Summary

for people ages 18-65 (full criteria)
at San Diego, California and other locations
study started
estimated completion
Robert Owens

Description

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.

Keywords

Sleep Apnea, Obstructive Sleep Apnea Sleep Snoring Upper Airway Conditioning Snore OSA Neurostimulation Apnea Sleep Apnea Syndromes Transoral Neurostimulation Device (Snoozeal)

Eligibility

You can join if…

Open to people ages 18-65

• 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 CAN'T join 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

Locations

  • University of California San Diego
    San Diego California 92121 United States
  • Altman Clinical and Translational Research Institute
    San Diego California 92093-0990 United States

Lead Scientist

  • Robert Owens
    Associate Professor In Residence, Medicine. Authored (or co-authored) 90 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03913494
Study Type
Interventional
Last Updated