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NCT05359302 Clinical Trial

Effects of Ramadan Fasting on Sleeping and Quality of Life

Quality of Life Clinical Trial

Official title:
Effects of Ramadan Fasting on Sleeping and Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05359302
Other study ID # Sleeping and quality of life
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2022
Est. completion date July 2024

Study information
Verified date November 2023
Source University of Monastir
Contact Semir Nouira, Professor
Phone 7310600
Email semir.nouira@rns.tn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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 .

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date July 2024
Est. primary completion date June 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Tunisia University hospital Fattouma Bourguiba Monastir

Sponsors (1)
Lead Sponsor Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome
Type Measure Description Time frame Safety issue
Primary the change in sleeping quality the score of sleeping is calculated for each participant in the day of inclusion , then it is recalculated in the two others visits. the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan
Primary the change in the quality of life score 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. the day of inclusion , 10 last day of Ramadan , 1 month after Ramadan
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