The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia

Completed · Phase 4

Conditions studied: Primary Insomnia

In brief

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 severity of insomnia.

Key facts

Study ID

NCT00124384

Run by

University of Rochester

People needed

40

Starts

2005-01-01

Expected to finish

2007-08-01

Last updated by the study team

2008-04-23

Who can join

Age: 25 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• As above

Where it is running

• University of Rochester Sleep and Neurophysiology Research Lab — Rochester, New York, United States

Full record on ClinicalTrials.gov

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