Clinical Research Studies

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Before new medications and treatments are made available to the public, they must first undergo extensive testing. Clinical research includes scientific studies aimed at finding better ways to treat disease and illness using carefully selected volunteer participants. Dedicated to providing the most innovative and advanced treatments available, the team of specialists at Sleep Disorders Centers of the Mid-Atlantic in Glen Burnie, Maryland, participate in clinical research and regularly recruit participants. To learn more about the clinical research studies available, call the office. 410 582-9300, extension 113.

Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research can be described as a clinical trial or clinical study.

A clinical trial/study is an experiment designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments. Clinical trials are done to determine whether new drugs or treatments are safe and effective. There are many developmental phases of a clinical trial.

Before any clinical trials begin, researchers must first conduct lab and animal testing of the drug, procedure, or intervention to test the effectiveness, as well as safety. This is called pre-clinical phase. The FDA determines if the researchers can advance their research to human clinical trials based on the results of the lab testing. 

Clinical trials go through four phases to test safety, effectiveness, side effects, and dosage (for medication clinical trials). If researchers find a treatment safe and effective at phase III of the clinical trials, the FDA approves the treatment. Phase IV clinical trials are conducted after approval and focus on continued monitoring of the treatment for safety and effectiveness. 

• Phase I - Ensures that the treatment is safe in humans and to determine how and where it  distributes within the body.
• Phase II - Determines the right dosage and effectiveness in treating that particular disease.
• Phase III - Determines whether the treatment* would be safe and effective for a wide variety of people.
• Phase IV - Monitors public safety and potential serious adverse events. Often known as post marketing research.

Sleep Disorders Centers of the Mid-Atlantic conducts’ clinical trials out of our Glen Burnie office. Each study has specific criteria that determines your eligibility for participation. Below is a list of trials previously conducted and are being conducted at SDCMA. If you are interested or want to know more, please contact:

Tanya Alexander, CCRC our research coordinator at 410 582-9300 extension 113.

Sponsor : Apnimed

Protocol: MARIPOSA (AP-005)

Phase: 2

Title: Phase 2 Randomized Double-Blind, Placebo-Controlled, Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of Atomoxetine/Aroxybutynin (AD109) and Atomoxetine/Trazodone (AD504) to Atomoxetine Alone or Placebo in Obstructive Sleep Apnea

Mariposa Prescreening Questionnaire

Sponsor: Imbrium Therapeutics L.P.

Protocol: OAG2002

Phase 2

Title: A Phase 2, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of V117957 in Subjects with an Alcohol Use Disorder who are Experiencing Insomnia Associated with Alcohol Cessation.

Sponsor: Indorsia

Protocol: ID-078A303/DORA

Phase: 2

Title: Multi-Center, Double-Blind, Parallel-Group, Randomized, Placebo-Controlled, Three Doses, 40 Week Extension to Studies ID-078A301 and 078A302 to Assess the Long-Term Safety and Tolerability of ACT-541468 in Adult and Elderly Subjects with Insomnia Disorder