A clinical trial, also called a research study, is a research program that tests the effectiveness and safety of various interventions in people with sleep disorders. Clinical trials are meant to find new and improved methods of evaluating or treating a condition. They also can test new ways to help prevent diseases.
Such trials can involve risks, and there is no guarantee regarding a trials outcome. Clinical trials are conducted in phases and may span several weeks to several years.
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Clinical trials for sleep disorders are generally divided into four phases:
Phase I clinical trials involve giving a new treatment to a small number of participants. The researchers determine the best way to give the new treatment and how much of it can be given safely. Some phase I trials have a limited number of participants who would not be helped by other known treatments. Other phase I trials are performed in healthy volunteers to determine the safety of a particular treatment.
Phase II clinical trials focus on learning whether the new treatment has an effect on a specific condition. Additional information regarding the side effects of the treatment is also obtained. A small number of people are included because of the risks and unknowns involved.
Phase III clinical trials compare the new treatment with a placebo or a standard treatment for the sleep disorder. In this phase, researchers determine which study group has fewer side effects and is showing the most improvement.
Phase IV clinical trials, also called post-marketing studies, are conducted after a sleep disorder treatment has been approved. The purpose of these trials is to provide an opportunity to learn more details about the treatment and to address questions that may have come up during other phases of trials.
Sleep Disorders Study Participation
Clinical trial participants are assigned at random (a process similar to flipping a coin) to either the new treatment (treatment group) or the current standard treatment (control group) for their sleep disorder.
Randomization helps to avoid bias (having the study's results affected by human choices or other factors not related to the treatments being tested). When no standard treatment exists for a particular sleep disorder, some studies compare a new treatment with a placebo (a look-alike pill/infusion that contains no active drug). All participants are made aware that they could receive a placebo instead of the active drug.