Primary InsomniaNCT01790256
Comparison of Two Temperatures to Treat Insomnia
A study testing Cereve Sleep System at 30 degrees C and Cereve Sleep System at 14-16 degrees C in people with Primary Insomnia, run by Cereve, Inc. at 9 sites in United States.
Trial 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. 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 at 30 degrees C and Cereve Sleep System at 14-16 degrees C
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2013to Aug 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
- 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
Who cannot join
- 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.
- Specific exclusionary diagnoses include major depressive disorder, dysthymic disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, generalized anxiety disorder, any psychotic disorder, and any current substance use disorder.
- 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;
Show all 11Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Alan Lankford
Atlanta, Georgia, 30342
Russell Rosenberg
Atlanta, Georgia, 30342
David Mayleben
Crestview Hills, Kentucky, 41047
Leon Rosenthal
Dallas, Texas, 75231
Paul Wylie
Little Rock, Arkansas, 72211
Timothy Grant
Miami, Florida, 33143
David Seiden
Pembroke Pines, Florida, 33026
Mark Muehlbach
St Louis, Missouri, 63143
Neil Feldman
St. Petersburg, Florida, 33707
About this study
Official title: A Multi-center Prospective, Blinded, Randomized Crossover Study to Compare the Cerêve Sleep System at Two Different Temperatures in Primary Insomnia Patients
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.
- Conditions
- Primary Insomnia
- Being tested
- Cereve Sleep System at 30 degrees C, Cereve Sleep System at 14-16 degrees C
- 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 System at 30 degrees CDevice
Cereve Sleep System at 14-16 degrees CDevice
| Study group | Role | What they receive |
|---|---|---|
| Cereve Sleep System at 14-16 degrees C. | Active comparator | Active Receives: Device: Cereve Sleep System at 14-16 degrees C |
| Cereve Sleep System at 30 degrees C | Active comparator | Active Receives: Device: Cereve Sleep System at 30 degrees C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnographically determined sleep latency as changed from baseline measures
Polysomnographically determined sleep parameters
Measured: 1-2 weeks
Poloysomnographically determined sleep efficiency as changed from baseline measures
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2013
- Study completionAug 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 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 GeorgiaRussell Rosenberg, PhD, Principal investigator, NeurotrialsLeon Rosenthal, MD, Principal investigator, Sleep Medicine Associates of TexasDavid Mayleben, PhD, Principal investigator, Community ResearchPaul Wylie, MD, Principal investigator, Preferred Research PartnersMark Muehlbach, PhD, Principal investigator, Clayton Sleep InstituteDavid Seiden, MD, Principal investigator, Broward Research GroupTimothy Grant, MD, Principal investigator, Miami Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790256
- Sponsor's protocol ID
- Cereve CIP-003
- Status last verified
- May 2015
- First submitted
- 8 Feb 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, Blinded, Randomized Crossover Study to Compare the Cerêve Sleep System at Two Different Temperatures in Primary Insomnia Patients
- ClinicalTrials.gov ID
- NCT01790256
- Acronym / sponsor ID
- Cereve CIP-003
- Conditions
- Primary Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Cereve, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Feb 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cereve Sleep System at 14-16 degrees C. | Active comparator | Device: Cereve Sleep System at 14-16 degrees CActive |
| Cereve Sleep System at 30 degrees C | Active comparator | Device: Cereve Sleep System at 30 degrees CActive |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
- Specific exclusionary diagnoses include major depressive disorder, dysthymic disorder, bipolar disorder, panic disorder, obsessive compulsive disorder, generalized anxiety disorder, any psychotic disorder, and any current substance use disorder.
- 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;
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 System at 30 degrees C | Device | Cereve Sleep System at 30 degrees C |
| Cereve Sleep System at 14-16 degrees C | Device | Cereve Sleep System at 14-16 degrees C. |
Primary outcome
Polysomnographically determined sleep latency as changed from baseline measures
Time frame: 1-2 weeks
Polysomnographically determined sleep parameters
Poloysomnographically determined sleep efficiency as changed from baseline measures
Time frame: 1-2 weeks
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
Russell Rosenberg, PhD principal investigator
Neurotrials
Leon Rosenthal, MD principal investigator
Sleep Medicine Associates of Texas
9 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 at 30 degrees C and Cereve Sleep System at 14-16 degrees C in people with Primary Insomnia, run by Cereve, Inc. at 9 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 5 inclusion and 11 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 9 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?
Polysomnographically determined sleep latency as changed from baseline measures (time frame: 1-2 weeks). 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.