Clinical trial NCT03913494: Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring
Official title: Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Sleep Apnea
Sleep
Snoring
Keywords: Upper Airway Conditioning
Snoring
Snore
Sleep
OSA
Sleep Apnea
Neurostimulation
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: NREM EMGgg
timeFrame: 6 hours
measure: Change in percent total sleep time spent snoring
timeFrame: 6 hours
Secondary outcomes:
measure: Sleep Quality
timeFrame: 10 minutes
measure: Daytime Sleepiness
timeFrame: 10 minutes
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Altman Clinical and Translational Research Institute
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: UCSD
name: Robert Owens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Camacho M, Certal V, Abdullatif J, Zaghi S, Ruoff CM, Capasso R, Kushida CA. Myofunctional Therapy to Treat Obstructive Sleep Apnea: A Systematic Review and Meta-analysis. Sleep. 2015 May 1;38(5):669-75. doi: 10.5665/sleep.4652.
citation: Camacho M, Guilleminault C, Wei JM, Song SA, Noller MW, Reckley LK, Fernandez-Salvador C, Zaghi S. Oropharyngeal and tongue exercises (myofunctional therapy) for snoring: a systematic review and meta-analysis. Eur Arch Otorhinolaryngol. 2018 Apr;275(4):849-855. doi: 10.1007/s00405-017-4848-5. Epub 2017 Dec 23.
citation: Deary V, Ellis JG, Wilson JA, Coulter C, Barclay NL. Simple snoring: not quite so simple after all? Sleep Med Rev. 2014 Dec;18(6):453-62. doi: 10.1016/j.smrv.2014.04.006. Epub 2014 May 9.
citation: Young T, Finn L, Hla KM, Morgan B, Palta M. Snoring as part of a dose-response relationship between sleep-disordered breathing and blood pressure. Sleep. 1996 Dec;19(10 Suppl):S202-5. doi: 10.1093/sleep/19.suppl_10.s202.
citation: Wessolleck E, Bernd E, Dockter S, Lang S, Sama A, Stuck BA. Intraoral electrical muscle stimulation in the treatment of snoring. Somnologie (Berl). 2018;22(Suppl 2):47-52. doi: 10.1007/s11818-018-0179-z. Epub 2018 Sep 6.