Status:
COMPLETED
Information Processing at Sleep Onset and During Sleep in Patients With Insomnia
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Primary Insomnia
Eligibility:
All Genders
25-45 years
Brief Summary
Chronic insomnia is thought to occur as a result of hyperarousal. While there is a wealth of data to support this position, there is a lack of research to define how hyperarousal interferes with sleep...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Psychophysiologic Insomnia (PI)
- These subjects will meet RDC criteria for Psychophysiologic insomnia. In addition, the complaint of disturbed sleep will have at least one of the following minimal characteristics:
- \> 30 min. sleep-onset latency (SL) (Initial Insomnia)
- \>2 awakenings per night (\>15 min. ea.) and/or wake after sleep-onset (WASO) of \> 30 min (Middle Insomnia)
- Total Sleep Time (TST) will not exceed 6 hours \[unless the Sleep Efficiency (SE) quotient is \< 80%\] and the problem frequency must be \> 4 nights/week (Severe Insomnia) with a problem duration \> 6 months (Chronic Insomnia)B .
- Inclusion Criteria for Good Sleeper Subjects
- Report that they obtain enough sleep and that their sleep is restorative
- Have a score of less than 10 on the Epworth Sleepiness Scale (ESS)50-52
- Have a score of less than 15 on the Ford Insomnia Response to Stress Test (FIRST)53
- Have a score of less than 7 on the Insomnia Severity Index (ISI)54
- Report retrospectively and prospectively \< 15 minutes to fall asleep and "wake after sleep onset time" of \< 15 minutes and a total sleep time \> 6 hoursA
- A These profiles will be evident at both intake (based on retrospective reports) and as an average from the two weeks of baseline diaries (based on prospective sampling).
- Exclusion Criteria for All Subjects
- • Unstable medical illness or acute or history of psychiatric illness (except GAD or MDD - Allowed provided that these have resolved and not recurred within 5 years) As ascertained with self report questionnaires, a clinical History, a physical exam and a clinical chemistry profile.
- To assure that the insomnia is not secondary to these factors
- Symptoms suggestive of sleep disorders other than insomnia To assure that the insomnia is not secondary to these factors
- Polysomnographic data indicating sleep disorders other than insomnia To assure that the insomnia is not secondary to these factors
- History of head injury with a sustained loss of consciousness To help assure that the EEG measures are unconfounded by brain damage
- Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence To assure that the insomnia is not secondary to these factors
- Use of CNS active medications including antidepressants and hypnotics (within 2 weeks or 5 half-lives) To help assure that the EEG measures are unconfounded by medication effects such as the "BZ artifact".
- Inadequate language comprehension To assure the quality of self report data as all the measures are in English.
- Pregnancy Excluded owing to the hormonal changes that occur with pregnancy
- Left Handedness To control for EEG differences related to handedness
- Nicotine Use To assure that the insomnia is not secondary to these factors
- Caffeine use that exceeds 2 beverages per day or occurs past 5pm in the evening.
- To assure that the insomnia is not secondary to these factors
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00680199
Start Date
June 1 2008
End Date
July 1 2010
Last Update
October 28 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Rochester Sleep and Neurophysiology Research Lab
Rochester, New York, United States, 14642