Sleep Medicine Clinical Trials

A doctor in a white coat sits at a desk, holding a pen and taking notes on a clipboard. A patient sits across the table. A stethoscope rests on the desk next to an open laptop, suggesting a consultation or medical discussion.

Every year, dozens of new medications, diagnostic tools, and therapeutic devices are invented to help people get better sleep. Sleep Practitioners is proud to help the researchers who develop these products test them with carefully constructed, safe clinical trials.

Sleep Practitioners is one of only a handful of sleep clinics in the Southeast that participate in clinical trials for sleep medicine. Our founder, Dr. Charles Wells, and Dr. Charles Smith are co-principal investigators in FDA-sanctioned trials for new:

Medications

Diagnostic Devices

Therapeutic Devices

In more than 30 years of research on new diagnostic tools and treatments in sleep medicine, Sleep Practitioners has participated in almost 100 clinical trials. We’ve tested treatments for every sleep condition and are commonly selected by pharmaceutical companies and other research entities due to the high quality of our trial results. In fact, every treatment currently on the market for restless legs syndrome went through at least one phase of testing at Sleep Practitioners.

We are also actively engaged in testing new medical devices. Sleep Practitioners participated in trials that led to the approval of the Inspire implantable device, which has helped thousands of sleep apnea sufferers get better sleep.

What Is a Clinical Trial?

Clinical trials are part of the new drug or new device approval process set out by the US Food and Drug Administration. The approval process is designed to help safeguard patients against ineffective or potentially harmful treatments. New medications and devices must undergo several phases of testing before they can be brought to market.

Phase I trials are designed to test the safety of a medication or device. Paid volunteers who are not afflicted with the condition that the treatment is designed for take the medication or use the device and report any ill effects or complications.
Phase II trials are limited tests of a medication’s or device’s effectiveness. During Phase II, physicians who treat the condition(s) that the treatment is designed to address identify patients who may be helped by the treatment and have few, if any, other medical conditions. In this phase, the outcomes for patients using the new treatment are compared to outcomes for patients who are taking an existing treatment or a placebo.
Phase III trials are the broadest tests of effectiveness in real-world conditions. Physicians select a much wider sample of patients for these tests, and outcomes are compared against outcomes with existing treatments or placebos.
Phase IV trials are unique in that they take place after a drug or device has been brought to market and involve detailed reporting of any side effects or complications that patients experience from using the drug in its final commercial form.

How Can I Participate in a Clinical Trial?

You can view information about all of our ongoing clinical trials on our News page. If you think one of the trials might be helpful for you in your quest for better sleep, call to ask for details, or – if you’re already a Sleep Practitioners patient – ask one of our staff members during your next appointment.

If one of our doctors thinks you might be a good fit for an ongoing or upcoming trial, they may reach out or talk to you during your next appointment.

Regardless of how you find out about it, participating in a clinical trial is 100% your decision. You’ll be given detailed information about the trial, including its possible risks and outcomes, and will be required to provide what’s known as “informed consent” before you can participate.

Why Should I Participate in a Clinical Trial?

You may wish to participate in a clinical trial with the Sleep Practitioners team for two reasons: to help with your sleep issues and to help others find relief.

How Can a Clinical Trial Help Me Get
Better Sleep?

While there is absolutely no guarantee that the treatment offered by a new drug or medical device will provide you with better sleep, many patients have found better outcomes with trial treatments than they would have with options already on the market. If you’re recommended for a clinical trial, it means that you have the condition the treatment is designed to address and that your symptoms or specific pathology are in line with the treatment’s indicated uses.

If your participation in a clinical trial does lead to better sleep, you may be permitted to continue taking that medication or using that device after the trial is concluded. Through a process called Open Label Extension, pharmaceutical companies and the FDA will sometimes allow trial participants to continue using the treatment during the interim period between the conclusion of the trial and the treatment’s formal approval.

How Can a Clinical Trial Help Others Get
Better Sleep?

There is no assurance that participating in a clinical trial will provide you with any therapeutic benefit. However, if you choose to participate, you can be confident that your participation will help others who suffer from the same or a similar condition.

Regardless of your trial results, every participant in a particular study provides invaluable data on a treatment’s strengths, weaknesses, general effectiveness, and safety. A common saying in scientific communities is “a negative result is still a result,” and that’s exceptionally true of clinical studies. Through your participation, you will be helping to advance the science of sleep medicine, an advance that will help others find better rest.

Are Clinical Trials Safe?

Clinical trials are very safe. Before the start of Phase I testing, the drug or device has already undergone significant testing with animals and other laboratory research to ensure its safety.

During a clinical trial, the patients taking the drug or using the device are monitored particularly closely by their physician. Any side effects or complications that arise are immediately addressed. If there is ever any doubt as to the safety of the treatment, the patient’s participation in the trial or the trial itself is stopped.

If I am Chosen for a Clinical Trial, am I Guaranteed to Receive a New
Treatment?

No. Not all participants in a clinical trial receive the medication or device being tested. The study has two groups: the test group and the control group.

The test group receives the treatment being tested.
The control group receives an alternative – either an existing, already-approved treatment with known results or an inactive placebo that contains no therapeutic ingredients.

The outcomes of the two groups will be compared at the end of the study. If the test group’s outcomes are statistically better than those of the control group, then the test is seen to have upheld the hypothesis that the new treatment works.

If your condition is hazardous, life-threatening, or likely to progress to something more serious, you’ll never be given a placebo by itself. No physician will ever recommend you for a clinical trial in which you are not being treated for a condition that could have long-term negative impacts on your life. If you do have such a condition and are accepted into a clinical trial as a control participant, you will be given an existing, effective treatment and not a placebo.

Advancing the Science of Sleep Medicine