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Comparison of Two Temperatures to Treat Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01790256
Recruitment Status : Completed
First Posted : February 13, 2013
Last Update Posted : May 22, 2015
Information provided by (Responsible Party):
Cereve, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Primary Insomnia Device: Cereve Sleep System at 30 degrees C Device: Cereve Sleep System at 14-16 degrees C Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center Prospective, Blinded, Randomized Crossover Study to Compare the Cerêve Sleep System at Two Different Temperatures in Primary Insomnia Patients
Study Start Date : January 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Active Comparator: Cereve Sleep System at 14-16 degrees C.
Device: Cereve Sleep System at 14-16 degrees C
Active Comparator: Cereve Sleep System at 30 degrees C
Device: Cereve Sleep System at 30 degrees C

Primary Outcome Measures :
  1. Polysomnographically determined sleep latency as changed from baseline measures [ Time Frame: 1-2 weeks ]
    Polysomnographically determined sleep parameters

  2. Poloysomnographically determined sleep efficiency as changed from baseline measures [ Time Frame: 1-2 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01790256

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

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Responsible Party: Cereve, Inc. Identifier: NCT01790256     History of Changes
Other Study ID Numbers: Cereve CIP-003
First Posted: February 13, 2013    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders