NCT01563900|Withdrawn
Study Stopped
Was unable to recruit subjects
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Sponsor study identifier
interventional
0
1 country
1
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 23, 2012
Actual (reported)March 27, 2012
Actual (reported)February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
10 point change in Modified Fatigue Impact Scale (MFIS)
78 ± 7 days
Improvement in the Epworth sleeping scale (ESS).
78 ± 7 days
The sham-CPAP device will be set at 4 centimeters of water pressure (cwp).
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.
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.
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.
Northwestern UNiversity, Department of Neurology
Chicago, Illinois, 60611, United States
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.
Reder AT, Antel JP. Clinical spectrum of multiple sclerosis. Neurol Clin. 1983 Aug;1(3):573-99.
Hrayr Attarian, MD
Northwestern University
0 participants (actual enrollment reported by the registry).
First Submitted
March 23, 2012
First Posted
March 27, 2012
Study Start
February 2012
Date type not reportedThis date has not been verified as actual or estimated.
Use of Audio Recordings of Self-Hypnosis and Meditation for Fatigue Management in Multiple Sclerosis
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Primary Completion
February 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 18, 2013
Record last verified: 2013-04
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