Why are we doing this research?
Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to determine if an implanted hypoglossal nerve stimulation system can be used safely in adolescents and young adults with Down Syndrome who have moderate to severe obstructive sleep apnea (OSA).
OSA occurs when the airway is blocked during sleep and causes difficulty breathing. By stimulating the hypoglossal nerve (the main nerve under the chin controlling movement of the tongue) with mild electrical stimulation, the tongue is lifted from the back of the throat. This process can help to reopen the airway in carefully selected people with sleep apnea.
This system has been approved by the United States Food and Drug Administration (FDA) for use in adults with OSA, but is considered investigational for this study because it has not been approved for adolescents, young adults, and in people with Down Syndrome.
Who can participate?
Children, teens and adults, 10 to 21 years old, who have:
- Down Syndrome
- Persistent, moderate to severe OSA
- Had prior surgery to remove both the adenoids and tonsils (called an adenotonsillectomy)
**For patients over 21 years of age, this treatment is offered as a part of the clinical care at Cincinnati Children’s.
What will happen in the study?
If you (as a participant 18 years or older) or your child qualify for this research study and you decide to participate, you will have 9 visits over a period of 12 months (1 year). Some visits will take 1 to 2 hours and others will require you/your child to spend the night at Cincinnati Children’s.
The following procedures will take place at 1 or more visits. All procedures listed are standard of care.
- Review of Medical History and Medications: review of general health, well-being and medications
- Physical Exam and Vital Signs: height and weight measurements
- Functional Tongue Exam: an exam of tongue function to determine if you/your child are likely to benefit from the device
- Questionnaires: short questionnaires about your/your child’s symptoms, how sleepy you feel in certain situations, and how well you feel in general
- Overnight Sleep Study (Polysomnography or PSG): you/your child will spend the night at Cincinnati Children’s and have sensors attached to your body to track how it responds during sleep
- Drug-induced sleep endoscopy (DISE): you/your child will have a flexible camera placed into the nose, while under sedation, which will take pictures of the nose and throat to help identify locations that may be contributing to snoring and sleep apnea
- Surgery: 3 incisions will be made in the skin while you/your child are under anesthesia and the nerve stimulator will be implanted
- Postoperative X-ray: an X-ray of the device will be performed after surgery to verify the position of the device and electrodes
- Weekly Use Questionnaires: weekly questionnaire about how often you/your child are using the device
You/your child will first have a Baseline Visit and 3 screening procedures to determine if you are likely to benefit from the device and are able to participate in this study. At the Baseline Visit and first screening, you/your child will meet with the study staff and/or the surgeon who will describe the surgery and perform various procedures. These will determine if you/your child are able to move on to the second screening.
During the second screening, you/your child will have an overnight sleep study (Polysomnography or PSG), if you have not already completed one recently. Based on the study results, the doctor will determine if you/your child are able to continue to the third screening.
At the third screening, you/your child will undergo a drug-induced sleep endoscopy (DISE). Based on the results of this test, the doctor may determine if you/your child are a candidate for nerve stimulation therapy and will schedule you for surgery.
During the surgery, 3 incisions will be made in the skin. An electrode attached to a wire will be surgically implanted around one of the hypoglossal nerves through 1 incision under the chin. A second incision just below the collar bones will be made to implant a stimulator (a small device that provides mild electrical impulses to the hypoglossal nerve) under the skin. A third incision will be made between the ribs to implant a pressure sensor. The wire attached to this sensor will also be connected to the stimulator. The 3-part system will then be tested to see if it moves the tongue. Later, after your/your child’s body has healed, the implanted system will be turned on to see if it helps to open the airway while sleeping to improve breathing. After the surgery, you/your child will stay in the hospital for 1 or more nights, based on recovery time.
You/your child will then have the following visits:
- 1 Week after Surgery: follow-up visit to make sure the wound is healing
- 1 Month after Surgery: answer questions about general well-being and symptoms, activate the device (you/your child will receive a patient programmer, a hand-held remote control, to adjust the stimulation), and spend the night for a PSG
- 1 Week after the System is Turned On: talk about what it’s like with the device, answer any questions you/your child may have, and complete a physical exam
- 2 Months, 6 Months and 12 Months after Surgery (3 visits): complete short physical exam, check on the implanted device, and spend the night for a PSG
Once the device is turned on, you/your child will be asked to fill out a weekly questionnaire about how often the device is used. You/your child will do this for the next 11 months.
After this research study has ended, you/your child will need to see the surgeon at least 1 time every year while the nerve stimulator remains implanted.
Participants, parents/guardians interested in learning more will be given a consent form that thoroughly explains all the details of the study. A member of the study staff will review the consent form with you and will be sure that all your questions are answered.
Will you/your child be paid to be in this research study?
Participants will not receive pay for their time and travel.