Other Diseases or ConditionsDMDKNCT01921374
Mother-caregivers of Children With Duchenne Muscular Dystrophy
A study testing sleep parameters, Hormonal profile and Inflammatory profile in people with Other Diseases or Conditions, run by Monica Levy Andersen at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Other Diseases or Conditions
- What is being tested?
- sleep parameters, Hormonal profile and Inflammatory profile
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Volunteers with low levels of education (voluntary functional illiterate) that prevents the questionnaires and understanding of the guidelines made
- Working mothers of nocturnal period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Profile of Mother-caregivers of Children With Duchenne Muscular Dystrophy
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.
Read the 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.
- Conditions
- Other Diseases or Conditions
- Being tested
- sleep parameters, Hormonal profile, Inflammatory profile, Cardiovascular profile, Metabolic profile
- Keywords
- Duchenne;, mothers caregivers;, sleep;, hormonal profile;, cardiac profile;, biochemical profile;, inflammatory profile.
- Medical subject headings
- Muscular Dystrophy, Duchenne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep parametersBiological
Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.
Hormonal profileBiological
Also called Insulin, Cortisol, Luteinizing hormone (LH), Follicle-stimulating hormone (FSH)
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.
Inflammatory profileBiological
Also called C-reactive protein (PCR), Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM)
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
Cardiovascular profileBiological
Also called Homocysteine, Myoglobin, Cardiac troponin I, Creatine kinase (CK)
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
Metabolic profileBiological
Also called Glucose, Total cholesterol and fractions, Triglycerides, Uric acid
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
| Study group | Role | What they receive |
|---|---|---|
| sleep parameters | Experimental | To assess the sleep parameters. Receives: Biological: sleep parameters |
| cardiovascular parameters | Other | To assess the cardiovascular profile of control mothers and caregivers-mothers. Receives: Biological: Cardiovascular profile |
| imflammatory and immunological profile | Experimental | To assess the inflammatory profile of caregivers-mothers and control mothers Receives: Biological: Inflammatory profile |
| hormonal profile | Experimental | To assess the hormonal profile of caregivers-mothers and control mothers. Receives: Biological: Hormonal profile |
| metabolic profile | Experimental | To assess the health profile of caregivers-mothers and control mothers. Receives: Biological: Metabolic profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Other Diseases or ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monica Levy Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Monica Levy Andersen, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921374
- Sponsor's protocol ID
- DMDK
- Acronym
- DMDK
- Status last verified
- Feb 2016
- First submitted
- 8 Aug 2013
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Donders J, Taneja C. Neurobehavioral characteristics of children with Duchenne muscular dystrophy. Child Neuropsychol. 2009 May;15(3):295-304. doi: 10.1080/09297040802665777. Epub 2009 Jan 22.
PubMed 19160150Draper BM, Poulos CJ, Cole AM, Poulos RG, Ehrlich F. A comparison of caregivers for elderly stroke and dementia victims. J Am Geriatr Soc. 1992 Sep;40(9):896-901. doi: 10.1111/j.1532-5415.1992.tb01986.x.
PubMed 1512385Fee RJ, Hinton VJ. Resilience in children diagnosed with a chronic neuromuscular disorder. J Dev Behav Pediatr. 2011 Nov;32(9):644-50. doi: 10.1097/DBP.0b013e318235d614.
PubMed 22008789
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profile of Mother-caregivers of Children With Duchenne Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT01921374
- Acronym / sponsor ID
- DMDK / DMDK
- Conditions
- Other Diseases or Conditions
- Keywords
- Duchenne;, mothers caregivers;, sleep;, hormonal profile;, cardiac profile;, biochemical profile;, inflammatory profile.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Monica Levy AndersenUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| sleep parameters | Experimental | Biological: sleep parametersTo assess the sleep parameters. |
| cardiovascular parameters | Other | Biological: Cardiovascular profileTo assess the cardiovascular profile of control mothers and caregivers-mothers. |
| imflammatory and immunological profile | Experimental | Biological: Inflammatory profileTo assess the inflammatory profile of caregivers-mothers and control mothers |
| hormonal profile | Experimental | Biological: Hormonal profileTo assess the hormonal profile of caregivers-mothers and control mothers. |
| metabolic profile | Experimental | Biological: Metabolic profileTo assess the health profile of caregivers-mothers and control mothers. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Volunteers with low levels of education (voluntary functional illiterate) that prevents the questionnaires and understanding of the guidelines made
- Working mothers of nocturnal period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleep parametersSince the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern. | Biological | sleep parameters |
| Hormonal profileAlso: Insulin, Cortisol, Luteinizing hormone (LH), Follicle-stimulating hormone (FSH)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. | Biological | hormonal profile |
| Inflammatory profileAlso: C-reactive protein (PCR), Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM)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 | Biological | imflammatory and immunological profile |
| Cardiovascular profileAlso: Homocysteine, Myoglobin, Cardiac troponin I, Creatine kinase (CK)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 | Biological | cardiovascular parameters |
| Metabolic profileAlso: Glucose, Total cholesterol and fractions, Triglycerides, Uric acidTo 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 | Biological | metabolic profile |
Primary outcome
sleep patterns of the study population
Time frame: Baseline
Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.
4 secondary outcomes
Hormonal profile
Time frame: Baseline
Inflammatory profile
Time frame: Baseline
Cardiovascular profile
Time frame: Baseline
Metabolic profile
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Background: PubMed 19160150Donders J, Taneja C. Neurobehavioral characteristics of children with Duchenne muscular dystrophy. Child Neuropsychol. 2009 May;15(3):295-304. doi: 10.1080/09297040802665777. Epub 2009 Jan 22.
- Background: PubMed 1512385Draper BM, Poulos CJ, Cole AM, Poulos RG, Ehrlich F. A comparison of caregivers for elderly stroke and dementia victims. J Am Geriatr Soc. 1992 Sep;40(9):896-901. doi: 10.1111/j.1532-5415.1992.tb01986.x.
- Background: PubMed 22008789Fee RJ, Hinton VJ. Resilience in children diagnosed with a chronic neuromuscular disorder. J Dev Behav Pediatr. 2011 Nov;32(9):644-50. doi: 10.1097/DBP.0b013e318235d614.
- Sleep research societyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sleep parameters, Hormonal profile and Inflammatory profile in people with Other Diseases or Conditions, run by Monica Levy Andersen at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep patterns of the study population (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01921374, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.