Sleep Disorders
“Our clinics serve our clients' needs for specialized procedures and complex sleep studies in highly targeted populations.”
~ Stephen Thein, PhD, Pacific Research Network
5
ERG sites with PSG equipment
and sleep centers
2
affiliate sleep centers
250
sleep disorder studies
At least 40 million Americans suffer from chronic, long-term sleep disorders each year, and an additional 20 million experience occasional sleeping problems. ERG's specialized sleep labs and expert staff are dedicated to partnering in both early- and late-phase sleep trials to advance new therapeutics to market. ERG also works with clients who are assessing sleep disturbance as a secondary outcome measure in psychiatric and neurological disorders. Examples include sleep disturbance in schizophrenia, wakefulness in patients with mild to moderate Alzheimer’s disease, and insomnia related to major depressive disorder. ERG is uniquely positioned to conduct these complex inpatient trials given the flexibility of the facilities, the customized PSG bedrooms, and the extensive training of both the technicians and the clinical/medical teams.
Demonstrated Expertise in Key Indications
- Chronic Fatigue Syndrome
- Circadian Rhythm Disorders
- Delayed Sleep Phase Syndrome
- Idiopathic Hypersomnia
- Insomnia
- Narcolepsy
- Restless Leg Syndrome
- Sleep Apnea
- Sleep disturbances as a comorbidity
Inpatient and Outpatient Studies Across Phase I-IV Trials
- Driving simulator studies
- Early-phase PSG-intensive programs
- Healthy geriatric sleep studies
- Jet lag studies
- Late-phase patient-reported sleep programs
- Outpatient insomnia
- Sleep disturbance in Alzheimer’s disease
Industry-Leading Sleep Experts
ERG’s industry-leading experts have decades of clinical trial experience and membership in the American Academy of Sleep Medicine. Our principal investigators lead teams of skilled clinical research coordinators and full-time sleep technicians.
ERG’s Experienced Sleep Team
Jim Aukstuolis, MD
Robert Billingsley, Jr., MD
Otto Dueno, MD
Arthur Flippin, MD
Daniel Gruener, MD
George Konis, MD
Daniel Lawler, MD
Stephen Thein, PhD
Specialized Resources for Sleep Clinical Research
ERG has strategically selected sites in which to conduct polysomnographic (PSG) sleep studies, giving careful consideration to unit design and equipment purchases in order to meet the needs of these specialized trials. Our dedicated sleep labs are equipped with digital and paper PSG capabilities with high-precision monitoring instruments and wireless amplifiers for maximum patient comfort; Multiple Sleep Latency Tests (MSLT), Maintenance of Wakefulness Tests (MWT), electroencephalograms (EEG), electromyographs (EMG), digital, 32-channel oximeters; SEDT (secure electronic data transfer); and a lab draw station complete with a centrifuge and a refrigerator for sample storage.
PSG Testing in CNS Clinical Trials
In addition to polysomnography-required sleep studies, PSG testing can be a critical assessment used as primary or secondary endpoints for CNS clinical trials.
ERG portfolio sites in low-sleep states
Targeted Patient Recruitment
Our well-established, centralized recruitment team—part of the ERG infrastructure—works with on-site recruitment specialists to develop a plan to target the optimal patient population for a specific study. Each ERG site has a robust database of volunteers reporting some form of sleep disorder. Mining that database, augmented with community outreach and physician referral programs, our specialists focus on the appropriate demographics to yield the greatest rate of return.
Spotlight
Stephen Thein, PhD
- Conducted 380+ clinical studies
- Sought-after opinion leader in sleep disorders
- Industry-leading researcher in the field of memory and Alzheimer’s disease
- Authored 20+ peer-reviewed journal articles and scientific abstracts
- Served on many scientific advisory boards
Study of JZP-110 presented at APSS
A 12-week, double-blind, placebo-controlled, parallel-designed study evaluated the effect of JZP-110 for the treatment of excessive sleepiness in patients with obstructive sleep apnea.