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Comparison of Two Temperatures to Treat Insomnia

Primary Purpose

Primary Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cereve Sleep System at 30 degrees C
Cereve Sleep System at 14-16 degrees C
Sponsored by
Cereve, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Paul Wylie
  • Timothy Grant
  • David Seiden
  • Neil Feldman
  • Alan Lankford
  • Russell Rosenberg
  • David Mayleben
  • Mark Muehlbach
  • Leon Rosenthal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cereve Sleep System at 14-16 degrees C.

Cereve Sleep System at 30 degrees C

Arm Description

Active

Active

Outcomes

Primary Outcome Measures

Polysomnographically determined sleep latency as changed from baseline measures
Polysomnographically determined sleep parameters
Poloysomnographically determined sleep efficiency as changed from baseline measures

Secondary Outcome Measures

Full Information

First Posted
February 8, 2013
Last Updated
May 5, 2015
Sponsor
Cereve, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01790256
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cereve, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cereve Sleep System at 14-16 degrees C.
Arm Type
Active Comparator
Arm Description
Active
Arm Title
Cereve Sleep System at 30 degrees C
Arm Type
Active Comparator
Arm Description
Active
Intervention Type
Device
Intervention Name(s)
Cereve Sleep System at 30 degrees C
Intervention Type
Device
Intervention Name(s)
Cereve Sleep System at 14-16 degrees C
Primary Outcome Measure Information:
Title
Polysomnographically determined sleep latency as changed from baseline measures
Description
Polysomnographically determined sleep parameters
Time Frame
1-2 weeks
Title
Poloysomnographically determined sleep efficiency as changed from baseline measures
Time Frame
1-2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Lankford, PhD
Organizational Affiliation
Sleep Center of Georgia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Russell Rosenberg, PhD
Organizational Affiliation
Neurotrials
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leon Rosenthal, MD
Organizational Affiliation
Sleep Medicine Associates of Texas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Mayleben, PhD
Organizational Affiliation
Community Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Wylie, MD
Organizational Affiliation
Preferred Research Partners
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Muehlbach, PhD
Organizational Affiliation
Clayton Sleep Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Seiden, MD
Organizational Affiliation
Broward Research Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy Grant, MD
Organizational Affiliation
Miami Research Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neil Feldman, MD
Organizational Affiliation
Clinical Research Group of St. Petersburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paul Wylie
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Timothy Grant
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
David Seiden
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Neil Feldman
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Facility Name
Alan Lankford
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Russell Rosenberg
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
David Mayleben
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41047
Country
United States
Facility Name
Mark Muehlbach
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States
Facility Name
Leon Rosenthal
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

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Comparison of Two Temperatures to Treat Insomnia

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