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.
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.
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.
- 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.
- Conditions
- Sleep Disturbance, Attention Deficit
- 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.
sleep quality
score on the PSQI questionnaire
Measured: 30 days
subjective sleepiness
score on the KSS questionnaire
Measured: 30 days
subjective concentration score
score on the concentration questionnaire
Measured: 30 days
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.
- First posted23 Oct 2017
- Study start1 Feb 2017
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilach Kemer, Assuta Medical Center
- Investigators
- Lilach Kemer, Dr., Principal investigator, Assuta Medial Center
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Haifa
- ClinicalTrials.gov ID
- NCT03318302
- Acronym / sponsor ID
- 039/17
- Conditions
- Sleep Disturbance, Attention Deficit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 23 Oct 2017 (actual)
- 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 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
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 design
- Observational model
- Ecologic or community
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population of Isrel
Key inclusion criteria (1 listed)
- All of the participants were Hebrew-speaking residents of Israel
Key exclusion criteria (1 listed)
- under 18 years old No Hebrew-speaking residents of Israel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyAlso: Survey of the adult population in IsraelSurvey of the adult population in Israel | Other | – |
Primary outcome
sleep quality
Time frame: 30 days
score on the PSQI questionnaire
subjective sleepiness
Time frame: 30 days
score on the KSS questionnaire
subjective concentration score
Time frame: 30 days
score on the concentration questionnaire
exposure time to digital screen
Time frame: 30 days
The exposure time to digital screens in minutes
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 23 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Lilach Kemer, Dr. principal investigator
Assuta Medial Center
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 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.