Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring
Completed · Not applicable
Conditions studied: Sleep Apnea, Obstructive, Sleep Apnea, Sleep, Snoring
In brief
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.
Key facts
- Study ID
- NCT03913494
- Run by
- University of California, San Diego
- People needed
- 48
- Starts
- 2019-07-30
- Expected to finish
- 2020-02-20
- Last updated by the study team
- 2021-04-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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
- Psychiatric disorders (other than depression or anxiety)
- Snoring less than 20% of total sleep time during baseline polysomnography
Where it is running
- Altman Clinical and Translational Research Institute — San Diego, California, United States
- University of California San Diego — San Diego, California, United States
Full record on ClinicalTrials.gov
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