Status:
COMPLETED
The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Cephalon
Conditions:
Primary Insomnia
Eligibility:
All Genders
25-80 years
Phase:
PHASE4
Brief Summary
This study examines how treatment with the drug modafinil, by itself or in combination with cognitive behavioral treatment for insomnia (CBT-I), may improve daytime functioning and/or diminish the sev...
Detailed Description
Our primary goal is to undertake a 2nd study evaluating whether Modafinil, alone or in combination with behavioral treatment for insomnia, will improve subjects' sleep continuity and/or self report da...
Eligibility Criteria
Inclusion
- 40 patients aged 25 with insomnia, will be recruited over a 3-6 month interval.
- All subjects will have a stable sleep/wake schedule with a preferred sleep phase between 10:00 PM and 8:00 AM.
- Must live in the Greater Rochester NY area
- All subjects will meet diagnostic criteria for Psychophysiological Insomnia according to the International Classification of Sleep Disorders (ICSD). Criteria are: the complaint of insomnia and impaired daytime function; an indication of learned sleep-preventing associations and somatized tension; active help seeking. The complaint of disturbed sleep will have one or more of the following characteristics: \>30 minutes to fall asleep and/or \>2 awakenings per night of \>15 minutes duration and/or wake after sleep onset time of \> 30 minutes, problem frequency \>4 nights/ week, and problem duration \>6 months. In addition, all subjects will complain of fatigue and/or sleepiness at intake.
Exclusion
- As above
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00124384
Start Date
January 1 2005
End Date
August 1 2007
Last Update
April 23 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Rochester Sleep and Neurophysiology Research Lab
Rochester, New York, United States, 14642