Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona
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|ClinicalTrials.gov Identifier: NCT01175304|
Recruitment Status : Completed
First Posted : August 4, 2010
Last Update Posted : July 6, 2011
|Condition or disease|
|Sleep Subjective Sleepiness Sleep Apnea|
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.
- General information and anthropometric data
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)
- Not rested during the day no matter how many hours of sleep you had
- Feeling of excessive daytime sleepiness 0.71† 0.08 0.03
- Great difficulty getting up in the morning 0.62† -0.06 -0.05
- Need for coffee, or other stimulants to stay awake during the day
- 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)
2.4. Epworth sleepiness scale
2.5. Berlin Questionnaire
Questionnaires will be answered in an anonymous and voluntary way on the part of workers.
- General and anthropometric data (Mean and Standard Deviation)
- Sleep habits: sleep latency, sleep time (night and 24 hours), satisfaction with sleep, sleep-debt, anxiolytic medication before bedtime
Prevalence of daytime sleepiness:
- Daytime sleepiness questionnaire, consisting of five items coded on a 0-4 ordinal scale (range 00-20 final score).
- Epworth sleepiness scale: range 0-24, being a value ≥ 10 indicative of daytime sleepiness.
- Association between daytime sleepiness, anthropometric variables, and variables derived from sleeping habits questionnaire.
- Prevalence of traffic accidents in itinera, and their association with daytime sleepiness, shift work or sleep apnea symptoms.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Workers in a Barcelona tertiary hospital
Workers attending annual medical checkups
- Sleeping time and sleeping schedules in a working population in a health care environment [ Time Frame: 4 months ]Number of hours of sleep during the working days and during the weekend
- Symptoms compatible with the sleep apnea syndrome [ Time Frame: 4 months ]Results of the Berlin Questionnaire
- Analyze predictors of daytime sleepiness [ Time Frame: 4 months ]Anhropometric, hours of sleep and Berlin questionnaires variables
- Frequency of perceived daytime sleepiness [ Time Frame: 4 months ]Scores of sleepiness questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175304
|Hospital Universitari Vall D' Hebron|
|Barcelona, Spain, 08035|
|Principal Investigator:||Patricia Lloberes, MD,pHD||Servei de Pneumologia Hospital Universitari Vall d'Hebron Barcelona|