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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Self-reporting questionnaires: demographic, general health, sleep patterns and difficulties, and prevalence and exposure patterns to digital media screens.

  1. Demographic: the participants report their age, gender, family status, education, and employment status including shift work.
  2. 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."
  3. 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)
  4. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Israel
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assuta Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Sleep Disturbance

Clinical Trials on Survey

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings