The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
Information source: University of Rochester
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Insomnia
Intervention: CBT-I (Behavioral); modafinil (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Rochester Official(s) and/or principal investigator(s):
Michael Perlis, PhD, Principal Investigator, Affiliation: University of Rochester Sleep Research Lab
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.
Clinical Details
Official title: Phase 4 Study of the Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
Study design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: 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 outcome: Long term (3 months) effects of treatment
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 daytime function.
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]).
Eligibility
Minimum age: 25 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- As above
Locations and Contacts
University of Rochester Sleep and Neurophysiology Research Lab, Rochester, New York 14642, United States
Additional Information
Participant recruitment site
Related publications: 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.
Starting date: January 2005
Ending date: August 2007
Last updated: April 22, 2008
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