Sleep Disorder CRO

Specialized CRO for Sleep Disorder Clinical Studies

Clinical trials for sleep disorders require access to investigational sites with specialized facilities and equipment. Lotus works hand-in-hand with Evolution Research Group’s (ERG) specialized sleep labs and expert staff to advance new therapies in both early- and late-phase sleep trials. With 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.

Sleep Disorder Studies

ERG sites with PSG equipment and sleep centers

Affiliate Sleep Centers

Note: Statistics combine experience from both Lotus Clinical Research and Evolution Research Group’s network of clinical research sites

Sleep as a Secondary Endpoint

In addition to primary endpoint studies, we also work with clients who are assessing sleep disturbance as a secondary outcome measure in psychiatric and neurological disorders.

Examples include:

ERG’s specialized sites are uniquely positioned to conduct these complex inpatient trials given the flexibility of the facilities, customized PSG bedrooms, and 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 & 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

Dedicated Sleep Labs to Support Clinical Research

Careful consideration to unit design and equipment enable Lotus and ERG to meet the needs of specialized sleep trials that require polysomnographic (PSG) capabilities. This is often a a critical assessment used as primary or secondary endpoints for Neurology trials as well.

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)
Lab draw station complete with a centrifuge and a refrigerator for sample storage

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.