Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04835298
Status:
COMPLETED
Last Update Posted:
2022-06-15
First Post:
2021-03-31
Brief Title:
Breathlessness Assessment in Adult Patients With Myotonic Dystrophy Type 1
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Characters Dyspnea Assessment in Adult Patients With Myotonic Dystrophy Type 1 a Monocentric Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Myotonic dystrophy type 1 DM1 is one of the most common neuromuscular diseases in adults As respiratory dysfunction is the most common cause of death in patients with DM1 a respiratory disease progression must be monitored combining symptom screening and respiratory function testing in order to identify the appropriate time to initiate non invasive ventilation NIV
Dyspnea one of the main respiratory symptoms has been little studied in patients with DM1
The main objective of this study is to provide the first multidimensional description of dyspnea in patients with DM1
The secondary objectives are
To compare respiratory symptoms according to the presence or not of criteria from respiratory function testing to initiate NIV
To assess associations between dyspnea and respiratory function testing
To assess associations between dyspnea and number of Cytosine Thymine Guanine CTG repeats
To assess associations between dyspnea and muscular strength
To assess associations between dyspnea and BMI
To assess associations between dyspnea and anxiety or depression
To assess associations between dyspnea and cognitive impairment
To assess associations between dyspnea and quality of life
Dyspnea one of the main respiratory symptoms has been little studied in patients with DM1
The main objective of this study is to provide the first multidimensional description of dyspnea in patients with DM1
The secondary objectives are
To compare respiratory symptoms according to the presence or not of criteria from respiratory function testing to initiate NIV
To assess associations between dyspnea and respiratory function testing
To assess associations between dyspnea and number of Cytosine Thymine Guanine CTG repeats
To assess associations between dyspnea and muscular strength
To assess associations between dyspnea and BMI
To assess associations between dyspnea and anxiety or depression
To assess associations between dyspnea and cognitive impairment
To assess associations between dyspnea and quality of life
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None