Comparison of Two Temperatures to Treat Insomnia

Cereve

Status: Completed

Conditions: Primary Insomnia

Treatments: Device: Cereve Sleep System at 30 degrees C; Device: Cereve Sleep System at 14-16 degrees C

Study type: Interventional

Funder types: Industry

Identifiers

NCT01790256

Cereve CIP-003

Details and patient eligibility

About

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.

Enrollment: 144 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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144 participants in 2 patient groups

Cereve Sleep System at 14-16 degrees C.

Active Comparator group

Description:

Active

Treatment:

Device: Cereve Sleep System at 14-16 degrees C

Cereve Sleep System at 30 degrees C

Active Comparator group

Description:

Active

Treatment:

Device: Cereve Sleep System at 30 degrees C