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

NCT01563900 | Withdrawn

• 1 other identifier: STU00052358
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fatigue; Multiple Sclerosis; Sleep Apnea

Keywords

fatigue; multiple sclerosis; sleep apnea; CPAP

Outcome Measures

Primary Outcomes (1)

• 10 point change in Modified Fatigue Impact Scale (MFIS)

  78 ± 7 days

Secondary Outcomes (1)

• Improvement in the Epworth sleeping scale (ESS).

  78 ± 7 days

Study Arms (2)

sham-CPAP group

SHAM COMPARATOR

The sham-CPAP device will be set at 4 centimeters of water pressure (cwp).

Device: Sham-CPAP

Auto-titration CPAP

ACTIVE COMPARATOR

This group will received an auto-titration CPAP, which will have a pressure range of 5 to 15 cwp. This device delivers pressure as needed by the patient at any given time while using the device.

Device: Auto-titration CPAP

Interventions

Auto-titration CPAP DEVICE

An auto-titration CPAP will be set at a pressure between 5 to 15 cwp. This device delivers pressure as needed by the patient at any given time while using the device.

Also known as: Respironics CPAP device will be used.

Auto-titration CPAP

Sham-CPAP DEVICE

The sham-CPAP device will be set at 4 centimeters of water pressure (cwp). An exhalation connector will be place between the mask interface and the tubing without the enlarged port to maintain blinding; the final pressure delivered to the participant will be 2 cwp.

Also known as: Respironics CPAP device

sham-CPAP group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern UNiversity, Department of Neurology

Chicago, Illinois, 60611, United States

Location

Related Publications (13)

• Krupp LB, Coyle PK, Doscher C, Miller A, Cross AH, Jandorf L, Halper J, Johnson B, Morgante L, Grimson R. Fatigue therapy in multiple sclerosis: results of a double-blind, randomized, parallel trial of amantadine, pemoline, and placebo. Neurology. 1995 Nov;45(11):1956-61. doi: 10.1212/wnl.45.11.1956.

  PMID: 7501140 BACKGROUND

• Reder AT, Antel JP. Clinical spectrum of multiple sclerosis. Neurol Clin. 1983 Aug;1(3):573-99.

  PMID: 6095009 BACKGROUND

• Krupp LB, Serafin DJ, Christodoulou C. Multiple sclerosis-associated fatigue. Expert Rev Neurother. 2010 Sep;10(9):1437-47. doi: 10.1586/ern.10.99.

  PMID: 20819014 BACKGROUND

• Shahid A, Shen J, Shapiro CM. Measurements of sleepiness and fatigue. J Psychosom Res. 2010 Jul;69(1):81-9. doi: 10.1016/j.jpsychores.2010.04.001.

  PMID: 20630266 BACKGROUND

• Attarian HP, Brown KM, Duntley SP, Carter JD, Cross AH. The relationship of sleep disturbances and fatigue in multiple sclerosis. Arch Neurol. 2004 Apr;61(4):525-8. doi: 10.1001/archneur.61.4.525.

  PMID: 15096400 BACKGROUND

• Bamer AM, Johnson KL, Amtmann DA, Kraft GH. Beyond fatigue: Assessing variables associated with sleep problems and use of sleep medications in multiple sclerosis. Clin Epidemiol. 2010 May 1;2010(2):99-106. doi: 10.2147/CLEP.S10425.

  PMID: 20838467 BACKGROUND

• Merlino G, Fratticci L, Lenchig C, Valente M, Cargnelutti D, Picello M, Serafini A, Dolso P, Gigli GL. Prevalence of 'poor sleep' among patients with multiple sclerosis: an independent predictor of mental and physical status. Sleep Med. 2009 Jan;10(1):26-34. doi: 10.1016/j.sleep.2007.11.004. Epub 2008 Jan 22.

  PMID: 18207453 BACKGROUND

• Rammohan KW, Rosenberg JH, Lynn DJ, Blumenfeld AM, Pollak CP, Nagaraja HN. Efficacy and safety of modafinil (Provigil) for the treatment of fatigue in multiple sclerosis: a two centre phase 2 study. J Neurol Neurosurg Psychiatry. 2002 Feb;72(2):179-83. doi: 10.1136/jnnp.72.2.179.

  PMID: 11796766 BACKGROUND

• Jackson ML, Stough C, Howard ME, Spong J, Downey LA, Thompson B. The contribution of fatigue and sleepiness to depression in patients attending the sleep laboratory for evaluation of obstructive sleep apnea. Sleep Breath. 2011 Sep;15(3):439-45. doi: 10.1007/s11325-010-0355-2. Epub 2010 May 6.

  PMID: 20446116 BACKGROUND

• Kohli P, Balachandran JS, Malhotra A. Obstructive sleep apnea and the risk for cardiovascular disease. Curr Atheroscler Rep. 2011 Apr;13(2):138-46. doi: 10.1007/s11883-011-0161-8.

  PMID: 21253882 BACKGROUND

• Tamaki S, Yamauchi M, Fukuoka A, Makinodan K, Koyama N, Tomoda K, Yoshikawa M, Kimura H. Production of inflammatory mediators by monocytes in patients with obstructive sleep apnea syndrome. Intern Med. 2009;48(15):1255-62. doi: 10.2169/internalmedicine.48.2366. Epub 2009 Aug 3.

  PMID: 19652426 BACKGROUND

• Heesen C, Nawrath L, Reich C, Bauer N, Schulz KH, Gold SM. Fatigue in multiple sclerosis: an example of cytokine mediated sickness behaviour? J Neurol Neurosurg Psychiatry. 2006 Jan;77(1):34-9. doi: 10.1136/jnnp.2005.065805.

  PMID: 16361589 BACKGROUND

• Kaminska M, Kimoff RJ, Benedetti A, Robinson A, Bar-Or A, Lapierre Y, Schwartzman K, Trojan DA. Obstructive sleep apnea is associated with fatigue in multiple sclerosis. Mult Scler. 2012 Aug;18(8):1159-69. doi: 10.1177/1352458511432328. Epub 2011 Dec 19.

  PMID: 22183937 BACKGROUND

MeSH Terms

Conditions

Fatigue; Multiple Sclerosis; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Hrayr Attarian, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: March 27, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2016
• Last Updated: April 18, 2013

Record last verified: 2013-04

Locations

US (1)