Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-29 @ 7:50 AM
Study NCT ID:
NCT06551428
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-09
First Post:
2024-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sleep Quality on Mental and Physical Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 380}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2024-08-09', 'studyFirstSubmitQcDate': '2024-08-09', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress', 'timeFrame': 'Week', 'description': 'Measurement tool: THE DASS-21 scale\n\nUnit 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\n\nThe 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.'}, {'measure': 'Sleep quality', 'timeFrame': 'Week', 'description': 'Measurement tool:epwoth sleepiness sclae (ESS).\n\nUnit of measurement:\n\nThe \\*\\*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:\n\nThe 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:\n\nThese scores help in identifying individuals who may require further evaluation for sleep disorders.'}, {'measure': 'Mental and physical health', 'timeFrame': '4 weeks', 'description': 'Measurement tool:SF-12 health survey scoring.\n\nUnit of measurement:\n\nThe 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.'}, {'measure': 'Fatigue', 'timeFrame': 'Week', 'description': 'Measurement tool: fatigue assessment scale.\n\nUnit of measurement:\n\nBased on subjective rating"numerical scale"'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Mental Health Issue', 'Physical Stress']}, 'referencesModule': {'references': [{'pmid': '34607184', 'type': 'BACKGROUND', 'citation': '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': '25454674', 'type': 'BACKGROUND', 'citation': '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': '37190534', 'type': 'BACKGROUND', 'citation': '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': '34026720', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to explore the relationship between sleep quality and its impact on mental and physical health, particularly in the context of stress.\n\nA mixed methods approach will be used including:\n\na 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.\n\nAll of that will highlight the importance of addressing sleep quality as a crucial factor in promoting overall well-being.', 'detailedDescription': 'This study aims to explore the relationship between sleep quality and its impact on mental and physical health, particularly in the context of stress.\n\nA 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.\n\nAll of that will highlight the importance of addressing sleep quality as a key factor in promoting overall well-being.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '17 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'kafrelsheikh university students', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n-university students between the ages of 18 and 35.\n\nExclusion Criteria:\n\n* 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:\n\nDiseases and conditions:\n\n* Restless Legs Syndrome (RLS)\n* Bipolar Disorder\n* Fibromyalgia:\n* Parkinson's Disease\n* Multiple Sclerosis (MS)\n* Thyroid Disorders\n\nMedication:\n\n* Sleep aids\n* antidepressants\n* diuretics\n* antihistamines\n* hormonal medications\n* blood pressure medications"}, 'identificationModule': {'nctId': 'NCT06551428', 'briefTitle': 'The Effect of Sleep Quality on Mental and Physical Health', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'The Sleep Stress Connection: Investigating How Sleep Quality Affects Mental and Physical Health', 'orgStudyIdInfo': {'id': 'KFSIRB200-267'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'university students between age of 15 and 35'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33516', 'city': 'Kafr ash Shaykh', 'state': 'Kafr el-Sheikh Governorate', 'country': 'Egypt', 'facility': 'Kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}, {'zip': '33516', 'city': 'Kafr ash Shaykh', 'state': 'Kafr el-Sheikh Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Abdelrazek Youssef Desouky, PhD, prof', 'role': 'CONTACT', 'email': 'president@kfs.edu.eg', 'phone': '002- 047-3109590'}, {'name': 'Ismail Ismail ElSayed, PhD, prof', 'role': 'CONTACT', 'phone': '+201017524003'}], 'facility': 'Kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'centralContacts': [{'name': 'Noran Abdallah Essa, Bachelor student', 'role': 'CONTACT', 'email': 'noraneisa36@gmail.com', 'phone': '+201069700624'}, {'name': 'Reda Fathi Elbosaty, Bachelor student', 'role': 'CONTACT', 'email': 'reda_1661a@pt.kfs.edu.eg', 'phone': '+201555401579'}], 'overallOfficials': [{'name': 'Ahmed Ali Torad, PhD, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of physical therapy Kafrelsheikh university'}, {'name': 'Tamer Mohamed El-Saeed, PhD, associate professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}, {'name': 'Reda Fathi Elbosaty, Bachelor student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of physical therapy, kafrelsheikh university'}, {'name': 'Noran Abdallah Essa, Bachelor student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of physical therapy, kafrelsheikh university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be shared upon reasonable request from the principal investigator.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahmed Ali Mohammed Torad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer at department of the basic sciences', 'investigatorFullName': 'Ahmed Ali Mohammed Torad', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}