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

NCT ID: NCT01175304

Last Updated: 2011-07-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2010-12-31

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.

Conditions

Sleep; Subjective Sleepiness; Sleep Apnea

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Workers in a Barcelona tertiary hospital

Workers attending annual medical checkups

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnant women

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Servei Pneumologia Vall d'Hebron

Principal Investigators

Patricia Lloberes, MD,pHD

Role: PRINCIPAL_INVESTIGATOR

Servei de Pneumologia Hospital Universitari Vall d'Hebron Barcelona

Locations

Hospital Universitari Vall D' Hebron

Barcelona, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 15678919 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16171277 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1798888 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14555573 (View on PubMed)

Other Identifiers

PR(AG)40/2009

Identifier Type: -

Identifier Source: org_study_id