Mental Health IssueNCT06551428
The Effect of Sleep Quality on Mental and Physical Health
An observational study of Mental Health Issue and Physical Stress, run by Ahmed Ali Mohammed Torad at 2 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 17 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue, Physical Stress
- How many people
- 380 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Feb 2025to 21 Dec 2025
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 17 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: kafrelsheikh university students
Who may be able to join
- -university students between the ages of 18 and 35.
Who cannot join
- 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
Show all 15Show fewer
- Multiple Sclerosis (MS)
- Thyroid Disorders
- Medication:
- Sleep aids
- antidepressants
- diuretics
- antihistamines
- hormonal medications
- blood pressure medications
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516
Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516
Abdelrazek Youssef Desouky, PhD, prof, 002- 047-3109590, president@kfs.edu.eg
Ismail Ismail ElSayed, PhD, prof, +201017524003
About this study
Official title: The Sleep Stress Connection: Investigating How Sleep Quality Affects Mental and Physical Health
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.
Read the detailed description
This study aims 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 key factor in promoting overall well-being.
In conclusion, understanding the intricate relationship between sleep quality, stress, and mental and physical health is vital for promoting holistic well-being, developing effective interventions, and improving health outcomes at individual, community, and societal levels. By recognizing the significance of this research, we can work towards creating a healthier and more resilient population.
- Conditions
- Mental Health Issue, Physical Stress
- Keywords
- Sleep and mental health, Stress-sleep connection, Mental health and sleep, Sleep disorders and health impact, Sleep and stress effects, Sleep impact on Physical health, Sleep quality
- Medical subject headings
- Psychological Well-Being, Sleep Wake Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| university students between age of 15 and 35 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Fatigue
Measurement tool: fatigue assessment scale.
Unit of measurement:
Based on subjective rating"numerical scale"
Measured: Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Feb 2025 (estimated)
- Primary completion20 Oct 2025 (estimated)
- Study completion21 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 380 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Ahmed Ali Mohammed Torad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Ali Mohammed Torad, Kafrelsheikh University
- Investigators
- Ahmed Ali Torad, PhD, lecturer, Principal investigator, Faculty of physical therapy Kafrelsheikh universityTamer Mohamed El-Saeed, PhD, associate professor, Study director, Cairo UniversityReda Fathi Elbosaty, Bachelor student, Principal investigator, Faculty of physical therapy, kafrelsheikh universityNoran Abdallah Essa, Bachelor student, Principal investigator, Faculty of physical therapy, kafrelsheikh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551428
- Sponsor's protocol ID
- KFSIRB200-267
- Status last verified
- Jan 2025
- First submitted
- 9 Aug 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon reasonable request from the principal investigator.
Publications
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.
PubMed 34607184Irish 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.
PubMed 25454674Uccella 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.
PubMed 37190534Sovold 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.
PubMed 34026720
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sleep Stress Connection: Investigating How Sleep Quality Affects Mental and Physical Health
- ClinicalTrials.gov ID
- NCT06551428
- Acronym / sponsor ID
- KFSIRB200-267
- Conditions
- Mental Health Issue, Physical Stress
- Keywords
- Sleep and mental health, Stress-sleep connection, Mental health and sleep, Sleep disorders and health impact, Sleep and stress effects, Sleep impact on Physical health, Sleep quality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Ahmed Ali Mohammed ToradUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 21 Dec 2025 (estimated)
- First posted
- 13 Aug 2024 (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.
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.
Detailed description
This study aims 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 key factor in promoting overall well-being.
In conclusion, understanding the intricate relationship between sleep quality, stress, and mental and physical health is vital for promoting holistic well-being, developing effective interventions, and improving health outcomes at individual, community, and societal levels. By recognizing the significance of this research, we can work towards creating a healthier and more resilient population.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| university students between age of 15 and 35 | – | – |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- kafrelsheikh university students
Key inclusion criteria (1 listed)
- -university students between the ages of 18 and 35.
Key exclusion criteria (15 listed)
- 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:
- Restless Legs Syndrome (RLS)
- Bipolar Disorder
- Fibromyalgia:
- Parkinson's Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stress
Time frame: Week
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.
Sleep quality
Time frame: Week
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.
Mental and physical health
Time frame: 4 weeks
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.
Fatigue
Time frame: Week
Measurement tool: fatigue assessment scale. Unit of measurement: Based on subjective rating"numerical scale"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Background: PubMed 34607184Scott 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.
- Background: PubMed 25454674Irish 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.
- Background: PubMed 37190534Uccella 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.
- Background: PubMed 34026720Sovold 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.
- Individual participant dataSharing planned: Undecided. Data will be shared upon reasonable request from the principal investigator.
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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.
Ahmed Ali Torad, PhD, lecturer principal investigator
Faculty of physical therapy Kafrelsheikh university
Tamer Mohamed El-Saeed, PhD, associate professor study director
Cairo University
Reda Fathi Elbosaty, Bachelor student principal investigator
Faculty of physical therapy, kafrelsheikh 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 Mental Health Issue and Physical Stress, run by Ahmed Ali Mohammed Torad 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 15 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: opening soon, as of the sponsor's last update on 9 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noran Abdallah Essa, Bachelor student (+201069700624, noraneisa36@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress (time frame: Week). 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?
On the ClinicalTrials.gov record for NCT06551428, which also lists 4 linked publications.
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 9 Jan 2025.