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NCT01790256 · ClinicalTrials.gov registry record · NA
Comparison of Two Temperatures to Treat Insomnia
A NA study of Primary Insomnia, sponsored by Cereve.
- Completed
- Registry status
- NA
- Development phase
- 144
- Enrollment target
- 9
- Study locations
NCT01790256: Completed NA study of Primary Insomnia, sponsored by Cereve.
NCT01790256 is a NA study of Primary Insomnia that has completed, run by Cereve. The registered enrollment target is 144 participants, above the 114-participant average among 12 other Primary Insomnia trials with a reported enrollment target (26% higher). The trial reports 9 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01790256, a NA study of Primary Insomnia, has completed, sponsored by Cereve.
- COMPLETED
- Registry status
- NA
- Development phase
- 144 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
Polysomnographically determined sleep parameters
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 |
What the finished NCT01790256 record still lists
NCT01790256 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, above the 114-participant average among 12 other Primary Insomnia trials with a reported enrollment target (26% higher).
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.
NCT01790256 lists 9 locations in 6 states (Florida, Georgia, Arkansas).
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.
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).
Who is sponsoring clinical trial NCT01790256?
This trial is sponsored by Cereve, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT01790256's enrollment target sits among peer trials
144 2nd of 12 the highest 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
-
Sleep Homeostasis in Primary Insomnia
COMPLETED · NA
-
The Role of Partial Reinforcement in the Long Term Management of Insomnia
COMPLETED · NA
-
Behavioral Insomnia Therapy in Primary Care
COMPLETED · NA
-
The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
COMPLETED · Phase 4
-
The Psychoneuroimmunology of Insomnia
COMPLETED
-
A High Density EEG Comparison of Sleep Patterns in Insomnia
COMPLETED
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