Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona
| Tracking Information | |||||
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| First Received Date ICMJE | July 27, 2010 | ||||
| Last Updated Date | July 4, 2011 | ||||
| Start Date ICMJE | August 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Sleeping time and sleeping schedules in a working population in a health care environment [ Time Frame: 4 months ] [ Designated as safety issue: No ] Number of hours of sleep during the working days and during the weekend |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01175304 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona | ||||
| Official Title ICMJE | Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. Assuming a prevalence of excessive daytime sleepiness of 20 ± 5% with a confidence interval of 95% the number of subjects to be studied is 500. Methods:
2.1. General questionnaire, working schedules and anthropometric data 2.2. Sleeping habits questionnaire 2.3. Frequency of perceived daytime sleepiness (5 item questionnaire(Kim H, Young T.Sleep 2005;28:625-634)
2.4. Epworth sleepiness scale 2.5. Berlin Questionnaire Questionnaires will be answered in an anonymous and voluntary way on the part of workers. Data analysis:
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Ecologic or Community Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Community sample of 500 consecutive tertiary hospital workers in the city of Barcelona (Spain), attending annual checkups at the Hospital's medical department. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Workers in a Barcelona tertiary hospital
Workers attending annual medical checkups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 500 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Spain | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01175304 | ||||
| Other Study ID Numbers ICMJE | PR(AG)40/2009 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Patricia Lloberes MD, phD, Servei Pneumologia Vall d'Hebron | ||||
| Study Sponsor ICMJE | Hospital Universitari Vall d'Hebron Research Institute | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hospital Universitari Vall d'Hebron Research Institute | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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