Who can take part?
You may be eligible to participate if you:
Are 22 years or older;
Have been diagnosed with moderate to severe OSA; and
Have refused, or cannot tolerate, CPAP therapy.
To find out if you may be eligible to participate, click here to see if you pre-qualify.
OSA is the most common type of sleep apnea, impacting over 100 million people worldwide.1 It occurs when the muscles of your tongue and upper airway collapse during sleep. When this happens, it can become difficult to breathe, or you may even stop breathing, over and over throughout the night. This cycle causes poor sleep and reduces the amount of oxygen being supplied to your brain and other organs. Even though OSA is common, many people are untreated or undertreated which can result in other health issues. CPAP is the most common treatment for OSA, but studies show that more than 48% of patients2 do not use their CPAP regularly. If you have OSA and have refused, or cannot tolerate, CPAP therapy, the OSPREY study may be right for you. See if you pre-qualify by clicking here.
About aura6000® HGNS Therapy
Hypoglossal nerve stimulation (HGNS) Therapy was first established as an OSA treatment option in 2014. The aura6000® HGNS system does not involve the use of masks or hoses, and is less invasive than some other OSA therapies currently being used. To receive the aura6000® system, a small device, similar to a pacemaker, is implanted under your skin just below the collarbone during a short outpatient procedure. Most patients will go home the same day. The device works by sending mild pulses to the hypoglossal nerve located in the neck, just below your jaw. These pulses travel along the nerve to your tongue, providing muscle tone to help keep your airway open while you sleep.
See if you may qualify
Complete the online questions below and submit your information.
If you pass the questions and there is a research center near you, a study representative will contact you to ask additional medical questions and discuss the study.
If you are still interested and it seems that you may be eligible, your information will be sent to the research center.
The research center staff will contact you to discuss the study, answer your questions, and possibly schedule an appointment.
What happens during the study?
The OSPREY study is accepting volunteers in the US with moderate to severe sleep apnea. The study involves up to 17 visits over a 16-month period. The study is broken into 4 parts:
- Screening: Participants visit the research center to review health history and answer questions. During this time, a few sleep studies are done to make sure HGNS therapy is the right option.
- Implant: During a same-day outpatient procedure, the aura6000® HGNS device is implanted beneath the skin.
- Group Assignment: Participants are randomly assigned into one of two groups. Group 1 will have the device turned on 1-month after implant, whereas Group 2 will have the device turned on 7 months after implant.
- Follow Up: Participants visit the research center and sleep lab regularly for overnight sleep tests. These visits allow the study team to program the device and see if the implant is helping. There are also questionnaires that participants fill out to measure sleep quality.
If you are eligible for the study, the study team will contact you to give you more information so you can make an informed decision about participating. The study team will be available at every step along the way to support you and answer your questions.
If you qualify, and decide to participate, all study-related care will be given at no cost to you.
What is a clinical study?
Clinical studies explore whether a medicine, treatment, or device is safe and effective for humans. Clinical studies are scientific studies in which new medicines and treatments are tested to make sure they are safe and effective for people to take and use. They are one of the most important steps in bringing new treatments to patients.
What is HGNS Therapy?
HGNS Therapy uses a small device that is put under your skin just below your collarbone. A surgeon puts it in during a short outpatient procedure. Most people go home the same day.
How does HGNS Therapy work?
HGNS Therapy works by sending out mild pulses to the hypoglossal nerve in your neck. The device sends mild pulses which activates the muscles of the tongue and upper airway, creating muscle tone similar to when you are awake. The increased muscle tone helps to prevent the tissues of the airway from collapsing during sleep.
What are my rights as a study participant?
Choosing to take part in the OSPREY Study is up to you. You will still be able to get your usual medical care, no matter what you decide. You will get all study-related care, including the cost of the HGNS Therapy device, at no cost to you. Your privacy and confidentiality will be protected. Even if you join the study, you are free to leave at any time without giving a reason.
Why is clinical research important?
Clinical research adds to medical knowledge and helps bring new treatments to people with medical conditions. In order to make new treatments available to the public they need be studied in clinical trials. Clinical trials rely on the participation of volunteers in order to succeed. On average, it can take up to 8 years for a new treatment to reach the public, the major issue being how long it takes to complete the clinical trials (often due to shortage of participants). All new medical treatments and drugs have gone through clinical trials to make sure that they are safe and effective.
Who runs clinical studies?
Clinical studies can be sponsored, or funded, by device or pharmaceutical companies, academic medical centers, voluntary groups, or health care providers. Every clinical study site is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.
What does it mean to participate?
Taking part in a clinical study typically involves taking tests to ensure you are a match for the study. If you qualify, you will visit the clinic regularly to receive the drug or treatment. The study staff will monitor your progress and well-being. Before taking part in a study, you are informed about what it means to participate in the study, including how the study is conducted, how you are protected during the study and the risks and benefits of participating. You may choose to end your participation in the study at any time. You should learn about the risks and benefits of any clinical study before you agree to take part.
What happens if I sign up?
There are a few steps to make sure the OSPREY study is a good fit for you. Step 1: Complete the online questions and submit your information. Step 2: If you pass the questions and there is a research center near you, a study representative will contact you to ask additional medical questions and discuss the study. Step 3: If you are still interested and it seems that you may be eligible, your information will be sent to the research center. Step 4: The research center staff will contact you to discuss the study, answer your questions, and possibly schedule an appointment. Before officially joining the study, the researchers will explain the study in detail with you including the possible risks and benefits. Remember, you can choose to stop participating at any time for any reason.
1: Young et al 2008
2: Zhao et al 2017