Comparison of Two Temperatures to Treat Insomnia

Completed · Not applicable

Conditions studied: Primary Insomnia

In brief

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.

Key facts

Study ID

NCT01790256

Run by

Cereve, Inc.

People needed

144

Starts

2013-01-01

Expected to finish

2013-08-01

Last updated by the study team

2015-05-22

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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