Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT00869167
Status:
TERMINATED
Last Update Posted:
2013-05-01
First Post:
2009-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ramelteon for Insomnia Comorbid With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D001249', 'term': 'Asthma'}], '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'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C495910', 'term': 'ramelteon'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lubs@sutterhealth.org', 'phone': '415-923-3421', 'title': 'Brandon Lu, M.D., M.S.', 'organization': 'California Pacific Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Recruitment difficulties led to only 3 participants in the study. Only 2 participants finished the study.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ramelteon', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before', 'otherNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pittsburgh Sleep Quality Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and post-treatment (at end of 5 weeks)', 'description': 'The change in ISI and PSQI from baseline to end of study will be compared between the two groups.\n\nPSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.'}, {'type': 'SECONDARY', 'title': 'Daytime Sleepiness (Epworth Sleepiness Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and post-treatment (at end of 5 weeks)', 'description': 'Score of 0-24, with 24 being the most sleepy', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.'}, {'type': 'SECONDARY', 'title': 'Daytime Performance (Digit Symbol Substitution Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and post-treatment (at end of 5 weeks)', 'description': 'DSST tests the number of correct digit-symbol pairs that an individual can identify within an allotted period (60-90 sec). It test memory and concentration, among other parameters.\n\nDSST score can range from 0-125, with 125 being the most number correct during the allotted time period.', 'unitOfMeasure': 'Number correct', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.'}, {'type': 'SECONDARY', 'title': 'Daytime Lung Function (Peak Flow Monitoring) in Liter/Min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before'}], 'timeFrame': 'baseline and during treatment period (during 5th week)', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure was added during the study and no subjects completed the measure.'}, {'type': 'PRIMARY', 'title': 'Insomnia Severity Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ramelteon', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before bedtime'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before bedtime'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.5', 'spread': '6.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 weeks', 'description': 'The change in ISI and PSQI from baseline to end of study will be compared between the two groups.\n\nPSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The 2 subjects in the Ramelteon group completed the study. The 1 subject in the placebo group did not complete the study.', 'anticipatedPostingDate': '2011-06'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ramelteon', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ramelteon', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '35.6', 'spread': '6.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-26', 'studyFirstSubmitDate': '2009-03-19', 'resultsFirstSubmitDate': '2011-06-28', 'studyFirstSubmitQcDate': '2009-03-24', 'lastUpdatePostDateStruct': {'date': '2013-05-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-27', 'studyFirstPostDateStruct': {'date': '2009-03-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'baseline and post-treatment (at end of 5 weeks)', 'description': 'The change in ISI and PSQI from baseline to end of study will be compared between the two groups.\n\nPSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms'}, {'measure': 'Insomnia Severity Index', 'timeFrame': '5 weeks', 'description': 'The change in ISI and PSQI from baseline to end of study will be compared between the two groups.\n\nPSQI has a score range of 0-21, with lower the number being less sleep disturbances ISI has a score range of 0-28, with lower score meaning less insomnia symptoms'}], 'secondaryOutcomes': [{'measure': 'Daytime Sleepiness (Epworth Sleepiness Scale)', 'timeFrame': 'baseline and post-treatment (at end of 5 weeks)', 'description': 'Score of 0-24, with 24 being the most sleepy'}, {'measure': 'Daytime Performance (Digit Symbol Substitution Test)', 'timeFrame': 'baseline and post-treatment (at end of 5 weeks)', 'description': 'DSST tests the number of correct digit-symbol pairs that an individual can identify within an allotted period (60-90 sec). It test memory and concentration, among other parameters.\n\nDSST score can range from 0-125, with 125 being the most number correct during the allotted time period.'}, {'measure': 'Daytime Lung Function (Peak Flow Monitoring) in Liter/Min', 'timeFrame': 'baseline and during treatment period (during 5th week)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Insomnia', 'Asthma']}, 'descriptionModule': {'briefSummary': 'This trial will test the efficacy and safety of ramelteon, a selective melatonin agonist, on patients with insomnia comorbid with asthma.', 'detailedDescription': 'Subjects with insomnia comorbid with asthma will be randomized to placebo or ramelteon at night for 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18 - 60 with both insomnia and asthma.\n* Insomnia:\n\n * a complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early or sleep that is chronically nonrestorative or poor in quality,\n * the sleep difficulty occurs despite adequate opportunity and circumstances for sleep, and\n * at least one form of daytime impairment related to the nighttime sleep difficulty must be present. The sleep complaint should be present on most days for at least 3 months.\n* Additional inclusion criteria include: a subjective TST \\<6.5 h and a subjective SL \\> 45 min per night; a mean LPS \\>20 min over 2 consecutive nights by polysomnography (neither night could have been \\<15 min); a habitual bedtime between 10 PM and 1 AM; and ISI score \\> 10 (based on 0-4 scale). LPS is defined as amount of time to the first 10 minutes of continuous sleep.\n* Asthma will be diagnosed based on suggestive clinical history and either\n\n * airway hyperresponsiveness indicated by a 20% or greater decrease in FEV1 in response to inhalation of methacholine at 8 mg/mL or less\n * bronchodilator-responsive expiratory airflow limitation (if FEV1 \\< 70% of predicted value or \\< 1.5 L, improving ≥200 mL and 12% in response to 180 µg of albuterol aerosol). In addition to the above criteria, patients should have well-controlled asthma as evidenced by ACQ score \\< 1.5.\n\nExclusion Criteria:\n\n* Primary sleep pathology, other than insomnia as assessed by sleep history and confirmed by polysomnography to exclude significant sleep apnea (RDI \\> 15), periodic leg movements (movement arousal index \\> 15), REM behavior disorder; or circadian sleep-wake disorders\n* History of cognitive or other neurological disorders;\n* History of DSM-IV criteria for any major psychiatric disorder, including mania or alcohol or substance abuse;\n* Depressive symptoms as assessed by the CES-D. Subjects with a score of 22 or greater indicates that the person may be suffering from a major depression and therefore, will be referred to their physician;\n* Unstable or serious medical conditions;\n* Current, or use within the past month, of psychoactive, hypnotic, stimulant or analgesic medications (except occasionally);\n* Shift work or other types of self imposed irregular sleep schedules;\n* Obesity (BMI \\> 35 Kg/m2); or\n* Pregnancy or desire to become pregnant during the study.'}, 'identificationModule': {'nctId': 'NCT00869167', 'briefTitle': 'Ramelteon for Insomnia Comorbid With Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Ramelteon for Insomnia Comorbid With Asthma', 'orgStudyIdInfo': {'id': '07-052R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: Ramelteon', 'interventionNames': ['Drug: Ramelteon']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2: Placebo', 'interventionNames': ['Drug: Ramelteon']}], 'interventions': [{'name': 'Ramelteon', 'type': 'DRUG', 'otherNames': ['Rozerem'], 'description': 'melatonin agonist', 'armGroupLabels': ['1: Ramelteon', '2: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Brandon S Lu, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Brandon Lu', 'investigatorAffiliation': 'Northwestern University'}}}}