Comparison of Two Temperatures to Treat Insomnia

Not Applicable

Completed

• Conditions: Primary Insomnia
• Interventions: Device: Cereve Sleep System at 14-16 degrees C; Device: Cereve Sleep System at 30 degrees C

• Registration Number: NCT01790256
• Lead Sponsor: Cereve, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-08
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-13
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Disposition First Submitted: 2015-02-02
• Status Verified: 2015-05
• Disposition First Submitted QC: 2015-05-05
• Last Update Submitted: 2015-05-05
• Disposition First Posted: 2015-05-22
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cereve Sleep System at 14-16 degrees C.	Cereve Sleep System at 14-16 degrees C	Active
Cereve Sleep System at 30 degrees C	Cereve Sleep System at 30 degrees C	Active

Primary Outcome Measures

Name	Time	Method
Polysomnographically determined sleep latency as changed from baseline measures	1-2 weeks	Polysomnographically determined sleep parameters
Poloysomnographically determined sleep efficiency as changed from baseline measures	1-2 weeks

Trial Locations

Locations (9)

David Seiden; 🇺🇸 Pembroke Pines, Florida, United States

Russell Rosenberg; 🇺🇸 Atlanta, Georgia, United States

Paul Wylie; 🇺🇸 Little Rock, Arkansas, United States

Timothy Grant; 🇺🇸 Miami, Florida, United States

David Mayleben; 🇺🇸 Crestview Hills, Kentucky, United States

Alan Lankford; 🇺🇸 Atlanta, Georgia, United States

Neil Feldman; 🇺🇸 St. Petersburg, Florida, United States

Mark Muehlbach; 🇺🇸 St. Louis, Missouri, United States

Leon Rosenthal; 🇺🇸 Dallas, Texas, United States