Primary InsomniaCOTENCT00680199
Information Processing at Sleep Onset and During Sleep in Patients With Insomnia
An observational study of Primary Insomnia, run by University of Rochester at 1 site in United States.
Trial 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 initiation, maintenance, and the perception of sleep quality and quantity. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Insomnia
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jul 2010
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community Sample
Who may be able to join
- 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 .
- 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
Show all 10Show fewer
- 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).
Who cannot join
- 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
Show all 13Show fewer
- 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
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
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 initiation, maintenance, and the perception of sleep quality and quantity. We propose to use Event-related Potential (ERP) techniques to evaluate information processing at sleep onset and during sleep. ERP measures of information processing have been well established in good sleepers; they have not been, however, applied to the problem of insomnia. The goal of the project is to examine the premise that the occurrence and severity of insomnia is fundamentally related to a neurobiologic preparedness to "attend to" and "identify" environmental stimuli. Following an extensive screening, patients with insomnia and good sleepers will participate in two experimental conditions, requiring that they spend four nights in the sleep laboratory over a two week period. ERP data will be gathered prior to, following, and during sleep.
The ultimate objectives for this line of research are to determine 1) if insomnia is associated with a failure to inhibit information processing at sleep onset and/or during sleep, 2) if the failure to inhibit information processing at sleep onset and/or during sleep is associated with the occurrence and/or severity of insomnia symptoms, 3) what brain regions are functioning differently so as to give rise to information processing abnormalities, and 4) the extent to which pharmacologic and/or Cognitive Behavioral treatment for insomnia alters information processing abnormalities and/or the associated brain activity.
- Conditions
- Primary Insomnia
- Keywords
- Insomnia, Primary Insomnia, Good Sleepers, ERP
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Primary Insomnia | |
| 2 | Good Sleepers |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intent of this study is to assess whether patients with insomnia exhibit an increased level of information processing (as assessed with ERP methods) at sleep onset and during polysomnographically defined sleep.
Measured: 2 years
Secondary outcomes (1)
Assess spindle and K-complex density to investigate whether the groups differ with respect to these putative markers of information processing and parse ERP trials in NREM into those with and without spindles and K-complexes in order to investigate their
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Sara Matteson, University of Rochester
- Investigators
- Sara E Matteson-Rusby, Psy.D., Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680199
- Sponsor's protocol ID
- RSRB # 20615
- Other IDs
- R21MH076855
- Acronym
- COTE
- Status last verified
- Oct 2010
- First submitted
- 15 May 2008
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Information Processing at Sleep Onset and During Sleep in Patients With Insomnia
- ClinicalTrials.gov ID
- NCT00680199
- Acronym / sponsor ID
- COTE / RSRB # 20615
- Conditions
- Primary Insomnia
- Keywords
- Insomnia, Primary Insomnia, Good Sleepers, ERP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 20 May 2008 (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.
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 initiation, maintenance, and the perception of sleep quality and quantity. We propose to use Event-related Potential (ERP) techniques to evaluate information processing at sleep onset and during sleep. ERP measures of information processing have been well established in good sleepers; they have not been, however, applied to the problem of insomnia. The goal of the project is to examine the premise that the occurrence and severity of insomnia is fundamentally related to a neurobiologic preparedness to "attend to" and "identify" environmental stimuli. Following an extensive screening, patients with insomnia and good sleepers will participate in two experimental conditions, requiring that they spend four nights in the sleep laboratory over a two week period. ERP data will be gathered prior to, following, and during sleep.
The ultimate objectives for this line of research are to determine 1) if insomnia is associated with a failure to inhibit information processing at sleep onset and/or during sleep, 2) if the failure to inhibit information processing at sleep onset and/or during sleep is associated with the occurrence and/or severity of insomnia symptoms, 3) what brain regions are functioning differently so as to give rise to information processing abnormalities, and 4) the extent to which pharmacologic and/or Cognitive Behavioral treatment for insomnia alters information processing abnormalities and/or the associated brain activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Primary Insomnia |
| 2 | – | –Good Sleepers |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community Sample
Key inclusion criteria (10 listed)
- 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 .
- Report that they obtain enough sleep and that their sleep is restorative
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The intent of this study is to assess whether patients with insomnia exhibit an increased level of information processing (as assessed with ERP methods) at sleep onset and during polysomnographically defined sleep.
Time frame: 2 years
1 secondary outcome
Assess spindle and K-complex density to investigate whether the groups differ with respect to these putative markers of information processing and parse ERP trials in NREM into those with and without spindles and K-complexes in order to investigate their
Time frame: 2 years
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 28 Oct 2015.
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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.
Sara E Matteson-Rusby, Psy.D. principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 10 inclusion and 13 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 28 Oct 2015. 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.
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?
The intent of this study is to assess whether patients with insomnia exhibit an increased level of information processing (as assessed with ERP methods) at sleep onset and during polysomnographically defined sleep. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2015.