Research

Faculty and staff at the Sleep, Mood, Anxiety Research and Treatment Divion (SMART) conduct numerous IRB-approved studies focused on better understanding the development and treatment of sleep and anxiety disorders. If you are interested in participating in or learning more about any of the ongoing studies below please contact Rick Simmons at simmr@musc.edu or 843-792-7439.

Ongoing Studies

SEGUE Narcolepsy Transition Study

A Phase 4 Multicenter, Open-label, Single-arm Study of Safety, Tolerability, Effectiveness and Treatment Optimization in Participants Switching From Xyrem to XYWAV for the Treatment of Narcolepsy

• The study is designed to look at the usefulness and safety of switching patients from Xyrem to XYWAV in the treatment of narcolepsy. Narcolepsy is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. Participants will be male or female subjects 18 to 80 years old. The study treatment period from screening to follow-up will last approximately 17 weeks.

SYMPHONY Study

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of AXS-12 in the Treatment of Cataplexy and Excessive Daytime Sleepiness in Subjects with Narcolepsy 

• The study is designed to look at the usefulness and safety of AXS-12 or placebo for the treatment of narcolepsy with cataplexy. The open-label treatment period is 24 weeks, followed by a double-blind treatment period of 4 weeks, for a total of up to 28 weeks with 13 visits. Narcolepsy is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. The study staff nor the participants will know if they are receiving a study drug or placebo. Participants will be male or female subjects 15-75 years old with a diagnosis of narcolepsy. 

Sudden Sleep Study

A Phase 2, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 2 mg and 4 mg SUVN-G3031 Compared to Placebo in Patients

• The study is designed to look at the usefulness and safety of SUVN-G3031 or placebo for the treatment of excessive daytime sleepiness with narcolepsy. The study staff nor the participants will know if they are receiving a study drug or placebo. Participants will be male or female subjects 18-50 years old with a diagnosis of narcolepsy. The study will last approximately 3 to 7 weeks with five visits. 

Federally Funded Projects

Modeling and Modulating Mechanisms of Escape, Avoidance, and Approach in the Anxiety Disorder Spectrum   

• TK23MH123931-01A1, PI: Sege
• The purpose of this study is to test effects of repetitive transcranial magnetic stimulation on exaggerated escape and avoidance dispositions in anxiety treatment-seeking individuals, and to train Dr. Sege in neuromodulation for research and clinical purposes.

Web-Based Provider Training for Cognitive Behavioral Therapy of Nightmares (CBT-N)

• W8IXWH2110576, PI: Pruiksma
• The purpose of this study is to develop a sophisticated, user-friendly Web-based provider training course for the non-pharmacological treatment CBTN (CBTNweb), which is fully sustainable, accessible with minimal cost (financial and time) to the clinician, and results in knowledge gains similar to those of an in-person training 

Completed Studies

Targeting Disordered Escape, Avoidance and Approach Coping in the Psychology Clinic 

• MUSC Department of Psychiatry & Behavioral Sciences Chairman’s Research Development Fund Project, PI: Sege
• To identify measurable neurophysiological indicators of disordered escape, avoidance, and approach coping dispositions in individuals with clinical anxiety or related concerns, toward supporting development of neuromodulation-based clinical interventions that directly target these indicators.

Web-Based Provider Training for Cognitive Behavioral Therapy of Insomnia (CBT-I) | www.CBTIweb.org

• W8IXWH170165, PI: Taylor
• To develop a sophisticated, user-friendly Web-based provider training course for the non-pharmacological treatment CBTI (CBTIweb), which is fully sustainable, accessible with minimal cost to the clinician, and results in knowledge gains similar to those of an in-person training.