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Effects of Ramadan Fasting on Sleeping and Quality of Life

Sponsor
University of Monastir (Other)
Overall Status
Recruiting
CT.gov ID
NCT05359302
Collaborator
(none)
500
Enrollment
1
Location
10.6
Anticipated Duration (Months)
47.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Include participants who intend to practice Ramadan fasting and accept to complete the three part of the study .

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All volunteers and stable patients that intend to fast ramadan. Each participant is examined during three separate visits.

    The 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.

    All 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 .

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effects of Ramadan Fasting on Sleeping and Quality of Life
    Actual Study Start Date :
    Mar 15, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Feb 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. the change in sleeping quality [the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan]

      the score of sleeping is calculated for each participant in the day of inclusion , then it is recalculated in the two others visits.

    2. the change in the quality of life score [the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Adult patient intending to fast Ramadan.
    Exclusion Criteria:

    • Age < 18 years old

    • Hemodynamic instability.

    • Myocardial infarction requiring urgent revascularization.

    • Parkinsonism: tremor problem.

    • Refusal, communication problem.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital Fattouma Bourguiba Monastir Tunisia 5000

    Sponsors and Collaborators

    • University of Monastir

    Investigators

    • Principal Investigator: Semir Nouira, University of Monastir

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pr. Semir Nouira, Chef of Emergency Deparment, University of Monastir
    ClinicalTrials.gov Identifier:
    NCT05359302
    Other Study ID Numbers:
    • Sleeping and quality of life
    First Posted:
    May 3, 2022
    Last Update Posted:
    Aug 17, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pr. Semir Nouira, Chef of Emergency Deparment, University of Monastir
    Ramadan Fasting
    SF-36 score
    sleeping score
    Additional relevant MeSH terms:
    Sleep Wake Disorders

    Study Results

    No Results Posted as of Aug 17, 2022