Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-30 @ 1:21 AM
Study NCT ID:
NCT01175304
Status:
COMPLETED
Last Update Posted:
2011-07-06
First Post:
2010-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D000077260', 'term': 'Sleepiness'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-04', 'studyFirstSubmitDate': '2010-07-27', 'studyFirstSubmitQcDate': '2010-08-03', 'lastUpdatePostDateStruct': {'date': '2011-07-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleeping time and sleeping schedules in a working population in a health care environment', 'timeFrame': '4 months', 'description': 'Number of hours of sleep during the working days and during the weekend'}], 'secondaryOutcomes': [{'measure': 'Symptoms compatible with the sleep apnea syndrome', 'timeFrame': '4 months', 'description': 'Results of the Berlin Questionnaire'}, {'measure': 'Analyze predictors of daytime sleepiness', 'timeFrame': '4 months', 'description': 'Anhropometric, hours of sleep and Berlin questionnaires variables'}, {'measure': 'Frequency of perceived daytime sleepiness', 'timeFrame': '4 months', 'description': 'Scores of sleepiness questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sleep', 'sleep apnea', 'work', 'sleep habits', 'sleepiness'], 'conditions': ['Sleep', 'Subjective Sleepiness', 'Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '15678919', 'type': 'BACKGROUND', 'citation': 'Kaneita Y, Ohida T, Uchiyama M, Takemura S, Kawahara K, Yokoyama E, Miyake T, Harano S, Suzuki K, Yagi Y, Kaneko A, Tsutsui T, Akashiba T. Excessive daytime sleepiness among the Japanese general population. J Epidemiol. 2005 Jan;15(1):1-8. doi: 10.2188/jea.15.1.'}, {'pmid': '16171277', 'type': 'BACKGROUND', 'citation': 'Kim H, Young T. Subjective daytime sleepiness: dimensions and correlates in the general population. Sleep. 2005 May;28(5):625-34. doi: 10.1093/sleep/28.5.625.'}, {'pmid': '1798888', 'type': 'BACKGROUND', 'citation': 'Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.'}, {'pmid': '14555573', 'type': 'BACKGROUND', 'citation': 'Netzer NC, Hoegel JJ, Loube D, Netzer CM, Hay B, Alvarez-Sala R, Strohl KP; Sleep in Primary Care International Study Group. Prevalence of symptoms and risk of sleep apnea in primary care. Chest. 2003 Oct;124(4):1406-14. doi: 10.1378/chest.124.4.1406.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is the description of sleeping habits in a working population in the investigators health care environment, analyzing the prevalence of daytime sleepiness and symptoms compatible with the sleep apnea syndrome and finally to analyze predictors of daytime sleepiness.', 'detailedDescription': 'Descriptive study population in a working population in a tertiary hospital in Barcelona (Spain). The population will consist of subjects who come to the annual medical checkups at the hospital. Exclusion criteria: pregnant women.\n\nAssuming a prevalence of excessive daytime sleepiness of 20 ± 5% with a confidence interval of 95% the number of subjects to be studied is 500.\n\nMethods:\n\n1. General information and anthropometric data\n2. Questionnaires\n\n2.1. General questionnaire, working schedules and anthropometric data\n\n2.2. Sleeping habits questionnaire\n\n2.3. Frequency of perceived daytime sleepiness (5 item questionnaire(Kim H, Young T.Sleep 2005;28:625-634)\n\n1. Not rested during the day no matter how many hours of sleep you had\n2. Feeling of excessive daytime sleepiness 0.71† 0.08 0.03\n3. Great difficulty getting up in the morning 0.62† -0.06 -0.05\n4. Need for coffee, or other stimulants to stay awake during the day\n5. Falling asleep or dozing momentarily at meetings, church, etc. (item responses (frequency per month): 0=never, 1=rarely (once), 2= sometimes(2-4), 3 (often (5-15), 4=almost always (16-30)\n\n2.4. Epworth sleepiness scale\n\n2.5. Berlin Questionnaire\n\nQuestionnaires will be answered in an anonymous and voluntary way on the part of workers.\n\nData analysis:\n\n1. General and anthropometric data (Mean and Standard Deviation)\n2. Sleep habits: sleep latency, sleep time (night and 24 hours), satisfaction with sleep, sleep-debt, anxiolytic medication before bedtime\n3. Prevalence of daytime sleepiness:\n\n * Daytime sleepiness questionnaire, consisting of five items coded on a 0-4 ordinal scale (range 00-20 final score).\n * Epworth sleepiness scale: range 0-24, being a value ≥ 10 indicative of daytime sleepiness.\n * Association between daytime sleepiness, anthropometric variables, and variables derived from sleeping habits questionnaire.\n4. Prevalence of traffic accidents in itinera, and their association with daytime sleepiness, shift work or sleep apnea symptoms.\n5. Berlin Questionnaire: - Category 1 positive with 2 or more positive answers to questions 2-6 - Category 2 positive with 2 or more positive answers to questions 7-9 - Category 3 positive response with a positive and / or a BMI\\> 30 or more positive categories indicates a high probability of sleep apnea syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Community sample of 500 consecutive tertiary hospital workers in the city of Barcelona (Spain), attending annual checkups at the Hospital's medical department.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Workers attending annual checkups at the Hospital's medical department.\n\nExclusion Criteria:\n\n* Pregnant women"}, 'identificationModule': {'nctId': 'NCT01175304', 'briefTitle': 'Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona', 'orgStudyIdInfo': {'id': 'PR(AG)40/2009'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Workers in a Barcelona tertiary hospital', 'description': 'Workers attending annual medical checkups'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall D' Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Patricia Lloberes, MD,pHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Servei de Pneumologia Hospital Universitari Vall d'Hebron Barcelona"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Patricia Lloberes MD, phD', 'oldOrganization': "Servei Pneumologia Vall d'Hebron"}}}}