Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-02-03 @ 1:50 AM
Study NCT ID:
NCT01790256
Status:
COMPLETED
Last Update Posted:
2015-05-22
First Post:
2013-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Temperatures to Treat Insomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'dispFirstSubmitDate': '2015-02-02', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-05', 'studyFirstSubmitDate': '2013-02-08', 'dispFirstSubmitQcDate': '2015-05-05', 'studyFirstSubmitQcDate': '2013-02-12', 'dispFirstPostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Polysomnographically determined sleep latency as changed from baseline measures', 'timeFrame': '1-2 weeks', 'description': 'Polysomnographically determined sleep parameters'}, {'measure': 'Poloysomnographically determined sleep efficiency as changed from baseline measures', 'timeFrame': '1-2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Primary Insomnia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAge \\>/= 22\n\nDiagnosis 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\n\nSubjects must remain alcohol-free and avoid drugs that could affect sleep during the study.\n\n\\>14 on the Insomnia Severity Index\n\nSleep -Wake diaries demonstrate sleep efficiency \\<85% on at least 50% of nights\n\nExclusion Criteria:\n\nNeuropsychiatric 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.\n\nSpecific 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.\n\nUnstable medical conditions Raynaud's Disease\n\nIrregular sleep schedules including shift workers;\n\nA latency to persistent sleep \\< 15 on either the sleep disorder screening night or the baseline PSG sleep night;\n\nA sleep efficiency \\> 85% on either the sleep disorder screening night or the baseline PSG sleep night;\n\nAn AHI (apnea hypopnea index) \\> 10 and/or a periodic limb movement arousal index (PLMAI) \\> 15 from SN1\n\nBody Mass Index \\>34\n\nUse of medications known to affect sleep or wake function\n\nConsumption of more than one alcoholic drink per day, or more than 7 drinks per week prior to study entry.\n\nCaffeinated beverages \\> 4/day or the equivalent of more than 4 cups of coffee Unable to read or understand English"}, 'identificationModule': {'nctId': 'NCT01790256', 'briefTitle': 'Comparison of Two Temperatures to Treat Insomnia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cereve, Inc.'}, 'officialTitle': 'A Multi-center Prospective, Blinded, Randomized Crossover Study to Compare the Cerêve Sleep System at Two Different Temperatures in Primary Insomnia Patients', 'orgStudyIdInfo': {'id': 'Cereve CIP-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cereve Sleep System at 14-16 degrees C.', 'description': 'Active', 'interventionNames': ['Device: Cereve Sleep System at 14-16 degrees C']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cereve Sleep System at 30 degrees C', 'description': 'Active', 'interventionNames': ['Device: Cereve Sleep System at 30 degrees C']}], 'interventions': [{'name': 'Cereve Sleep System at 30 degrees C', 'type': 'DEVICE', 'armGroupLabels': ['Cereve Sleep System at 30 degrees C']}, {'name': 'Cereve Sleep System at 14-16 degrees C', 'type': 'DEVICE', 'armGroupLabels': ['Cereve Sleep System at 14-16 degrees C.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Paul Wylie', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Timothy Grant', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33026', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'David Seiden', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '33707', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Neil Feldman', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Alan Lankford', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Russell Rosenberg', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '41047', 'city': 'Crestview Hills', 'state': 'Kentucky', 'country': 'United States', 'facility': 'David Mayleben', 'geoPoint': {'lat': 39.02728, 'lon': -84.58494}}, {'zip': '63143', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mark Muehlbach', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Leon Rosenthal', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Alan Lankford, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sleep Center of Georgia'}, {'name': 'Russell Rosenberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neurotrials'}, {'name': 'Leon Rosenthal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sleep Medicine Associates of Texas'}, {'name': 'David Mayleben, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Community Research'}, {'name': 'Paul Wylie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Preferred Research Partners'}, {'name': 'Mark Muehlbach, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clayton Sleep Institute'}, {'name': 'David Seiden, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Broward Research Group'}, {'name': 'Timothy Grant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Miami Research Associates'}, {'name': 'Neil Feldman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Group of St. Petersburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cereve, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}