The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
NCT ID: NCT00124384
Last Updated: 2008-04-23
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
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2005-01-31
2007-08-31
Brief Summary
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Detailed Description
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METHODS AND PROCEDURES
Schedule for Procedures.
Screening interview Sleep over night in our lab for one night 8 weeks of either behavioral or psychological therapy for insomnia 3 month post therapy follow up (two weeks of sleep diaries and one lab visit)
40 patients aged 25-80 with insomnia. All subjects will have a stable sleep/wake schedule with a preferred sleep phase between 10:00 PM and 8:00 AM. The age range is restricted to 1) minimize circadian rhythm influences on the diagnoses of Psychophysiological insomnia, 2) to increase our ability to recruit medically healthy sample, and 3) increase sample homogeneity.
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.
Treatment.
Regardless of group assignment, all subjects will 1) wear an actiwatch, 2) be seen on an individual basis for 8 weeks. Session length will be held constant and all patients will be seen by the same therapist (Wilfred Pigeon, PhD). Backup support will be provided by the Principal Investigator (Michael Perlis, PhD) or by the Clinic's Nurse Practitioner (Carla Jungquist, MSN) and 3) complete daily sleep diaries for duration of the study (from study intake until study end \[8 weeks\]).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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CBT-I
modafinil
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
25 Years
80 Years
ALL
Yes
Sponsors
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Cephalon
INDUSTRY
University of Rochester
OTHER
Responsible Party
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University of Rochester
Principal Investigators
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Michael Perlis, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester Sleep Research Lab
Locations
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University of Rochester Sleep and Neurophysiology Research Lab
Rochester, New York, United States
Countries
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References
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Perlis ML, Smith MT, Orff H, Enright T, Nowakowski S, Jungquist C, Plotkin K. The effects of modafinil and cognitive behavior therapy on sleep continuity in patients with primary insomnia. Sleep. 2004 Jun 15;27(4):715-25. doi: 10.1093/sleep/27.4.715.
Other Identifiers
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RSRB # 10306
Identifier Type: -
Identifier Source: secondary_id
C1538a/6029/IN/US
Identifier Type: -
Identifier Source: org_study_id