Comparison of Two Temperatures to Treat Insomnia

A Multi-center Prospective, Blinded, Randomized Crossover Study to Compare the Cerêve Sleep System at Two Different Temperatures in Primary Insomnia Patients

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.

Study Overview

• Status: Completed
• Conditions: Primary Insomnia
• Intervention / Treatment: Device: Cereve Sleep System at 14-16 degrees C; Device: Cereve Sleep System at 30 degrees C

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Paul Wylie
  • Florida
    • Miami, Florida, United States, 33143
      • Timothy Grant
    • Pembroke Pines, Florida, United States, 33026
      • David Seiden
    • St. Petersburg, Florida, United States, 33707
      • Neil Feldman
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Alan Lankford
    • Atlanta, Georgia, United States, 30342
      • Russell Rosenberg
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41047
      • David Mayleben
  • Missouri
    • St. Louis, Missouri, United States, 63143
      • Mark Muehlbach
  • Texas
    • Dallas, Texas, United States, 75231
      • Leon Rosenthal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Age >/= 22

Diagnosis of insomnia that meets criteria for DSM IV diagnosis of primary insomnia and International Classification of Sleep Disorders (ICSD)general insomnia criteria and RDC insomnia disorder criteria

Subjects must remain alcohol-free and avoid drugs that could affect sleep during the study.

>14 on the Insomnia Severity Index

Sleep -Wake diaries demonstrate sleep efficiency <85% on at least 50% of nights

Exclusion Criteria:

Neuropsychiatric disorders that may independently affect sleep, brain function or cognition, such as current major syndromal psychiatric disorders, including DSM-IV mood, anxiety, psychotic, and substance use disorders.

Specific exclusionary diagnoses include major depressive disorder, dysthymic disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, generalized anxiety disorder, any psychotic disorder, and any current substance use disorder.

Unstable medical conditions Raynaud's Disease

Irregular sleep schedules including shift workers;

A latency to persistent sleep < 15 on either the sleep disorder screening night or the baseline PSG sleep night;

A sleep efficiency > 85% on either the sleep disorder screening night or the baseline PSG sleep night;

An AHI (apnea hypopnea index) > 10 and/or a periodic limb movement arousal index (PLMAI) > 15 from SN1

Body Mass Index >34

Use of medications known to affect sleep or wake function

Consumption of more than one alcoholic drink per day, or more than 7 drinks per week prior to study entry.

Caffeinated beverages > 4/day or the equivalent of more than 4 cups of coffee Unable to read or understand English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cereve Sleep System at 14-16 degrees C.; Active	Device: Cereve Sleep System at 14-16 degrees C
Active Comparator: Cereve Sleep System at 30 degrees C; Active	Device: Cereve Sleep System at 30 degrees C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polysomnographically determined sleep latency as changed from baseline measures	Polysomnographically determined sleep parameters	1-2 weeks
Poloysomnographically determined sleep efficiency as changed from baseline measures		1-2 weeks

Collaborators and Investigators

• Sponsor: Cereve, Inc.
• Investigators: Principal Investigator: Alan Lankford, PhD, Sleep Center of Georgia; Principal Investigator: Russell Rosenberg, PhD, Neurotrials; Principal Investigator: Leon Rosenthal, MD, Sleep Medicine Associates of Texas; Principal Investigator: David Mayleben, PhD, Community Research; Principal Investigator: Paul Wylie, MD, Preferred Research Partners; Principal Investigator: Mark Muehlbach, PhD, Clayton Sleep Institute; Principal Investigator: David Seiden, MD, Broward Research Group; Principal Investigator: Timothy Grant, MD, Miami Research Associates; Principal Investigator: Neil Feldman, MD, Clinical Research Group of St. Petersburg

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 8, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (Estimate): February 13, 2013

Study Record Updates

• Last Update Posted (Estimate): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: Cereve CIP-003