NCT05359302

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 22, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

April 22, 2022

Last Update Submit

January 13, 2025

Conditions

Keywords

Ramadan FastingSF-36 scoresleeping score

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Adult patient intending to fast Ramadan.

You may not qualify if:

  • Age \< 18 years old
  • Hemodynamic instability.
  • Myocardial infarction requiring urgent revascularization.
  • Parkinsonism: tremor problem.
  • Refusal, communication problem.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Fattouma Bourguiba

Monastir, 5000, Tunisia

Location

MeSH Terms

Conditions

FastingSleep Wake Disorders

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Semir Nouira

    University of Monastir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chef of Emergency Deparment

Study Record Dates

First Submitted

April 22, 2022

First Posted

May 3, 2022

Study Start

March 15, 2022

Primary Completion

June 15, 2023

Study Completion

July 31, 2023

Last Updated

January 15, 2025

Record last verified: 2025-01

Locations