Primary InsomniaPhase 4NCT00124384
The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
A Phase 4 study testing CBT-I and modafinil in people with Primary Insomnia, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- CBT-I and modafinil
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Aug 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- As above
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Sleep and Neurophysiology Research Lab
Rochester, New York, 14642
About this study
Official title: 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.
Read the 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]).
- Conditions
- Primary Insomnia
- Being tested
- CBT-I, modafinil
- Keywords
- primary insomnia, stimulants, cognitive behavioral therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-IBehavioural
modafinilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2005 (estimated)
- Study startJan 2005
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Investigators
- Michael Perlis, PhD, Principal investigator, University of Rochester Sleep Research Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124384
- Sponsor's protocol ID
- C1538a/6029/IN/US
- Other IDs
- RSRB # 10306
- Status last verified
- Apr 2008
- First submitted
- 25 Jul 2005
- Last updated
- 23 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1093/sleep/27.4.715.
PubMed 15283007
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of the Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
- ClinicalTrials.gov ID
- NCT00124384
- Acronym / sponsor ID
- C1538a/6029/IN/US
- Conditions
- Primary Insomnia
- Keywords
- primary insomnia, stimulants, cognitive behavioral therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Jan 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 27 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- As above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-I | Behavioural | – |
| modafinil | Drug | – |
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
1 secondary outcome
Long term (3 months) effects of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2008.
- Background: PubMed 15283007Perlis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Perlis, PhD principal investigator
University of Rochester Sleep Research Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CBT-I and modafinil in people with Primary Insomnia, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00124384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2008.