search
Back to results

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

Primary Purpose

Sleep Apnea, Obstructive, Sleep Apnea, Sleep

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transoral Neurostimulation Device (Snoozeal)
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sleep Apnea, Obstructive focused on measuring Upper Airway Conditioning, Snoring, Snore, Sleep, OSA, Sleep Apnea, Neurostimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Altman Clinical and Translational Research Institute
  • University of California San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

4 Week Snoozeal Use

Arm Description

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.

Outcomes

Primary Outcome Measures

NREM EMGgg
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
Time spent snoring divided by total sleep time as determined by Polysomnogram

Secondary Outcome Measures

Sleep Quality
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
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

Full Information

First Posted
April 10, 2019
Last Updated
April 5, 2021
Sponsor
University of California, San Diego
search

1. Study Identification

Unique Protocol Identification Number
NCT03913494
Brief Title
Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring
Acronym
SnooZeal-snore
Official Title
Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
February 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Sleep Apnea, Sleep, Snoring
Keywords
Upper Airway Conditioning, Snoring, Snore, Sleep, OSA, Sleep Apnea, Neurostimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4 Week Snoozeal Use
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transoral Neurostimulation Device (Snoozeal)
Intervention Description
Use of the Transoral Neurostimulation Device for 20 minutes, morning and night, every day for at least 4 weeks.
Primary Outcome Measure Information:
Title
NREM EMGgg
Description
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.
Time Frame
6 hours
Title
Change in percent total sleep time spent snoring
Description
Time spent snoring divided by total sleep time as determined by Polysomnogram
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Sleep Quality
Description
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.
Time Frame
10 minutes
Title
Daytime Sleepiness
Description
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
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Owens, MD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altman Clinical and Translational Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92093-0990
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25348130
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.
Results Reference
background
PubMed Identifier
29275425
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.
Results Reference
background
PubMed Identifier
24888523
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.
Results Reference
background
PubMed Identifier
9085511
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.
Results Reference
background
PubMed Identifier
30595662
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.
Results Reference
background

Learn more about this trial

Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring

We'll reach out to this number within 24 hrs