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A High Density EEG Comparison of Sleep Patterns in Insomnia
NCT01960452 · View on ClinicalTrials.gov ↗
Study Summary
Insomnia, defined as a subjective report of difficulty initiating sleep, maintaining sleep, and/or non-restorative sleep, leads to significant daytime dysfunction and increased health risks. A commonly held hypothesis is that insomnia is caused by a state of hyperarousal, but the neurobiological mechanisms of hyperarousal in insomnia are poorly understood, in part because of limitations in our ability to image the brain during normal human sleep with sufficient temporal resolution. Furthermore, the efficacy of insomnia treatment is judged by subjective report of the patient and demonstration of changes in sleep latency and/or sleep amount which are generally small in magnitude; there are currently no data to demonstrate that insomnia treatments correct any functional abnormalities in the sleep process that likely contribute to neurobehavioral abnormalities and health risks. The goals of the proposed study are to use high density EEG to define abnormalities in specific aspects of sleep in insomnia patients compared to healthy sleeping control subjects to define biomarkers that will both increase our understanding of the pathophysiology of insomnia as well as provide targets to assess treatments for insomnia.
Conditions Studied
Interventions
- BEHAVIORAL Serial awakenings
Study Locations (1)
Wisconsin
- University of Wisconsin, Madison — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2013-10 |
| Est. Completion | 2017-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01960452
The ClinicalTrials.gov registry entry for NCT01960452 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 943 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Primary Insomnia appearing as the primary indexed condition, and to 1 intervention — of which Serial awakenings is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01960452 reports 1 study location spanning 1 distinct geographic area — top geographies include Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01960452 about?
NCT01960452 is a clinical study titled "A High Density EEG Comparison of Sleep Patterns in Insomnia". Insomnia, defined as a subjective report of difficulty initiating sleep, maintaining sleep, and/or non-restorative sleep, leads to significant daytime dysfunction and increased health risks. A commonly held hypothesis is that insomnia is caused by a state of hyperarousal, but the neurobiological mec...
What is the current status of trial NCT01960452?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2013-10. Estimated completion is 2017-09.
What conditions does trial NCT01960452 study?
This clinical trial studies the following conditions: Primary Insomnia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01960452?
The interventions under investigation include: Serial awakenings (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01960452?
This trial is sponsored by University of Wisconsin, Madison, which has 943 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01960452 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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