Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-30 @ 1:21 AM
Study NCT ID:
NCT01175304
Status:
COMPLETED
Last Update Posted:
2011-07-06
First Post:
2010-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona
Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Organization:
Study Overview
Official Title:
Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: