NCT06551428

Brief Summary

This study aimed to explore the relationship between sleep quality and its impact on mental and physical health, particularly in the context of stress. A mixed methods approach will be used including: a pre-test questionnaire and physiological measurements that depend on scales for measuring to assess sleep patterns: DASS21, fatigue assessment scale, Epworth sleeping scale, and SF-12 health survey scoring. All of that will highlight the importance of addressing sleep quality as a crucial factor in promoting overall well-being.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2025

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

9 months

First QC Date

August 9, 2024

Last Update Submit

January 7, 2025

Conditions

Keywords

Sleep and mental healthStress-sleep connectionMental health and sleepSleep disorders and health impactSleep and stress effectsSleep impact on Physical healthSleep quality

Outcome Measures

Primary Outcomes (4)

  • Stress

    Measurement tool: THE DASS-21 scale Unit of measurement:The DASS-21 (Depression, Anxiety, and Stress Scale - 21 items) measures psychological distress across three domains: depression, anxiety, and stress. Each of the three scales consists of 7 items, and respondents rate their experience over the past week on a 4-point Likert scale The scores for each domain are summed to provide a total score, which can then be categorized into different severity levels (normal, mild, moderate, severe, and extremely severe) based on specific cutoff points. Each of the three domains is measured separately, and the resulting scores are typically reported as a total score for each domain.

    Week

  • Sleep quality

    Measurement tool:epwoth sleepiness sclae (ESS). Unit of measurement: The \*\*Epworth Sleepiness Scale (ESS)\*\* is used to assess daytime sleepiness. It consists of 8 scenarios, and respondents rate their likelihood of dozing off in each situation on a scale from 0 to 3: The total score is obtained by summing the scores for all 8 items, resulting in a score that can range from \*\*0 to 24\*\*. Higher scores indicate greater levels of daytime sleepiness. The following cutoff values are often used to interpret the results: These scores help in identifying individuals who may require further evaluation for sleep disorders.

    Week

  • Mental and physical health

    Measurement tool:SF-12 health survey scoring. Unit of measurement: The SF-12 health survey scoring uses a unitless scale to measure health-related quality of life. The scores range from 0 to 100, with higher scores indicating better health status. The survey assesses physical and mental health across various dimensions but does not assign specific units of measurement like inches or pounds; instead, it provides a standardized score reflecting overall health.

    4 weeks

  • Fatigue

    Measurement tool: fatigue assessment scale. Unit of measurement: Based on subjective rating"numerical scale"

    Week

Study Arms (1)

university students between age of 15 and 35

Eligibility Criteria

Age17 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

kafrelsheikh university students

You may qualify if:

  • university students between the ages of 18 and 35.

You may not qualify if:

  • People with diseases and conditions can significantly affect sleep quality, cause fatigue, and impact mental and physical health along with relevant medications that might exacerbate these issues:
  • Diseases and conditions:
  • Restless Legs Syndrome (RLS)
  • Bipolar Disorder
  • Fibromyalgia:
  • Parkinson's Disease
  • Multiple Sclerosis (MS)
  • Thyroid Disorders
  • Medication:
  • Sleep aids
  • antidepressants
  • diuretics
  • antihistamines
  • hormonal medications
  • blood pressure medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt

Location

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt

Location

Related Publications (4)

  • Scott AJ, Webb TL, Martyn-St James M, Rowse G, Weich S. Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials. Sleep Med Rev. 2021 Dec;60:101556. doi: 10.1016/j.smrv.2021.101556. Epub 2021 Sep 23.

    PMID: 34607184BACKGROUND
  • Irish LA, Kline CE, Gunn HE, Buysse DJ, Hall MH. The role of sleep hygiene in promoting public health: A review of empirical evidence. Sleep Med Rev. 2015 Aug;22:23-36. doi: 10.1016/j.smrv.2014.10.001. Epub 2014 Oct 16.

    PMID: 25454674BACKGROUND
  • Uccella S, Cordani R, Salfi F, Gorgoni M, Scarpelli S, Gemignani A, Geoffroy PA, De Gennaro L, Palagini L, Ferrara M, Nobili L. Sleep Deprivation and Insomnia in Adolescence: Implications for Mental Health. Brain Sci. 2023 Mar 28;13(4):569. doi: 10.3390/brainsci13040569.

    PMID: 37190534BACKGROUND
  • Sovold LE, Naslund JA, Kousoulis AA, Saxena S, Qoronfleh MW, Grobler C, Munter L. Prioritizing the Mental Health and Well-Being of Healthcare Workers: An Urgent Global Public Health Priority. Front Public Health. 2021 May 7;9:679397. doi: 10.3389/fpubh.2021.679397. eCollection 2021.

    PMID: 34026720BACKGROUND

MeSH Terms

Conditions

Psychological Well-BeingSleep Wake DisordersSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSleep Disorders, IntrinsicDyssomnias

Study Officials

  • Ahmed Ali Torad, PhD, lecturer

    Faculty of physical therapy Kafrelsheikh university

    PRINCIPAL INVESTIGATOR
  • Tamer Mohamed El-Saeed, PhD, associate professor

    Cairo University

    STUDY DIRECTOR
  • Reda Fathi Elbosaty, Bachelor student

    Faculty of physical therapy, kafrelsheikh university

    PRINCIPAL INVESTIGATOR
  • Noran Abdallah Essa, Bachelor student

    Faculty of physical therapy, kafrelsheikh university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noran Abdallah Essa, Bachelor student

CONTACT

Reda Fathi Elbosaty, Bachelor student

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer at department of the basic sciences

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 13, 2024

Study Start

February 1, 2025

Primary Completion

October 20, 2025

Study Completion

December 21, 2025

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations