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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01175304
• Other study ID #: PR(AG)40/2009
• Status: Completed
• Phase: N/A
• First received: July 27, 2010
• Last updated: July 4, 2011
• Start date: August 2010
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant women

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Sleep
• Sleep Apnea
• Subjective Sleepiness

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall D' Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. — View 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. — View Citation

Kim H, Young T. Subjective daytime sleepiness: dimensions and correlates in the general population. Sleep. 2005 May;28(5):625-34. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleeping time and sleeping schedules in a working population in a health care environment	Number of hours of sleep during the working days and during the weekend	4 months	No
Secondary	Symptoms compatible with the sleep apnea syndrome	Results of the Berlin Questionnaire	4 months	No
Secondary	Analyze predictors of daytime sleepiness	Anhropometric, hours of sleep and Berlin questionnaires variables	4 months	No
Secondary	Frequency of perceived daytime sleepiness	Scores of sleepiness questionnaires	4 months	No