Sleep Apnea, ObstructiveSnooZeal-snoreNCT03913494
Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring
A study testing Transoral Neurostimulation Device (Snoozeal) in people with Sleep Apnea, Obstructive and Sleep Apnea, run by University of California, San Diego at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Sleep Apnea, Sleep
- What is being tested?
- Transoral Neurostimulation Device (Snoozeal)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jul 2019to 20 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmation of snoring: must have a live-in bed partner that reports ≥ 6 months history of habitual snoring (i.e. > 5 days per week)
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Altman Clinical and Translational Research Institute
San Diego, California, 92093-0990
University of California San Diego
San Diego, California, 92121
About this study
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.
- Conditions
- Sleep Apnea, Obstructive, Sleep Apnea, Sleep, Snoring
- Being tested
- Transoral Neurostimulation Device (Snoozeal)
- Keywords
- Upper Airway Conditioning, Snoring, Snore, Sleep, OSA, Sleep Apnea, Neurostimulation
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoral Neurostimulation Device (Snoozeal)Device
Use of the Transoral Neurostimulation Device for 20 minutes, morning and night, every day for at least 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 4 Week Snoozeal Use | Experimental | 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. Receives: Device: Transoral Neurostimulation Device (Snoozeal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours
Change in percent total sleep time spent snoring
Time spent snoring divided by total sleep time as determined by Polysomnogram
Measured: 6 hours
Secondary outcomes (2)
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.
Measured: 10 minutes
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
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start30 Jul 2019
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert L. Owens, University of California, San Diego
- Investigators
- Robert Owens, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913494
- Sponsor's protocol ID
- 181359
- Acronym
- SnooZeal-snore
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2019
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25348130Camacho 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.
PubMed 29275425Deary 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.
PubMed 24888523Young 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.
PubMed 9085511Wessolleck 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.
PubMed 30595662
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring
- ClinicalTrials.gov ID
- NCT03913494
- Acronym / sponsor ID
- SnooZeal-snore / 181359
- Conditions
- Sleep Apnea, Obstructive, Sleep Apnea, Sleep, Snoring
- Keywords
- Upper Airway Conditioning, Snoring, Snore, Sleep, OSA, Sleep Apnea, Neurostimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4 Week Snoozeal Use | Experimental | Device: Transoral Neurostimulation Device (Snoozeal)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Confirmation of snoring: must have a live-in bed partner that reports ≥ 6 months history of habitual snoring (i.e. > 5 days per week)
Key exclusion criteria (17 listed)
- AHI > 15/hr
- BMI > 35
- Non-English speakers (due to necessity to complete questionnaires)
- Inability to complete daily neuromuscular stimulation
- Other sleep disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transoral Neurostimulation Device (Snoozeal)Use of the Transoral Neurostimulation Device for 20 minutes, morning and night, every day for at least 4 weeks. | Device | 4 Week Snoozeal Use |
Primary outcome
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.
Change in percent total sleep time spent snoring
Time frame: 6 hours
Time spent snoring divided by total sleep time as determined by Polysomnogram
2 secondary outcomes
Sleep Quality
Time frame: 10 minutes
Daytime Sleepiness
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Background: PubMed 25348130Camacho 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.
- Background: PubMed 29275425Camacho 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.
- Background: PubMed 24888523Deary 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.
- Background: PubMed 9085511Young 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.
- Background: PubMed 30595662Wessolleck 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Owens, MD principal investigator
UCSD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transoral Neurostimulation Device (Snoozeal) in people with Sleep Apnea, Obstructive and Sleep Apnea, run by University of California, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NREM EMGgg (time frame: 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03913494, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.