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Sleep DisturbanceNCT03318302

Sleep and Exposure to Screens of Digital Media Devices in Israel

An observational study of Sleep Disturbance and Attention Deficit, run by Assuta Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Sleep Disturbance, Attention Deficit
What is being tested?
Survey
How many people
282 participants
Where
1 siteIsrael
Study dates
1 Feb 2017to 30 Jun 2017
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Adult population of Isrel

Who may be able to join

  • All of the participants were Hebrew-speaking residents of Israel

Who cannot join

  • under 18 years old No Hebrew-speaking residents of Israel

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • University of Haifa

    Haifa

Other trials in Israel

About this study

Official title: 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

Read the 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.
Being tested
Survey
Medical subject headings
Parasomnias, Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurveyOther

    Also called Survey of the adult population in Israel

    Survey of the adult population in Israel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. sleep quality

    score on the PSQI questionnaire

    Measured: 30 days

  2. subjective sleepiness

    score on the KSS questionnaire

    Measured: 30 days

  3. subjective concentration score

    score on the concentration questionnaire

    Measured: 30 days

  4. exposure time to digital screen

    The exposure time to digital screens in minutes

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2017
  2. Study start1 Feb 2017
  3. Primary completion30 Jun 2017
  4. Study completion30 Jun 2017

Resources

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
Other
Enrolment
282 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03318302
Sponsor's protocol ID
039/17
Status last verified
Oct 2017
First submitted
14 Oct 2017
Last updated
23 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Disturbance and Attention Deficit, run by Assuta Medical Center at 1 site in Israel.

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 23 Oct 2017. 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 Israel. 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?

sleep quality (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Oct 2017.

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