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
  Purpose

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
Sleep
Subjective Sleepiness
Sleep Apnea

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 500
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Workers in a Barcelona tertiary hospital
Workers attending annual medical checkups

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.
  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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175304

Locations
Spain
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
  More Information

Publications:
Responsible Party: Patricia Lloberes MD, phD, Servei Pneumologia Vall d'Hebron
ClinicalTrials.gov Identifier: NCT01175304     History of Changes
Other Study ID Numbers: PR(AG)40/2009
Study First Received: July 27, 2010
Last Updated: July 4, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
sleep
sleep apnea
work
sleep habits
sleepiness

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 23, 2014