Clinical trial NCT01175304: Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona
Official title: Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Subjective Sleepiness
Sleep Apnea
Keywords: sleep
sleep apnea
work
sleep habits
sleepiness
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2010-08-04
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
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.

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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Sleeping time and sleeping schedules in a working population in a health care environment
timeFrame: 4 months
Secondary outcomes:
measure: Symptoms compatible with the sleep apnea syndrome
timeFrame: 4 months
measure: Analyze predictors of daytime sleepiness
timeFrame: 4 months
measure: Frequency of perceived daytime sleepiness
timeFrame: 4 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D' Hebron
Study officials:
affiliation: Servei de Pneumologia Hospital Universitari Vall d'Hebron Barcelona
name: Patricia Lloberes, MD,pHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaneita Y, Ohida T, Uchiyama M, Takemura S, Kawahara K, Yokoyama E, Miyake T, Harano S, Suzuki K, Yagi Y, Kaneko A, Tsutsui T, Akashiba T. Excessive daytime sleepiness among the Japanese general population. J Epidemiol. 2005 Jan;15(1):1-8. doi: 10.2188/jea.15.1.
citation: Kim H, Young T. Subjective daytime sleepiness: dimensions and correlates in the general population. Sleep. 2005 May;28(5):625-34. doi: 10.1093/sleep/28.5.625.
citation: Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
citation: Netzer NC, Hoegel JJ, Loube D, Netzer CM, Hay B, Alvarez-Sala R, Strohl KP; Sleep in Primary Care International Study Group. Prevalence of symptoms and risk of sleep apnea in primary care. Chest. 2003 Oct;124(4):1406-14. doi: 10.1378/chest.124.4.1406.