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

NCT01882699 | Completed DMC

• 1 other identifier: CIP-004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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.

Conditions

Primary Insomnia

Keywords

Insomnia

Outcome Measures

Primary Outcomes (2)

• sleep latency

  latency from time in bed to persistent sleep

  30 days

• sleep efficiency

  time asleep/time in bed

  1 month

Study Arms (1)

Cereve sleep system

EXPERIMENTAL

Cereve sleep system

Device: Cereve Sleep System

Interventions

Cereve Sleep System DEVICE

cerebral hypothermia

Cereve sleep system

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cereve, Inc.: lead

Study Sites (4)

Neil Feldman

Saint Petersburgh, 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

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 20, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

US (4)