Effects of Ramadan Fasting on Sleeping and Quality of Life

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Sleep Disorder; Fasting

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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • University hospital Fattouma Bourguiba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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.

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-patient clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Principal Investigator: Semir Nouira, University of Monastir

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Ramadan Fasting; SF-36 score; sleeping score
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Sleep Wake Disorders
• Other Study ID Numbers: Sleeping and quality of life

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No