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

April 22, 2008 updated by: University of Rochester

Phase 4 Study of the Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia

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.

Study Overview

Status

Completed

Conditions

Intervention / 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]).

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Measures

Outcome Measure
Long term (3 months) effects of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

Cephalon

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

July 25, 2005

First Submitted That Met QC Criteria

July 26, 2005

First Posted (Estimate)

July 27, 2005

Study Record Updates

Last Update Posted (Estimate)

April 23, 2008

Last Update Submitted That Met QC Criteria

April 22, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1538a/6029/IN/US
  • RSRB # 10306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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