Clinical trial NCT01790256: Comparison of Two Temperatures to Treat Insomnia
Official title: A Multi-center Prospective, Blinded, Randomized Crossover Study to Compare the Cerêve Sleep System at Two Different Temperatures in Primary Insomnia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Insomnia
Lead sponsor: Cereve, Inc.
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 144
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Polysomnographically determined sleep latency as changed from baseline measures
timeFrame: 1-2 weeks
measure: Poloysomnographically determined sleep efficiency as changed from baseline measures
timeFrame: 1-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Paul Wylie
state: Arkansas
city: Miami
country: United States
facility: Timothy Grant
state: Florida
city: Pembroke Pines
country: United States
facility: David Seiden
state: Florida
city: St. Petersburg
country: United States
facility: Neil Feldman
state: Florida
city: Atlanta
country: United States
facility: Alan Lankford
state: Georgia
city: Atlanta
country: United States
facility: Russell Rosenberg
state: Georgia
city: Crestview Hills
country: United States
facility: David Mayleben
state: Kentucky
city: St. Louis
country: United States
facility: Mark Muehlbach
state: Missouri
city: Dallas
country: United States
facility: Leon Rosenthal
state: Texas
Study officials:
affiliation: Sleep Center of Georgia
name: Alan Lankford, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurotrials
name: Russell Rosenberg, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sleep Medicine Associates of Texas
name: Leon Rosenthal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Community Research
name: David Mayleben, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Preferred Research Partners
name: Paul Wylie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clayton Sleep Institute
name: Mark Muehlbach, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Broward Research Group
name: David Seiden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Miami Research Associates
name: Timothy Grant, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Group of St. Petersburg
name: Neil Feldman, MD
role: PRINCIPAL_INVESTIGATOR
References: