Comparison of Two Temperatures to Treat Insomnia



Status:Completed
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:22 - Any
Updated:10/3/2013
Start Date:January 2013
End Date:August 2013
Contact:Eric Nofzinger, MD
Phone:412-517-8934

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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


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.


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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