---
title: Effect of MYODM on Quality of Life, Fatigue and Hypersomnia in Patients With Myotonic Dystrophy Type 1
nct_id: NCT04634682
overall_status: COMPLETED
phase: NA
sponsor: Myogem Health Company, S.L.
study_type: INTERVENTIONAL
primary_condition: Myotonic Dystrophy 1
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04634682.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04634682"
ct_last_update_post_date: 2022-04-06
last_seen_at: "2026-05-12T06:56:49.113Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT04634682](https://clinicaltrials.gov/study/NCT04634682)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Myogem Health Company, S.L.
- **Conditions:** Myotonic Dystrophy 1
- **Start Date:** 2020-11-09
- **Completion Date:** 2021-12-03
- **CT.gov Last Update:** 2022-04-06

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **MYODM** (EXPERIMENTAL) — MYODM, three times a day, orally
- **No intervention** (NO_INTERVENTION) — Patients will follow the same evaluation schedule but will not receive MYODM

## Interventions

- **MYODM** (DIETARY_SUPPLEMENT) — Formulated composition containing Theobroma cacao supplemented with caffeine

## Primary Outcomes

- **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

## Secondary Outcomes

- **Change in Physical activity and daytime sleepiness measured with GeneActiv actometer** _(time frame: Screening, Baseline, Month 6)_

## Locations (1)

- Hospital Universitario Donostia, San Sebastián, Guipuzkoa, Spain

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital universitario donostia|san sebastián|guipuzkoa|spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04634682.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04634682*  
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