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

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01175304
First received: July 27, 2010
Last updated: July 4, 2011
Last verified: July 2011

July 27, 2010
July 4, 2011
August 2010
December 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01175304 on ClinicalTrials.gov Archive Site
  • Symptoms compatible with the sleep apnea syndrome [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Results of the Berlin Questionnaire
  • Analyze predictors of daytime sleepiness [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Anhropometric, hours of sleep and Berlin questionnaires variables
  • Frequency of perceived daytime sleepiness [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Scores of sleepiness questionnaires
Same as current
Not Provided
Not Provided
 
Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona
Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona

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.

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.
  4. Prevalence of traffic accidents in itinera, and their association with daytime sleepiness, shift work or sleep apnea symptoms.
  5. 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.
Observational
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Community sample of 500 consecutive tertiary hospital workers in the city of Barcelona (Spain), attending annual checkups at the Hospital's medical department.

  • Sleep
  • Subjective Sleepiness
  • Sleep Apnea
Not Provided
Workers in a Barcelona tertiary hospital
Workers attending annual medical checkups

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Workers attending annual checkups at the Hospital's medical department.

Exclusion Criteria:

  • Pregnant women
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01175304
PR(AG)40/2009
No
Patricia Lloberes MD, phD, Servei Pneumologia Vall d'Hebron
Hospital Universitari Vall d'Hebron Research Institute
Not Provided
Principal Investigator: Patricia Lloberes, MD,pHD Servei de Pneumologia Hospital Universitari Vall d'Hebron Barcelona
Hospital Universitari Vall d'Hebron Research Institute
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP