Sleep Medical Treatment in MS Patients Suffering From Fatigue

Not Applicable

Terminated

• Conditions: Fatigue; Multiple Sclerosis
• Interventions: Other: Sleep medical treatment

• Registration Number: NCT03759249
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

This study evaluates the effect of an extensive sleep medical investigation and of the subsequent treatment on multiple sclerosis (MS) related fatigue (provided a previously unknown sleep disorder was found).

Detailed Description

Fatigue is among the most frequent symptoms in multiple sclerosis (MS) patients with substantial negative impact on quality of life and employment status; one third of patients describe fatigue as their most burdensome symptom. The enormous personal and socioeconomic burden of this symptom is in striking contrast to the limited therapeutic options.

In a previous polysomnographic study, we found a strong association between sleep disorders and fatigue in MS, measured with the Modified Fatigue Impact Scale (MFIS) and the Fatigue-Severity-Scale (FSS). Thus, it is conceivable that a consequent treatment of sleep disorders may improve fatigue, at least in a subset of patients which would yield a great benefit as pharmacological treatment options for fatigue are insufficient.

All consecutive MS patients of our outpatient clinic will be screened for fatigue. In case of fatigue (MFIS values \> 34) or signs of sleep disorders (Pittsburgh sleep quality index \> 5) the MS patients were invited to participate in the study. All MS patients will be interviewed by a sleep specialist, and will fill out questionnaires. Afterwards, they will be investigated by two consecutive polysomnographies in the sleep laboratory, followed (if necessary) by multiple sleep latencies tests. Subsequently, a sleep medical diagnosis will be established (no sleep disorder or sleep apnea or insomnia or restless legs syndrome or any other sleep disorders according to the International Classification of Sleep disorders 3th ed.). The primary endpoint will be the Modified Fatigue Impact Scale (MFIS) value six months after sleep medical treatment.

Study Timeline

• Study Start: 2015-12-08
• Study First Submitted: 2018-11-28
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• multiple sclerosis
• fatigue
• MFIS values greater than 34 or Pittsburgh Sleep Quality Index greater than 5

Exclusion Criteria

• Expanded disability status scale greater than 5
• relapse in the last four weeks
• immunosuppressants in the last two years
• therapy with positive airway pressure (CPAP or BIPAP/ASV)
• treatment with opioids
• treatment with oestrogen
• body mass index greater than 40
• depression (beck depression inventory (BDI) values greater 20; in case of treatment with antidepressants BDI values greater than 12 or suicidal ideas)
• pregnancy
• anaemia (hemoglobine < 11,5 g/dl in women and < 12,5 g/dl in men)
• thyroid-stimulating hormone outside the normal range
• renal insufficiency (creatinine clearance < 75ml/min)
• elevated transaminases (tripled)
• chronic heart failure (NYHA II, III or IV)
• respiratory insufficiency (CO2 > 45 mmHg or pO2 < 60 mmHg (capillary or arterial) or long-term oxygen therapy)
• carcinoma in the medical history (except for curative approach without relapse in the last 10 years)
• chemotherapy
• poorly controlled diabetes (Glycated hemoglobin greater than 8 per cent)
• pituitary adenomas
• diabetes insipidus
• fibromyalgia
• unclear weight loss greater than 12 kg in one year
• myasthenia gravis or any neuromuscular disorder
• ulcerating colitis or Crohn's disease
• AIDS or infection with HIV
• acute infection in the last two months
• stroke or apoplexy in the history
• Parkinson's Disease
• substance or drug abuse
• participation in other interventional trials
• capacity for consent is lacking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Sleep medical treatment	Standard Treatment of Sleep disorder according to applicable guideline

Primary Outcome Measures

Name	Time	Method
Modified Fatigue Impact Scale value	six months after treatment	Measuring fatigue; Total value of the Modified Fatigue Impact Scale: 0-84 (min-max), higher values represent increased fatigue, and lower values are considered to be a better outcome

Trial Locations

Locations (1)

Charité University Medicine Berlin; 🇩🇪 Berlin, Germany