Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
144 participants
INTERVENTIONAL
2013-01-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Cereve Sleep System at 14-16 degrees C.
Active
Cereve Sleep System at 14-16 degrees C
Cereve Sleep System at 30 degrees C
Active
Cereve Sleep System at 30 degrees C
Interventions
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Cereve Sleep System at 30 degrees C
Cereve Sleep System at 14-16 degrees C
Eligibility Criteria
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Inclusion Criteria
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
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
22 Years
ALL
No
Sponsors
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Cereve, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alan Lankford, PhD
Role: PRINCIPAL_INVESTIGATOR
Sleep Center of Georgia
Russell Rosenberg, PhD
Role: PRINCIPAL_INVESTIGATOR
Neurotrials
Leon Rosenthal, MD
Role: PRINCIPAL_INVESTIGATOR
Sleep Medicine Associates of Texas
David Mayleben, PhD
Role: PRINCIPAL_INVESTIGATOR
Community Research
Paul Wylie, MD
Role: PRINCIPAL_INVESTIGATOR
Preferred Research Partners
Mark Muehlbach, PhD
Role: PRINCIPAL_INVESTIGATOR
Clayton Sleep Institute
David Seiden, MD
Role: PRINCIPAL_INVESTIGATOR
Broward Research Group
Timothy Grant, MD
Role: PRINCIPAL_INVESTIGATOR
Miami Research Associates
Neil Feldman, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Research Group of St. Petersburg
Locations
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Paul Wylie
Little Rock, Arkansas, United States
Timothy Grant
Miami, Florida, United States
David Seiden
Pembroke Pines, Florida, United States
Neil Feldman
St. Petersburg, Florida, United States
Alan Lankford
Atlanta, Georgia, United States
Russell Rosenberg
Atlanta, Georgia, United States
David Mayleben
Crestview Hills, Kentucky, United States
Mark Muehlbach
St Louis, Missouri, United States
Leon Rosenthal
Dallas, Texas, United States
Countries
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Other Identifiers
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Cereve CIP-003
Identifier Type: -
Identifier Source: org_study_id
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