Effect of MYODM on Quality of Life, Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1

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Brief Title

Effect of MYODM on Quality of Life, Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1

Official Title

Assessing the Effect of the MYODM Food Supplement on Quality of Life, Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1

Brief Summary

      The purpose of this study is to determine whether MYODM (formulated composition containing
      Theobroma cacao supplemented with caffeine (caffeine/theobromine ratio1/1.85, w/w) is
      effective in the treatment of excessive daytime sleepiness due to myotonic dystrophy type 1
      (DM1) and improves the quality of life of these patients.
    

Detailed Description

      Detailed Description:

      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


Primary Outcome

Change in Individualized Neuromuscular Quality of Life (INQoL) Mean Scores

Secondary Outcome

 Change in Physical activity and daytime sleepiness measured with GeneActiv actometer

Condition

Myotonic Dystrophy 1

Intervention

MYODM

Study Arms / Comparison Groups

 MYODM
Description:  MYODM, three times a day, orally

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

30

Start Date

November 9, 2020

Completion Date

December 3, 2021

Primary Completion Date

November 15, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Able to provide informed consent

          -  Genetically proven DM1

          -  Able to walk independently

        Exclusion Criteria:

          -  Regular intake of plant stanols or other nutritional supplement

          -  Co-morbidity interfering with the interventions or possibly influencing outcomes.

          -  Participation in another clinical trial at the same time

          -  Unable to complete study questionnaires.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT04634682

Organization ID

RFT-MYO-2020-01


Responsible Party

Sponsor

Study Sponsor

Myogem Health Company, S.L.


Study Sponsor

, , 


Verification Date

April 2022