Primary InsomniaNCT01882699
30 Days in Home Use and Home Use Patterns Over 6 Months
A study testing Cereve Sleep System in people with Primary Insomnia, run by Cereve, Inc. at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Cereve Sleep System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Alan Lankford
Atlanta, Georgia, 30342
Russell Rosenberg
Atlanta, Georgia, 30342
David Mayleben
Crestview Hills, Kentucky, 41047
Neil Feldman
Saint Petersburgh, Florida, 33707
About this study
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
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.
Read the 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.
- Conditions
- Primary Insomnia
- Being tested
- Cereve Sleep System
- Keywords
- Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cereve Sleep SystemDevice
cerebral hypothermia
| Study group | Role | What they receive |
|---|---|---|
| Cereve sleep system | Experimental | Cereve sleep system Receives: Device: Cereve Sleep System |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep latency
latency from time in bed to persistent sleep
Measured: 30 days
sleep efficiency
time asleep/time in bed
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cereve, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Lankford, PhD, Principal investigator, Sleep Center of GeorgiaDavid Mayleben, PhD, Principal investigator, Community ResearchNeil Feldman, MD, Principal investigator, Clinical Research Group of St. PetersburgRussell Rosenberg, PhD, Principal investigator, Neurotrials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882699
- Sponsor's protocol ID
- CIP-004
- Status last verified
- May 2015
- First submitted
- 30 May 2013
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01882699
- Acronym / sponsor ID
- CIP-004
- Conditions
- Primary Insomnia
- Keywords
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cereve, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cereve sleep system | Experimental | Device: Cereve Sleep SystemCereve sleep system |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cereve Sleep Systemcerebral hypothermia | Device | Cereve sleep system |
Primary outcome
sleep latency
Time frame: 30 days
latency from time in bed to persistent sleep
sleep efficiency
Time frame: 1 month
time asleep/time in bed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Lankford, PhD principal investigator
Sleep Center of Georgia
David Mayleben, PhD principal investigator
Community Research
Neil Feldman, MD principal investigator
Clinical Research Group of St. Petersburg
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cereve Sleep System in people with Primary Insomnia, run by Cereve, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep latency (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.