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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cereve Sleep System at 14-16 degrees C. | Active Comparator | Active |
|
| Cereve Sleep System at 30 degrees C | Active Comparator | Active |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cereve Sleep System at 30 degrees C | Device |
| ||
| Cereve Sleep System at 14-16 degrees C |
| 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 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paul Wylie | Little Rock | Arkansas | 72211 | United States | ||
| Timothy Grant |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Device |
|
| Miami |
| Florida |
| 33143 |
| United States |
| David Seiden | Pembroke Pines | Florida | 33026 | United States |
| Neil Feldman | St. Petersburg | Florida | 33707 | United States |
| Alan Lankford | Atlanta | Georgia | 30342 | United States |
| Russell Rosenberg | Atlanta | Georgia | 30342 | United States |
| David Mayleben | Crestview Hills | Kentucky | 41047 | United States |
| Mark Muehlbach | St Louis | Missouri | 63143 | United States |
| Leon Rosenthal | Dallas | Texas | 75231 | United States |
| D001523 |
| Mental Disorders |