Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2006-09-30
2007-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EVT 201
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* over the last three months, must have a normal bedtime of between 9 pm and 1 am and a time in bed of at least 7 hours
* must be able to attend the Sleep Center for two consecutive nights on four occasions over a two month period
* must be willing and able to complete a sleep diary and questionnaires
Exclusion Criteria
* must not have a major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder
* must not be currently using any medication know to affect sleep e.g. hypnotics, anxiolytics,antidepressants, antihistamines, anticonvulsants
* must not intentionally nap 3 (or more) times per week
* must not smoke more than 10 cigarettes per day and /or be able not to smoke without distress or discomfort for the duration of visits to the sleep laboratory ( i.e. approximately 12 hours)
21 Years
64 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Evotec Neurosciences GmbH
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James K Walsh, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Luke's Hospital, Sleep Medicine and Research Center, Chesterfield, MI
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St Petersburg Sleep Disorders Center
St. Petersburg, Florida, United States
The Sleep Disorders Center of Georgia, Peachtree Dunwoody Medical Center,5505 Peachtree Dunwoody Road, Suite 548
Atlanta, Georgia, United States
Vince and Associates Clinical Research
Overland Park, Kansas, United States
St. Luke's Hospital
Chesterfield (St Louis), Missouri, United States
Tri-State Sleep Disorders Center
Cincinnati, Ohio, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2004
Identifier Type: -
Identifier Source: org_study_id