NCT01790256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 13, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

February 8, 2013

Last Update Submit

May 5, 2015

Conditions

Primary Insomnia

Outcome Measures

Primary Outcomes (2)

  • Polysomnographically determined sleep latency as changed from baseline measures

    Polysomnographically determined sleep parameters

    1-2 weeks

  • Poloysomnographically determined sleep efficiency as changed from baseline measures

    1-2 weeks

Study Arms (2)

Cereve Sleep System at 14-16 degrees C.

ACTIVE COMPARATOR

Active

Device: Cereve Sleep System at 14-16 degrees C

Cereve Sleep System at 30 degrees C

ACTIVE COMPARATOR

Active

Device: Cereve Sleep System at 30 degrees C

Interventions

Cereve Sleep System at 30 degrees CDEVICE
Cereve Sleep System at 30 degrees C
Cereve Sleep System at 14-16 degrees CDEVICE
Cereve Sleep System at 14-16 degrees C.

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Paul Wylie

Little Rock, Arkansas, 72211, United States

Location

Timothy Grant

Miami, Florida, 33143, United States

Location

David Seiden

Pembroke Pines, Florida, 33026, United States

Location

Neil Feldman

St. Petersburg, Florida, 33707, United States

Location

Alan Lankford

Atlanta, Georgia, 30342, United States

Location

Russell Rosenberg

Atlanta, Georgia, 30342, United States

Location

David Mayleben

Crestview Hills, Kentucky, 41047, United States

Location

Mark Muehlbach

St Louis, Missouri, 63143, United States

Location

Leon Rosenthal

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Alan Lankford, PhD

    Sleep Center of Georgia

    PRINCIPAL INVESTIGATOR

  • Russell Rosenberg, PhD

    Neurotrials

    PRINCIPAL INVESTIGATOR

  • Leon Rosenthal, MD

    Sleep Medicine Associates of Texas

    PRINCIPAL INVESTIGATOR

  • David Mayleben, PhD

    Community Research

    PRINCIPAL INVESTIGATOR

  • Paul Wylie, MD

    Preferred Research Partners

    PRINCIPAL INVESTIGATOR

  • Mark Muehlbach, PhD

    Clayton Sleep Institute

    PRINCIPAL INVESTIGATOR

  • David Seiden, MD

    Broward Research Group

    PRINCIPAL INVESTIGATOR

  • Timothy Grant, MD

    Miami Research Associates

    PRINCIPAL INVESTIGATOR

  • Neil Feldman, MD

    Clinical Research Group of St. Petersburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2013

First Posted

February 13, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

US(9)