Mother-caregivers of Children With Duchenne Muscular Dystrophy

Study Overview
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Brief Summary
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The incidence of Duchenne Muscular Dystrophy (DMD) is approximately 1 in 3.500 male newborns. During its progression there is loss of mobility, swallowing difficulties and a significant reduction in respiratory capacity. Due to the severity and consequences, is inevitable the need for a caregiver, that normally rely the mother.

Detailed Description
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The Duchenne Muscular Dystrophy (DMD) is a neuromuscular disease characterized by genetic alteration, whose consequence is the progression of muscle degeneration. The mother-caregiver dedicates herself entirely to her son, putting aside the care of their physical and psychological health. The responsibility and workload to care for the child is high. Because of this extreme amount of work associated with other factors such as stress, this mothers-caregivers are more likely to develop hypertension, respiratory disease, susceptibility to infections, depression, anxiety, insomnia, impaired immune and cardiovascular problems. Moreover, they are more likely to develop sleep disorders, those who may cause a high health risk, since many sleep disorders are related to cardiovascular, respiratory, neurological and immune systems.

Official Title
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Profile of Mother-caregivers of Children With Duchenne Muscular Dystrophy

Conditions
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Other Diseases or Conditions

Intervention / Treatment
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* Biological: sleep parameters
* Biological: Hormonal profile
* Biological: Inflammatory profile
* Biological: Cardiovascular profile
* Biological: Metabolic profile


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mothers-caregivers of children and adolescents with DMD Mothers of children and adolescents without any neuromuscular disease and that does not have any chronic disease (bronchiolitis obliterates, cystic fibrosis, a genetic syndrome) Exclusion Criteria: Volunteers with low levels of education (voluntary functional illiterate) that prevents the questionnaires and understanding of the guidelines made Working mothers of nocturnal period

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sleep parameters<br>To assess the sleep parameters. | Biological: sleep parameters<br>* Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.<br>|
| Other: cardiovascular parameters<br>To assess the cardiovascular profile of control mothers and caregivers-mothers. | Biological: Cardiovascular profile<br>* To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters<br>* Other names: Creatine kinase MB (CKMB);|
| Experimental: imflammatory and immunological profile<br>To assess the inflammatory profile of caregivers-mothers and control mothers | Biological: Inflammatory profile<br>* To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters<br>* Other names: Lymphocytes subpopulations (T e B);|
| Experimental: hormonal profile<br>To assess the hormonal profile of caregivers-mothers and control mothers. | Biological: Hormonal profile<br>* To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters.<br>* Other names: Adrenocorticotropic hormone (ACTH);|
| Experimental: metabolic profile<br>To assess the health profile of caregivers-mothers and control mothers. | Biological: Metabolic profile<br>* To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters<br>* Other names: Natriuretic Peptide B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sleep patterns of the study population | Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormonal profile | To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters: Insulin Cortisol Luteinizing hormone (LH) Follicle-stimulating hormone (FSH) Total Testosterone Estradiol Progesterone Vitamin B12 Adrenocorticotropic hormone (ACTH) | Baseline | 
| Inflammatory profile | To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters: C-reactive protein (PCR) Immunoglobulin A (IgA) Immunoglobulin G (IgG) Immunoglobulin M (IgM) Complement (C3) Complement (C4) Interleukin 6 Interleukin 10 Interleukin 1β Interleukin 2 Interleukin 4 Interleukin 8 Interferon-gamma (IFN-γ) Endothelin Prostaglandin E2 Intercellular Adhesion Molecule 1 (ICAM) Vascular cell adhesion protein 1 (VCAM) Tumor necrosis factor (TNFα) Adiponectin Leptin Cysteine Lymphocytes subpopulations (T e B) | Baseline | 
| Cardiovascular profile | To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters: Homocysteine Myoglobin Cardiac troponin I Creatine kinase (CK) Creatine kinase MB (CKMB) | Baseline | 
| Metabolic profile | To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters: Glucose Total cholesterol and fractions Triglycerides Uric acid Creatinine Urea Sodium Potassium Hemogram Erythrocyte sedimentation rate Natriuretic Peptide B | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Duchenne;, mothers caregivers;, sleep;, hormonal profile;, cardiac profile;, biochemical profile;, inflammatory profile.