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Comparison of Two Temperatures to Treat Insomnia
NCT01790256 · View on ClinicalTrials.gov ↗
Study Summary
Insomnia patients demonstrate subjective and physiological hyperarousal. The Cereve Sleep System has been proposed as a clinical treatment to reverse this hyperarousal in insomnia patients. The current study is a two dose study to determine the optimal temperature for the Cereve Sleep System. Primary outcome measures include EEG sleep measured sleep latency and sleep efficiency.
Conditions Studied
Interventions
- DEVICE Cereve Sleep System at 30 degrees C
- DEVICE Cereve Sleep System at 14-16 degrees C
Study Locations (9)
Florida
- Timothy Grant — Miami
- David Seiden — Pembroke Pines
- Neil Feldman — St. Petersburg
Georgia
- Alan Lankford — Atlanta
- Russell Rosenberg — Atlanta
Arkansas
- Paul Wylie — Little Rock
Kentucky
- David Mayleben — Crestview Hills
Missouri
- Mark Muehlbach — St Louis
Texas
- Leon Rosenthal — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01790256
The ClinicalTrials.gov registry entry for NCT01790256 describes a study currently listed as completed. It is categorized as NA, 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 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cereve, which has 1 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 2 interventions — of which Cereve Sleep System at 30 degrees C 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: NCT01790256 reports 9 study locations spanning 6 distinct geographic areas — top geographies include Florida, Georgia, Arkansas. 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 NCT01790256 about?
NCT01790256 is a clinical study titled "Comparison of Two Temperatures to Treat Insomnia". Insomnia patients demonstrate subjective and physiological hyperarousal. The Cereve Sleep System has been proposed as a clinical treatment to reverse this hyperarousal in insomnia patients. The current study is a two dose study to determine the optimal temperature for the Cereve Sleep System. Primar...
What is the current status of trial NCT01790256?
This trial is currently completed. It is a NA study. The enrollment target is 144 participants. The study started on 2013-01. Estimated completion is 2013-08.
What conditions does trial NCT01790256 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 NCT01790256?
The interventions under investigation include: Cereve Sleep System at 30 degrees C (DEVICE), Cereve Sleep System at 14-16 degrees C (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01790256?
This trial is sponsored by Cereve, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01790256 being conducted?
This trial has 9 study locations across Arkansas, Florida, Georgia, Kentucky, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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