Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT05359302
Status:
COMPLETED
Last Update Posted:
2025-01-15
First Post:
2022-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Ramadan Fasting on Sleeping and Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'targetDuration': '12 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2022-04-22', 'studyFirstSubmitQcDate': '2022-04-28', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change in sleeping quality', 'timeFrame': 'the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan', 'description': 'the score of sleeping is calculated for each participant in the day of inclusion , then it is recalculated in the two others visits.'}, {'measure': 'the change in the quality of life score', 'timeFrame': 'the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan', 'description': 'the score of quality of life is calculated for each participant in the day of inclusion , then it is recalculated in the two others visits.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ramadan Fasting', 'SF-36 score', 'sleeping score'], 'conditions': ['Fasting', 'Quality of Life', 'Sleep Disorder']}, 'descriptionModule': {'briefSummary': 'Include participants who intend to practice Ramadan fasting and accept to complete the three part of the study .', 'detailedDescription': 'All volunteers and stable patients that intend to fast ramadan. Each participant is examined during three separate visits.\n\nThe week before Ramadan (Pre-R). the last week of Ramadan (R). the last week of the month following Ramadan (Post-R). Participants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patients clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.\n\nAll patients benifit of a routine examen and evaluation of the quality of life by Short Form 36 (SF36) test and sleeping by Pittsburg Sleep Quality Index (PQSI) score .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stable patients that intend to fast Ramadan. Each participant is examined during three planned visits. The first takes place during the month preceding Ramadan. The second during the last week of Ramadan and the third thirty days after the end of Ramadan.\n\nParticipants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patient clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient intending to fast Ramadan.\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Hemodynamic instability.\n* Myocardial infarction requiring urgent revascularization.\n* Parkinsonism: tremor problem.\n* Refusal, communication problem.'}, 'identificationModule': {'nctId': 'NCT05359302', 'briefTitle': 'Effects of Ramadan Fasting on Sleeping and Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Effects of Ramadan Fasting on Sleeping and Quality of Life', 'orgStudyIdInfo': {'id': 'Sleeping and quality of life'}}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'country': 'Tunisia', 'facility': 'University hospital Fattouma Bourguiba', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'overallOfficials': [{'name': 'Semir Nouira', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Monastir'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chef of Emergency Deparment', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}