Other Diseases or Conditions
Conditions
Keywords
Duchenne;, mothers caregivers;, sleep;, hormonal profile;, cardiac profile;, biochemical profile;, inflammatory profile.
Brief summary
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
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.
Interventions
BIOLOGICALsleep parameters
Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.
BIOLOGICALHormonal 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.
BIOLOGICALInflammatory 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
BIOLOGICALCardiovascular 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
BIOLOGICALMetabolic 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
Sponsors
Monica Levy Andersen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sleep patterns of the study population | Baseline | Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hormonal profile | Baseline | 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) |
| Inflammatory profile | Baseline | 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) |
| Cardiovascular profile | Baseline | 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) |
| Metabolic profile | Baseline | 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 |
Countries
Brazil
Outcome results
None listed