Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124384
Status:
COMPLETED
Last Update Posted:
2008-04-23
First Post:
2005-07-25
Brief Title:
The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Phase 4 Study of the Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor 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 sleepwake schedule with a preferred sleep phase between 1000 PM and 800 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 andor 2 awakenings per night of 15 minutes duration andor 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 andor 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 Clinics Nurse Practitioner Carla Jungquist MSN and 3 complete daily sleep diaries for duration of the study from study intake until study end 8 weeks
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 sleepwake schedule with a preferred sleep phase between 1000 PM and 800 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 andor 2 awakenings per night of 15 minutes duration andor 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 andor 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 Clinics 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RSRB 10306 | None | None | None |