SleepNCT04716283
Sleep Quality Among Students in Sohag University.
An observational study of Sleep, run by Sohag University at 2 sites in Egypt.
Trial summary
The study will be done among undergraduate students in Sohag University for assessment of quality of sleep and its determinants .It will be done in practical faculties and theoretical faculties . Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Validated questionnaire : The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS)
- How many people
- 440 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Aug 2021to 10 Oct 2022
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study will be conducted in Sohag University where there are ten practical faculties and six theoretical faculties . Two medical faculties and two non medical faculties were chosen randomly to be the setting of the study.
Who may be able to join
- students who are in the first four years in the selected faculties .
Who cannot join
- students who will refuse to participate in this study.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Sohag University
Sohag, 82524
Dalia S Louis, Demonstrator, +201229722449, daliasaad.2@med.sohag.edu
Nesreen A Mohammed, Lecturer, +21017617763, nesreen2025@yahoo.com
- Recruiting
Sohag University
Sohag, Sohag University82524
Dalia S Louis, Demonstrator, +201229722449, daliasaad.2@med.sohag.edu
Nesreen A Mohammed, Lecturer, +21017617763, nesreen2025@yahoo.com
About this study
Official title: Sleep Quality and Its Determinants Among Students in Sohag University.
The study will be done among undergraduate students in Sohag University for assessment of quality of sleep and its determinants .It will be done in practical faculties and theoretical faculties .
Read the detailed description
Sleep is very necessary to our physical and mental health. Sleep is classified into satisfactory and unsatisfactory sleep. Good sleep is sleep which is sufficient in duration and has a good quality while bad sleep is the sleep which makes individual feels unsatisfactory .
University students are exposed to poor sleep, due to high work and study loads. Poor quality sleep has negative consequences on the daily life activities , associated with memory reduction , reduced learning abilities which ultimately can lead to reduce their academic achievements, and can also trigger negative health outcomes, such as mood disturbance, fatigue, impaired concentration .
- Conditions
- Sleep
- Being tested
- Validated questionnaire : The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validated questionnaire : The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS)Other
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score.
The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness .The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index [PSQI]
A questionnaire will be used to measure sleep quality over the last 1 month .The self-related questions include the assessment of seven different sleep domains : sleep quality, sleep latency , sleep duration , habitual sleep efficiency, sleep disturbances , use of sleeping medications , and daytime dysfunction .The seven components scores are then added to yield a global PSQI score in the range of zero to 21. The higher the score, the worse the sleep quality. A global score greater than five is diagnostic of poor sleep quality.
Measured: It will be measured after completion of the study ,approximately in october 2022.
Epworth Sleepiness Scale [ESS]
A questionnaire will be used to measure daytime sleepiness .It can determine the chance of falling asleep in 8 different circumstances. ESS score can range from 0 to 24. A global score greater than ten is diagnostic of excessive daytime sleepiness .
Measured: It will be measured after completion of the study ,approximately in octuber 2022.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start15 Aug 2021
- Primary completion26 Aug 2022 (estimated)
- Study completion10 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia Saad Louis, Sohag University
- Investigators
- Dalia S Louis, Demonstrator, Principal investigator, Faculty of Medicine -Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04716283
- Sponsor's protocol ID
- soh-Med-21-01-01
- Status last verified
- Mar 2022
- First submitted
- 14 Jan 2021
- Last updated
- 20 Jul 2022
- Results posted
- 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 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality and Its Determinants Among Students in Sohag University.
- ClinicalTrials.gov ID
- NCT04716283
- Acronym / sponsor ID
- soh-Med-21-01-01
- Conditions
- Sleep
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 26 Aug 2022 (estimated)
- Study completion
- 10 Oct 2022 (estimated)
- First posted
- 20 Jan 2021 (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 study will be done among undergraduate students in Sohag University for assessment of quality of sleep and its determinants .It will be done in practical faculties and theoretical faculties .
Detailed description
Sleep is very necessary to our physical and mental health. Sleep is classified into satisfactory and unsatisfactory sleep. Good sleep is sleep which is sufficient in duration and has a good quality while bad sleep is the sleep which makes individual feels unsatisfactory .
University students are exposed to poor sleep, due to high work and study loads. Poor quality sleep has negative consequences on the daily life activities , associated with memory reduction , reduced learning abilities which ultimately can lead to reduce their academic achievements, and can also trigger negative health outcomes, such as mood disturbance, fatigue, impaired concentration .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will be conducted in Sohag University where there are ten practical faculties and six theoretical faculties . Two medical faculties and two non medical faculties were chosen randomly to be the setting of the study.
Key inclusion criteria (1 listed)
- students who are in the first four years in the selected faculties .
Key exclusion criteria (1 listed)
- students who will refuse to participate in this study.
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 |
|---|---|---|
| Validated questionnaire : The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS)The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness .The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. | Other | – |
Primary outcome
Pittsburgh Sleep Quality Index [PSQI]
Time frame: It will be measured after completion of the study ,approximately in october 2022.
A questionnaire will be used to measure sleep quality over the last 1 month .The self-related questions include the assessment of seven different sleep domains : sleep quality, sleep latency , sleep duration , habitual sleep efficiency, sleep disturbances , use of sleeping medications , and daytime dysfunction .The seven components scores are then added to yield a global PSQI score in the range of zero to 21. The higher the score, the worse the sleep quality. A global score greater than five is diagnostic of poor sleep quality.
Epworth Sleepiness Scale [ESS]
Time frame: It will be measured after completion of the study ,approximately in octuber 2022.
A questionnaire will be used to measure daytime sleepiness .It can determine the chance of falling asleep in 8 different circumstances. ESS score can range from 0 to 24. A global score greater than ten is diagnostic of excessive daytime sleepiness .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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.
Dalia S Louis, Demonstrator principal investigator
Faculty of Medicine -Sohag University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep, run by Sohag University at 2 sites in Egypt.
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: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia S Louis, Demonstrator (+20 01229722449, daliasaad.2@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index [PSQI] (time frame: It will be measured after completion of the study ,approximately in october 2022.). The study lists 2 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 20 Jul 2022.