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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 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.

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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.

Conditions Studied

Primary Insomnia

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

FieldValue
Enrollment Target 144 participants
Start Date 2013-01
Est. Completion 2013-08
Phase NA

Sponsor

Cereve

2 total trials

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What the Registry Record Tells You About NCT01790256

The ClinicalTrials.gov registry entry for NCT01790256 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 114-participant average among 12 other Primary Insomnia trials with a reported enrollment target (26% higher). The listed sponsor is Cereve, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 9 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.