Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona

Sponsor
Hospital Universitari Vall d'Hebron Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01175304
Collaborator
(none)
500
1
4
124.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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:
    1. General information and anthropometric data

    2. Questionnaires

    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)

    1. Not rested during the day no matter how many hours of sleep you had

    2. Feeling of excessive daytime sleepiness 0.71† 0.08 0.03

    3. Great difficulty getting up in the morning 0.62† -0.06 -0.05

    4. Need for coffee, or other stimulants to stay awake during the day

    5. 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.

    Data analysis:
    1. General and anthropometric data (Mean and Standard Deviation)

    2. Sleep habits: sleep latency, sleep time (night and 24 hours), satisfaction with sleep, sleep-debt, anxiolytic medication before bedtime

    3. 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.

    1. Prevalence of traffic accidents in itinera, and their association with daytime sleepiness, shift work or sleep apnea symptoms.

    2. 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 Design

    Study Type:
    Observational
    Actual Enrollment :
    500 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona
    Study Start Date :
    Aug 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Workers in a Barcelona tertiary hospital

    Workers attending annual medical checkups

    Outcome Measures

    Primary Outcome Measures

    1. Sleeping time and sleeping schedules in a working population in a health care environment [4 months]

      Number of hours of sleep during the working days and during the weekend

    Secondary Outcome Measures

    1. Symptoms compatible with the sleep apnea syndrome [4 months]

      Results of the Berlin Questionnaire

    2. Analyze predictors of daytime sleepiness [4 months]

      Anhropometric, hours of sleep and Berlin questionnaires variables

    3. Frequency of perceived daytime sleepiness [4 months]

      Scores of sleepiness questionnaires

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Workers attending annual checkups at the Hospital's medical department.
    Exclusion Criteria:
    • Pregnant women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitari Vall D' Hebron Barcelona Spain 08035

    Sponsors and Collaborators

    • Hospital Universitari Vall d'Hebron Research Institute

    Investigators

    • Principal Investigator: Patricia Lloberes, MD,pHD, Servei de Pneumologia Hospital Universitari Vall d'Hebron Barcelona

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01175304
    Other Study ID Numbers:
    • PR(AG)40/2009
    First Posted:
    Aug 4, 2010
    Last Update Posted:
    Jul 6, 2011
    Last Verified:
    Jul 1, 2011
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 6, 2011