Fatigue, Depressive Disorders and Insomnia in Adult Patients With Marfan Syndrome and Ehlers-Danlos Syndrome: Survey

Depression Clinical Trial

— FAMED  

Official title:

Observational Survey on Fatigue Levels in Relation to Depressive Disorders and Insomnia in Adult Patients With Marfan Syndrome and Ehlers-Danlos Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05712564
• Other study ID #: FAMED
• Status: Completed
• Start date: January 9, 2023
• Est. completion date: May 9, 2023

Study information

• Verified date: January 2024
• Source: IRCCS Policlinico S. Donato
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to describe and assess the presence of perceived fatigue in subjects with MFS and EDS. the main question it aims to answer through the FSS instrument is:

• The relationship of fatigue with physical and psychological characteristics, the presence of depressive disorders and insomnia.

Description:

Marfan syndrome (MFS) and Ehlers-Danlos Syndrome (EDS) are rare diseases of the connective tissue presenting peculiar symptoms as well as high mortality due to complications related to dilatation and dissection of the ascending aorta and great arteries. Life expectancy of patients with MFS and EDS has improved markedly in the last decades, but still remains lower than that of the general population. Fatigue represent one of the main causes that limit the quality of life in these populations. The Fatigue Severity Scale (FSS) is a questionnaire widely used in populations with chronic diseases and has been previously applied in MFS and EDS population: indeed, fatigue interferes with activities of daily living and the presence of chronic pain. However, the potential correlations that fatigue may have with different aspects of psychological well-being (i.e. insomnia and depression) were not investigated in MFS and EDS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 9, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects aged 18 or greater with clinical and/or genetic diagnosis of Marfan syndrome;

• Subjects aged 18 or greater with clinical and/or genetic diagnosis of Ehlers-Danlos syndrome;

• Signed informed consent.

Exclusion Criteria:

• Functional physical limitations (handicap, impairment, disability) to activities of daily living;

• Clinically significant heart or lung diseases.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Ehlers-Danlos Syndrome
• Fatigue
• Insomnia
• Marfan Syndrome
• Rare Diseases
• Sleep Initiation and Maintenance Disorders
• Syndrome

Intervention

Other:
• Questionnaire
Questionnaire for fatigue assessment

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	San Donato Milanese	Lombardia

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical and psychological features	The mean, median, standard deviation and interquartile range will be used for continuous variables, whereas frequency and percentage will be applied for nominal and categorical variables. The Shapiro-Wilks test will be used to assess the Gaussian distributions.	10 months
Secondary	Psychosocial variables	The bivariate correlation analysis will be performed by calculating the Pearson or Spearman correlation coefficient	10 months