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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04716283
Other study ID # soh-Med-21-01-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 15, 2021
Est. completion date October 10, 2022

Study information

Verified date March 2022
Source Sohag University
Contact Dalia S Louis, Demonstrator
Phone +20 01229722449
Email daliasaad.2@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 .


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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 440
Est. completion date October 10, 2022
Est. primary completion date August 26, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria: - students who are in the first four years in the selected faculties . Exclusion Criteria: - students who will refuse to participate in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Egypt Sohag University Sohag
Egypt Sohag University Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. It will be measured after completion of the study ,approximately in october 2022.
Primary 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 . It will be measured after completion of the study ,approximately in octuber 2022.
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