Continuous Positive Airway Pressure (CPAP) for Fatigue in Patients With Multiple Sclerosis (MS) and Obstructive Sleep Apnea (OSA)

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Fatigue, Multiple Sclerosis, Sleep Apnea

In brief

Fatigue is a symptom present in 76 to 92% of people with multiple sclerosis (MS). Fatigue is usually described as an overwhelming sense of tiredness, lack of energy, and feeling of exhaustion which is different from sleepiness. Fatigue is also a symptom commonly seen in people with obstructive sleep apnea (OSA). The overall objective is to develop a non-pharmacological treatment for fatigue in MS. The objective of this study is to evaluate if treatment of OSA with continuous positive airway pressure (CPAP) improves fatigue in MS subjects with OSA and fatigue. This will be a small pilot randomized, double-blind, sham-controlled clinical trial; the control group will be treated with a sham-CPAP machine and intervention group will be treated with an auto-titration CPAP machine. The primary outcome measure will be improvement (decrease) in the Modified Fatigue Impact Scale from baseline. The duration of intervention will be 12 weeks to achieve a clinical response in the treatment group. After this intervention participants in both groups will be offered a referral to the sleep clinic of their preference for formal treatment as per standard of care.

Key facts

Study ID

NCT01563900

Run by

Northwestern University

People needed

0

Starts

2012-02-01

Expected to finish

2016-02-01

Last updated by the study team

2013-04-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-65 years old
• Diagnosis of clinical MS as defined by the 2010 McDonald criteria
• Have either relapsing remitting, primary progressive or secondary progressive forms of MS
• expanded disability status scale ≤5
• Complaint of fatigue defined subjective lack of physical and/or mental energy that is perceived by the individual or caregiver to interfere with the usual and desired activity.
• Berlin questionnaire score of ≥2 35
• Mild to moderate OSA defined as Apnea hypopnea index (AHI) of ≥ 5 and < 30 events/hour on baseline ambulatory PSG

You may not qualify if…

• Prior diagnosis, past or current treatment for sleep related breathing disorder
• Severe sleep apnea defined as AHI ≥ 30 events/hour on baseline ambulatory PSG,
• Prior diagnosis of restless leg syndrome, parasomnias, insomnia, and narcolepsy
• Prior diagnosis of pulmonary disease: asthma, chronic obstructive pulmonary disease and bronchiectasis
• Diagnosis of clinical depression or Center for epidemiologic studies-depression scale(CES-D)score of ≥ 16 36,37
• An acute MS exacerbation in the last 3 months. If patient has an acute exacerbation during the study, the patient will be excluded from the study as this can be a cause fatigue
• Started on any disease modifying treatment (either primary or second line agents) or have switched to a second therapy in the last 6 month poor sleep and fatigue can be side effects.
• Current use of sedative-hypnotics medications, tricyclic, antidepressants, or trazodone.
• Started or change in dose within the last 3 months of amantadine, modafinil, armodafinil, or other stimulating agent for MS related fatigue
• Pregnancy
• Unstable medical or psychiatric condition

Where it is running

• Northwestern UNiversity, Department of Neurology — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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