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30 Days in Home Use and Home Use Patterns Over 6 Months

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ClinicalTrials.gov Identifier: NCT01882699
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : May 22, 2015
Sponsor:
Information provided by (Responsible Party):
Cereve, Inc.

Brief Summary:

This study will build upon a previously approved protocol entitled "A multi-center prospective, blinded, randomized crossover study to compare the Cerêve Sleep System at two different temperatures in primary insomnia patients" (CIP-003; CER1-01-090). In that study, 150 insomnia patients were targeted to be randomized to complete in lab assessments of sleep using the Cerêve Sleep System. In this follow-on study, 36 patients who completed the in lab study will be enrolled to complete 2 phases of in home use of the device. In the first phase, the durability study, 30 patients are targeted to complete additional in lab assessments following 30 days of in home use of the device. In the second phase, the home use pattern study, 24 patients are targeted to complete an additional 5 months of in home use in which their use patterns will be monitored.

Hypothesis:

EEG sleep latency and sleep efficiency following 30 days in home use of the device at 14-16°C will be similar to those measures after the initial acute, 2-night use in the parent study in the 14-16°C condition. The device will demonstrate a benign safety profile over 6 months in home use.


Condition or disease Intervention/treatment Phase
Primary Insomnia Device: Cereve Sleep System Not Applicable

Detailed Description:

Study Design Objectives of the Clinical Investigation

  • Assess polysomnographically measured sleep latency and sleep efficiency following 30 days in home use of the device and compare these measures with those following initial in lab use in the CIP-003 protocol.
  • Determine the long-term use patterns of the Cerêve Sleep System in the environment of intended use.

Study Design Overview A multi-center, prospective, non-randomized, two phase study to determine durability of effects following 30 days of in home use (phase I) and home use patterns over an additional 5 months in home use of the Cerêve Sleep System (phase II).

A total of 30 evaluable subjects will be targeted to complete phase I and a total of 24 evaluable subjects will be targeted to complete phase II. It is anticipated that 36 subjects will be enrolled into the CIP-004 protocol to obtain the numbers of evaluable subjects described.

During in home use in both the durability phase and the home use patterns phase, the subject will be asked to use the device for a minimum of three nights each week for at least 4 hours on each of these nights up to seven nights each week. Subjects will complete a weekly home use log throughout both phases of the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Prospective, Non-randomized Study to Determine Durability of Effectiveness of the Cerêve Sleep System Following 30 Days in Home Use and Home Use Patterns Over 6 Months
Study Start Date : May 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Experimental: Cereve sleep system
Cereve sleep system
Device: Cereve Sleep System
cerebral hypothermia




Primary Outcome Measures :
  1. sleep latency [ Time Frame: 30 days ]
    latency from time in bed to persistent sleep

  2. sleep efficiency [ Time Frame: 1 month ]
    time asleep/time in bed



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have completed the in-lab protocol CIP-003 and have signed an informed consent to participate in this follow-on study.
  • Sleep latency and sleep efficiency data are available from the 2 in-lab PSG nights from CIP-003 in the 14-16° condition, as confirmed by the core laboratory.

Exclusion Criteria:

  • Use of medications known to affect sleep or wake function (e.g., hypnotics, benzodiazepines, antidepressants, anxiolytics, antipsychotics, antihistamines, decongestants, beta blockers, corticosteroids) are excluded for the durability phase, through the in-lab studies, in this protocol; Beta blockers which do NOT cross the blood brain barrier are acceptable.
  • Consumption of more than one alcoholic drinks per day, or more than 7 drinks per week prior to study entry and during the durability phase, through the in-lab studies, in this protocol.
  • Caffeinated beverages > 4/day or the equivalent of more than 4 cups of coffee during the durability phase, through the in-lab studies, in this protocol.
  • Unable to read or understand English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882699


Locations
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United States, Florida
Neil Feldman
St Petersburgh, Florida, United States, 33707
United States, Georgia
Alan Lankford
Atlanta, Georgia, United States, 30342
Russell Rosenberg
Atlanta, Georgia, United States, 30342
United States, Kentucky
David Mayleben
Crestview HIlls, Kentucky, United States, 41047
Sponsors and Collaborators
Cereve, Inc.
Investigators
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Principal Investigator: Alan Lankford, PhD Sleep Center of Georgia
Principal Investigator: David Mayleben, PhD Community Research
Principal Investigator: Neil Feldman, MD Clinical Research Group of St. Petersburg
Principal Investigator: Russell Rosenberg, PhD Neurotrials
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Responsible Party: Cereve, Inc.
ClinicalTrials.gov Identifier: NCT01882699    
Other Study ID Numbers: CIP-004
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015
Keywords provided by Cereve, Inc.:
Insomnia
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders