Comparison of Two Temperatures to Treat Insomnia

Study Overview
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Brief Summary
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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.

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

Conditions
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Primary Insomnia

Intervention / Treatment
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* Device: Cereve Sleep System at 30 degrees C
* Device: Cereve Sleep System at 14-16 degrees C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |