Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona
|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|
|Primary Completion Date :||December 2010|
|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
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|