diego

Status: Completed

Conditions: Snoring; Sleep Apnea, Obstructive; Sleep Apnea; Sleep

Treatments: Device: Transoral Neurostimulation Device (Snoozeal)

Study type: Interventional

Funder types: Other

Identifiers

NCT03913494

181359

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

4 Week Snoozeal Use

Experimental group

Description:

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.

Treatment:

Device: Transoral Neurostimulation Device (Snoozeal)