Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring (SnooZeal-snore)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03913494|
Recruitment Status : Not yet recruiting
First Posted : April 12, 2019
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive Sleep Apnea Sleep Snoring||Device: Transoral Neurostimulation Device (Snoozeal)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||May 30, 2021|
|Estimated Study Completion Date :||May 30, 2021|
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.
- 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
- 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.
- 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
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
|Contact: Pamela DeYoung, RPSGT/BSfirstname.lastname@example.org|
|Contact: Dillon Gilbertson, MSemail@example.com|
|United States, California|
|Altman Clinical and Translational Research Institute|
|San Diego, California, United States, 92093-0990|
|University of California San Diego|
|San Diego, California, United States, 92121|
|Principal Investigator:||Robert Owens, MD||UCSD|