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

Sponsor

University of California, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT03913494

Collaborator

(none)

Enrollment

Locations

Arm

6.7

Actual Duration (Months)

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive Sleep Apnea Sleep Snoring	Device: Transoral Neurostimulation Device (Snoozeal)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring

Actual Study Start Date :

Jul 30, 2019

Actual Primary Completion Date :

Feb 20, 2020

Actual Study Completion Date :

Feb 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 4 Week Snoozeal Use 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.	Device: Transoral Neurostimulation Device (Snoozeal) Use of the Transoral Neurostimulation Device for 20 minutes, morning and night, every day for at least 4 weeks.

Arm

Intervention/Treatment

Experimental: 4 Week Snoozeal Use

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.

Device: Transoral Neurostimulation Device (Snoozeal)

Use of the Transoral Neurostimulation Device for 20 minutes, morning and night, every day for at least 4 weeks.

Outcome Measures

Primary Outcome Measures

NREM EMGgg [6 hours]
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.
Change in percent total sleep time spent snoring [6 hours]
Time spent snoring divided by total sleep time as determined by Polysomnogram

Secondary Outcome Measures

Sleep Quality [10 minutes]
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.
Daytime Sleepiness [10 minutes]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altman Clinical and Translational Research Institute	San Diego	California	United States	92093-0990
2	University of California San Diego	San Diego	California	United States	92121