Comparison of Two Temperatures to Treat Insomnia

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

• Primary Insomnia

Interventions

DEVICE

Cereve Sleep System at 30 degrees C

DEVICE

Cereve Sleep System at 14-16 degrees C

Sponsors & Collaborators

• Cereve, Inc.

  lead INDUSTRY

Principal Investigators

• Alan Lankford, PhD · Sleep Center of Georgia

• Russell Rosenberg, PhD · Neurotrials

• Leon Rosenthal, MD · Sleep Medicine Associates of Texas

• David Mayleben, PhD · Community Research

• Paul Wylie, MD · Preferred Research Partners

• Mark Muehlbach, PhD · Clayton Sleep Institute

• David Seiden, MD · Broward Research Group

• Timothy Grant, MD · Miami Research Associates

• Neil Feldman, MD · Clinical Research Group of St. Petersburg

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2013-08-31

Completion

2013-08-31

Countries

• United States

Study Locations