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Completed

NCT Number: NCT01175304

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitari Vall D' Hebron

Barcelona, 08035, Spain

About this study

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:

  • General information and anthropometric data
  • 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)

  • 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.

Data analysis:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant women

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Symptoms compatible with the sleep apnea syndrome

    Time frame: 4 months

    Results of the Berlin Questionnaire

  2. Analyze predictors of daytime sleepiness

    Time frame: 4 months

    Anhropometric, hours of sleep and Berlin questionnaires variables

  3. Frequency of perceived daytime sleepiness

    Time frame: 4 months

    Scores of sleepiness questionnaires

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 4, 2010
Registry last updated
Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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