Effect of MYODM on Quality of Life, Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1
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|ClinicalTrials.gov Identifier: NCT04634682|
Recruitment Status : Recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Myotonic Dystrophy 1||Dietary Supplement: MYODM||Not Applicable|
Myotonic Dystrophy type I (DM1) is the most common form of adult muscular dystrophy, affecting 1 in 8000 individuals. It is an autosomal dominant disorder with multisystemic involvement of multiple organs and tissues, mainly brain, heart, endocrine system, eyes and both smooth and skeletal muscles.
Hypersomnolence is one of the most frequently reported symptoms in patients with DM1 and often lead to handicap such as cessation of employment and withdrawal from social activities. The present project is a 6 month randomized study to assess the effect of MYODM on fatigue, hypersomnia and quality of life in DM1 patients.The patients will be randomized to one of the two study arms. The active arm will receive the MYODM treatment and the control arm will not but both will follow the same evaluation program.
Patients will come to the center every 3 months for evaluations.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Assessing the Effect of the MYODM Food Supplement on Quality of Life, Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1|
|Actual Study Start Date :||November 9, 2020|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||September 2021|
MYODM, three times a day, orally
Dietary Supplement: MYODM
Formulated composition containing Theobroma cacao supplemented with caffeine
No Intervention: No intervention
Patients will follow the same evaluation schedule but will not receive MYODM
- Change in Individualized Neuromuscular Quality of Life (INQoL) Mean Scores [ Time Frame: Screening, Month 3, Month 6 ]Scores from the self-administered INQoL questionnaire will be compared at the start of the study (Month 0) and at the end (Month 6) among the MYODM treated group and the control group. Scores range from 0-100, with 100 being a better outcome.
- Change in Individualized Short Form-36 (SF-36) Mean Scores [ Time Frame: Screening, Month 3, Month 6 ]Scores from the self-administered SF-36 questionnaire will be measured at the start of the study (Month 0), and at the end (Month 6) among patients in the MYODM-treated group and control group. Mean scores range from 0 (minimum) - 100 (maximum) with higher mean scores reflecting better outcomes.
- Change in Epworth Sleepiness Scale (ESS) Scores [ Time Frame: Screening, Month 3, Month 6 ]ESS score range is 0-24; lower ESS scores indicate less daytime sleepiness; higher ESS scores indicate more severe sleepiness
- Change in Physical activity and daytime sleepiness measured with GeneActiv actometer [ Time Frame: Screening, Baseline, Month 6 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04634682
|Hospital Universitario Donostia||Recruiting|
|San Sebastián, Guipuzkoa, Spain, 20014|
|Contact: Roberto Fernandez Torron 943 00 70 27 firstname.lastname@example.org|