This study examines how treatment with the drug modafinil, by itself or in combination with behavioral treatment for insomnia, may improve daytime functioning and/or diminish the severity of insomnia.

Condition	Intervention	Phase
Primary Insomnia	Behavior: CBT-I  Drug: modafinil	Phase IV

Further Study Details: 

Primary Outcomes: Change in sleep latency, wake after sleep onset, sleep efficiency; efficacy of modafinil and the combination of modfinil and CBT-I on previously mentioned outcome measures
Secondary Outcomes: Long term (3 months)effects of treatment
Expected Total Enrollment:  40

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.

In our first study (Journal SLEEP, in press), it was found that 100 mg QAM of modafinil

· alone did not produce significant positive change but there was preliminary evidence that the medication reduced sleep latency.

· in combination with CBT treatment for insomnia, did not significantly alter treatment outcome. That is, there were no subtractive or additive effects on sleep continuity measures.

· appeared to reduce the daytime sleepiness associated with treatment (irrespective of sleep outcomes). ` · appeared to modestly affect compliance as measured by adherence to the prescribed phase delay in bedtime that comes with sleep restriction therapy.

The goal of the present study is to assess whether an alternate dosing strategy (different dose and time of dose) can produce independent or interactive positive effects on sleep continuity and/or potentiate the effects previously observed.

METHODS AND PROCEDURES

Schedule for Procedures.

After a telephone screening and an initial medical and psychiatric evaluation (inclusive of blood and urine chemistries) subjects will undergo a screening PSG study. Following the PSG study, all subjects will begin meeting with our clinician on a weekly basis for a period of 8 weeks. During the first week (week following first clinical contact) all subjects will receive BID placebos. At the end of the one-week placebo wash-in interval, subjects will be randomized to one of four treatment conditions for a period of 4 weeks. At the end of the active treatment phase subjects will receive two weeks of BID placebos. At three months post treatment subjects will be asked to wear an actiwatch for two weeks and fill out two weeks of sleep diaries.

Subjects

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. 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 somaticized 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.

All subjects will be studied polysomnographically prior to randomization to determine their eligibility (rule out occult sleep disorders). Subjects will be studied in lab for one night. This will serve to screen for occult sleep disorders (OSA, PLMs, etc.).

Treatment.

Regardless of group assignment, all subjects will 1) wear an actiwatch, 2) be seen on an individual basis for 8 weeks: 1 week placebo wash-in. 4 weeks treatment and 2 weeks placebo washout. 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]).

Treatment Procedures: Modafinil & Placebo

The four treatment conditions are as follows:

Modafinil (100 mg AM and 100 mg 2 pm ) + CBT-I Modafinil (100 mg AM and 100 mg 2 pm ) + Weekly Monitoring

Placebo (1 in the AM and 1 at 2 pm ) + CBT-I Placebo (1 in the AM and 1 at 2 pm ) + Weekly Monitoring

Treatment Procedures: Behavioral Treatment Insomnia treatment will be provided at our Behavioral Sleep Medicine clinic The clinic was founded in 1997, is directed by Michael L. Perlis, PhD and is staffed by a team of two psychologists. The clinic is a dedicated service that provides only empirically validated behavioral treatments for sleep disorders. Our treatment protocol for insomnia has been standardized and has a treatment manual which dictates how therapy is undertaken on a session by session basis. The Manual due to be published within the next year by Springer Press.

Ages Eligible for Study:  25 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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. 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 somaticized 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00124384

Carla Jungquist, MSN      585-275-2900    Carla_Jungquist@URMC.Rochester.edu
Michael Perlis, PhD.      585-275-3568    Michael_Perlis@URMC.Rochester.edu

New York
      University of Rochester Sleep and Neurophysiology Research Lab, Rochester,  New York,  14642,  United States; Recruiting

Study chairs or principal investigators

Michael Perlis, PhD,  Principal Investigator,  University of Rochester Sleep Research Lab   

Study ID Numbers:  C1538a/6029/IN/US; RSRB # 10306
Last Updated:  August 1, 2005
Record first received:  July 26, 2005
ClinicalTrials.gov Identifier:  NCT00124384
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-02