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NCT01960452 · ClinicalTrials.gov registry record
A High Density EEG Comparison of Sleep Patterns in Insomnia
A clinical trial of Primary Insomnia, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- 45
- Enrollment target
- 1
- Study location
NCT01960452: Completed study of Primary Insomnia, sponsored by University of Wisconsin, Madison.
NCT01960452 is a study of Primary Insomnia that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 45 participants, below the 122-participant average among 12 other Primary Insomnia trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01960452, a study of Primary Insomnia, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The difference in spontaneous NREM sleep (stage N2 or N3) EEG power between subjects with insomnia and good sleeping controls measured with 256 channel high-density EEG equipment. Reported here is the median spectral power estimated using Welch's method (MATLAB function pwelch) across all 6 second epochs staged by a registered sleep technician as NREM sleep stage N2 or N3 sleep. The median spectral estimate across all NREM epochs was used to estimate spectral power for each subject as this value
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 |
What the finished NCT01960452 record still lists
NCT01960452 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 122-participant average among 12 other Primary Insomnia trials with a reported enrollment target (63% lower).
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.
NCT01960452 reports a single indexed study location in Wisconsin.
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.
What interventions are being tested in trial NCT01960452?
The interventions under investigation include: Serial awakenings (BEHAVIORAL).
Who is sponsoring clinical trial NCT01960452?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Primary Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01960452's enrollment target sits among peer trials
45 6th of 12 higher than 7 of 12 other Primary Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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