- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03318302
Sleep and Exposure to Screens of Digital Media Devices in Israel
October 18, 2017 updated by: Lilach Kemer, Assuta Medical Center
University of Haifa
The aims of this survey are to assess the relationships between exposure to screens of digital media devices, sleep patterns, and daily function such as subjective sleepiness and attention abilities in adult Israel population
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Self-reporting questionnaires: demographic, general health, sleep patterns and difficulties, and prevalence and exposure patterns to digital media screens.
- Demographic: the participants report their age, gender, family status, education, and employment status including shift work.
- General health: The subjective general health evaluation was measured with the question "Please rate how do you assess your health condition?" on a 5-point Likert scale with numbers and a description: 1 = "not good," 2 = "fine," 3 = "good," 4 = "very good," and 5 = "excellent." the participants report chronic sickness, prescription and non-prescription medications, height and weight, visual and sight condition ("Do you wear glasses? Do you suffer from cataracts?"). The participants self reports their level of concentration in the morning ("Please rate your level of concentration in the morning.") on a 9-point Likert scale. All of the numbers have valid point values, but only the odd numbers have descriptions: 1 = "extremely poor concentration", 3 = "not able to concentrate," 5 = "neutral, neither unable to concentrate or concentrate," 7 = "able to concentrate," and 9 = "extremely good concentration."
- Sleep: The Pittsburgh Sleep Quality Index (PSQI) was applied to evaluate sleep timing, sleep onset latency, sleep duration, sleep difficulties, and sleep quality. The PSQI is a self-reporting questionnaire that assesses sleep quality over a 1-month time interval. The PSQI consists of 19 individual items comprising seven components that produce one global score. The PSQI is a standardized sleep questionnaire for clinicians and researchers to use with ease and for multiple populations, used in many research and clinical settings to diagnose sleep disorders (Buyess et al., 1989; Shocat et al., 2007). The Karolinska Sleepiness Scale (KSS) was used to assess sleepiness and tiredness. It is a nine-point Likert scale; all of the numbers have valid point values, but only the odd numbers have descriptions: 1 = "extremely alert," 3 = "alert," 5 = "neither alert nor sleepy," 7 = "sleepy," and 9 = "extremely sleepy" (Akerstedt and Gillberg, 1990; Gillberg et al., 1994)
- Exposure to screens of digital media devices: The participants were asked about the presence and usage habits of digital media devices equipped with a screen (for example, TV, computer, tablet, and smartphone) and reported whether they had a TV, computer, tablet, and smartphone in their homes and bedrooms. They reported the duration of exposure time to digital screens of any digital media device for different time-periods of the day beginning in the morning until bedtime or sleep during weekdays and on weekends. We asked the participants to report on their exposure time to screens of digital devices the mean time in minutes of each separate time-period: early morning, before work or school, during work or study time, after work or study, until bedtime, and after bedtime. Digital media usage for all devices (TVs, computers, smartphones, and tablets) were computed for each 4-time periods of the day (sum-morning, Sum-day, sum-evening, and sum-night) reflecting the summation time in minutes to overall exposure time of digital media screens devices in each time segment of the day.
Study Type
Observational
Enrollment (Actual)
282
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Haifa, Israel
- University of Haifa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult population of Isrel
Description
Inclusion Criteria:
- All of the participants were Hebrew-speaking residents of Israel
Exclusion Criteria:
- under 18 years old No Hebrew-speaking residents of Israel
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sleep quality
Time Frame: 30 days
|
score on the PSQI questionnaire
|
30 days
|
|
subjective sleepiness
Time Frame: 30 days
|
score on the KSS questionnaire
|
30 days
|
|
subjective concentration score
Time Frame: 30 days
|
score on the concentration questionnaire
|
30 days
|
|
exposure time to digital screen
Time Frame: 30 days
|
The exposure time to digital screens in minutes
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lilach Kemer, Dr., Assuta Medial Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
June 30, 2017
Study Completion (Actual)
June 30, 2017
Study Registration Dates
First Submitted
October 14, 2017
First Submitted That Met QC Criteria
October 18, 2017
First Posted (Actual)
October 23, 2017
Study Record Updates
Last Update Posted (Actual)
October 23, 2017
Last Update Submitted That Met QC Criteria
October 18, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 039/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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