The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
Phase 4 Study of the Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
2 other identifiers
interventional
40
1 country
1
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 severity of insomnia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2005
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 25, 2005
CompletedFirst Posted
Study publicly available on registry
July 27, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedApril 23, 2008
April 1, 2008
2.6 years
July 25, 2005
April 22, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in sleep latency, wake after sleep onset, sleep efficiency; efficacy of modafinil and the combination of modafinil and CBT-I on previously mentioned outcome measures
Secondary Outcomes (1)
Long term (3 months) effects of treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- Cephaloncollaborator
Study Sites (1)
University of Rochester Sleep and Neurophysiology Research Lab
Rochester, New York, 14642, United States
Related Publications (1)
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.
PMID: 15283007BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Perlis, PhD
University of Rochester Sleep Research Lab
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 25, 2005
First Posted
July 27, 2005
Study Start
January 1, 2005
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
April 23, 2008
Record last verified: 2008-04