SleepNCT01175304
Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona
An observational study of Sleep and Subjective Sleepiness, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep, Subjective Sleepiness, Sleep Apnea
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2010to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Workers attending annual checkups at the Hospital's medical department.
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- General information and anthropometric data
- 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)
- Not rested during the day no matter how many hours of sleep you had
- Feeling of excessive daytime sleepiness 0.71† 0.08 0.03
- Great difficulty getting up in the morning 0.62† -0.06 -0.05
- Need for coffee, or other stimulants to stay awake during the day
- 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:
- General and anthropometric data (Mean and Standard Deviation)
- Sleep habits: sleep latency, sleep time (night and 24 hours), satisfaction with sleep, sleep-debt, anxiolytic medication before bedtime
- 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.
- Prevalence of traffic accidents in itinera, and their association with daytime sleepiness, shift work or sleep apnea symptoms.
- 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
- Keywords
- sleep, sleep apnea, work, sleep habits, sleepiness
- Medical subject headings
- Sleep Apnea Syndromes, Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Workers in a Barcelona tertiary hospital | Workers attending annual medical checkups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Secondary outcomes (3)
Symptoms compatible with the sleep apnea syndrome
Results of the Berlin Questionnaire
Measured: 4 months
Analyze predictors of daytime sleepiness
Anhropometric, hours of sleep and Berlin questionnaires variables
Measured: 4 months
Frequency of perceived daytime sleepiness
Scores of sleepiness questionnaires
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Patricia Lloberes, MD,pHD, Principal investigator, Servei de Pneumologia Hospital Universitari Vall d'Hebron Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175304
- Sponsor's protocol ID
- PR(AG)40/2009
- Status last verified
- Jul 2011
- First submitted
- 27 Jul 2010
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15678919Kim 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.
PubMed 16171277Johns 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.
PubMed 1798888Netzer 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.
PubMed 14555573
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Sleep Habits and Prevalence of Sleepiness in a Health Care Environment in Barcelona
- ClinicalTrials.gov ID
- NCT01175304
- Acronym / sponsor ID
- PR(AG)40/2009
- Conditions
- Sleep, Subjective Sleepiness, Sleep Apnea
- Keywords
- sleep, sleep apnea, work, sleep habits, sleepiness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- General information and anthropometric data
- 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)
- Not rested during the day no matter how many hours of sleep you had
- Feeling of excessive daytime sleepiness 0.71† 0.08 0.03
- Great difficulty getting up in the morning 0.62† -0.06 -0.05
- Need for coffee, or other stimulants to stay awake during the day
- 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:
- General and anthropometric data (Mean and Standard Deviation)
- Sleep habits: sleep latency, sleep time (night and 24 hours), satisfaction with sleep, sleep-debt, anxiolytic medication before bedtime
- 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.
- Prevalence of traffic accidents in itinera, and their association with daytime sleepiness, shift work or sleep apnea symptoms.
- 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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Workers in a Barcelona tertiary hospital | – | –Workers attending annual medical checkups |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Workers attending annual checkups at the Hospital's medical department.
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleeping time and sleeping schedules in a working population in a health care environment
Time frame: 4 months
Number of hours of sleep during the working days and during the weekend
3 secondary outcomes
Symptoms compatible with the sleep apnea syndrome
Time frame: 4 months
Analyze predictors of daytime sleepiness
Time frame: 4 months
Frequency of perceived daytime sleepiness
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
- Background: PubMed 15678919Kaneita 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.
- Background: PubMed 16171277Kim 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.
- Background: PubMed 1798888Johns 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.
- Background: PubMed 14555573Netzer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Lloberes, MD,pHD principal investigator
Servei de Pneumologia Hospital Universitari Vall d'Hebron Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Subjective Sleepiness, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleeping time and sleeping schedules in a working population in a health care environment (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01175304, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011.