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

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ClinicalTrials.gov Identifier: NCT03913494
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Robert L. Owens, University of California, San Diego

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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring
Actual Study Start Date : July 30, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Snoring

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.




Primary Outcome Measures :
  1. NREM EMGgg [ Time Frame: 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.

  2. Change in percent total sleep time spent snoring [ Time Frame: 6 hours ]
    Time spent snoring divided by total sleep time as determined by Polysomnogram


Secondary Outcome Measures :
  1. Sleep Quality [ Time Frame: 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.

  2. Daytime Sleepiness [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913494


Contacts
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Contact: Pamela DeYoung, RPSGT/BS 8582462183 pdeyoung@ucsd.edu
Contact: Dillon Gilbertson, MS 8582462155 dcgilbertson@ucsd.edu

Locations
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United States, California
Altman Clinical and Translational Research Institute Recruiting
San Diego, California, United States, 92093-0990
Contact: Pam Deyoung    858-246-2183      
University of California San Diego Recruiting
San Diego, California, United States, 92121
Contact: Robert Owens, MD    858-657-5258      
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Robert Owens, MD UCSD

Publications:
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Responsible Party: Robert L. Owens, Associate Physician, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03913494     History of Changes
Other Study ID Numbers: 181359
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert L. Owens, University of California, San Diego:
Upper Airway Conditioning
Snoring
Snore
Sleep
OSA
Sleep Apnea
Neurostimulation
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Snoring
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds