Status:
COMPLETED
30 Days in Home Use and Home Use Patterns Over 6 Months
Lead Sponsor:
Cereve, Inc.
Conditions:
Primary Insomnia
Eligibility:
All Genders
22+ years
Phase:
NA
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01882699
Start Date
May 1 2013
End Date
December 1 2013
Last Update
May 22 2015
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Neil Feldman
Saint Petersburgh, Florida, United States, 33707
2
Alan Lankford
Atlanta, Georgia, United States, 30342
3
Russell Rosenberg
Atlanta, Georgia, United States, 30342
4
David Mayleben
Crestview Hills, Kentucky, United States, 41047