S.I.L.E.N.C.E Snoring Treatment Clinical Trial at ChicagoENT
Current: Clinical Trial for S.I.L.E.N.C.E at 3000 N. Halsted Office
Snoring is a common disorder that affects more than 37 million people in the United States. Snoring is medically defined as the vibration of respiratory structures and the resulting sound due to obstructed air movement during breathing while sleeping. Snoring has been strongly associated with numerous health complications such as:
- High blood pressure
- Decreased mental function
- Impotence/decreased libido
- Heart attack
- Daytime drowsiness
- Increased risk of auto accident
- Irregular heartbeat
- Weight gain
In addition, snoring can also have a domino effect to the snorer’s bed partner. Yes, not only is snoring annoying and unpleasant to hear but snoring can also affect the health of the bed partner causing sleep deprivation and putting the partner at high risk for ailments mentioned above such as: high blood pressure and stroke.
New Hope Available for Snorers and Their Partners.
What is the S.I.L.E.N.C.E Snoring Clinical Trial?
The Snoring Intervention via Elevoplasty™ in a Non-surgical Clinical Environment (S.I.LE.N.C.E.) Study sponsored by Zelegent, Inc., is an in-office (3000 N. Halsted) clinical investigation of the Elevo™ Kit Snoring Intervention Device for the treatment of non-Obstructive Sleep Apnea (non-OSA) snoring. The Elevo Kit Snoring Intervention Device is an Investigational Device. CAUTION — INVESTIGATIONAL DEVICE. LIMITED BY FEDERAL (UNITED STATES) LAW TO INVESTIGATIONAL USE.
Who is Eligible to Participate in the S.I.L.E.N.C.E Study?
Applicants will undergo a comprehensive screening process prior to a determination whether or not each meets the participation criteria. Below are a few important inclusion and exclusion criteria:
- Must be over the age of 22 years
- Have a consistent bed/sleep partner willing to provide co-participant Informed Consent
- Have basic computer literacy (e.g., email) and home internet access or smartphone
- Chronic, simple snoring (bed/sleep partner-verified)
- No prior surgical treatment for snoring
- Willing and capable of providing Informed Consent
- Must not be a current cigarette smoker
- If diabetic, the diabetes must be under control by medical management
- Must not have major depression or non-controlled psychiatric illness
- Must not abuse drug or alcohol
- Must not have untreated or poorly controlled hypertension
- Cannot have a history of bleeding or clotting disorder
- No previous palatal surgery
- No known history of coronary artery disease or stroke
- Must not have significant nasal obstruction
- Must not have chronic obstructive pulmonary disease (COPD)
The enrolled participant must give written informed consent following an explanation of the risks and benefits associated with the S.I.L.E.N.C.E study.
What is the Cost to Participate in the S.I.L.E.N.C.E Study?
There is no charge for participation in the trial with the exception of standard medical care administered during an office visit.
Participants or their insurance carriers will be charged for any standard medical care received during visits. Zelegent, Inc., as the sponsor of this clinical study, will provide the Elevo Kit to the physician at no charge. There is no charge to the participant to receive the device.
The sponsor will pay the participant an honorarium of $200 upon successful completion of all follow-up requirements.
What Does the S.I.L.E.N.C.E Study Entail and How Much Time Will I Have to Spend?
This clinical trial is intended to study the safety and effectiveness of the Elevo Kit Snoring Intervention Device in the treatment of symptomatic, habitual, and disruptive snoring that is caused by flutter of tissue in the soft palate.
It is not intended for treating Obstructive Sleep Apnea (OSA). The S.I.L.E.N.C.E Study involves a minimally invasive in-office implantation of two or three identical, specially designed, absorbable sutures in the soft palate.
The patient and the patient’s bed/sleep partner will complete three (3) electronic questionnaires at specific time points during the study.
Follow up for each participant will be projected from treatment date (i.e., date of implant) to a total of the following three (3) time points:
- 30 days
- 90 days
- 180 days