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

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ClinicalTrials.gov Identifier: NCT01563900
Recruitment Status : Withdrawn (Was unable to recruit subjects)
First Posted : March 27, 2012
Last Update Posted : April 18, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Hryar Attarian, Northwestern University

Tracking Information
First Submitted Date  ICMJE March 23, 2012
First Posted Date  ICMJE March 27, 2012
Last Update Posted Date April 18, 2013
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2012)
10 point change in Modified Fatigue Impact Scale (MFIS) [ Time Frame: 78 ± 7 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2012)
Improvement in the Epworth sleeping scale (ESS). [ Time Frame: 78 ± 7 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Positive Airway Pressure (CPAP) for Fatigue in Patients With Multiple Sclerosis (MS) and Obstructive Sleep Apnea (OSA)
Official Title  ICMJE Continuous Positive Airway Pressure for Fatigue Treatment in Patients With Multiple Sclerosis and Obstructive Sleep Apnea
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.
Detailed Description

Multiple sclerosis (MS) is a demyelinating inflammatory disease that is one of the most common neurological causes of disability in young adults. Besides physical disability, fatigue is a very common symptom present in 76 to 92% of people with MS. The 1998 Multiple Sclerosis Council for clinical practice guidelines published a consensus definition: subjective lack of physical and/or mental energy that is perceived by the individual or caregiver to interfere with the usual and desired activity. Although fatigue may be difficult to differentiate from sleepiness, it is a clinically different symptom. Sleepiness is the tendency to fall asleep or doze off. Some reports that the prevalence of moderate to severe sleep problems in MS is significantly higher than in the general population 51.5% vs 33.1%. It has also been reported that poor sleep can correlate with depression in subject with MS. Few studies have examined the effect of stimulants, amantadine or modafinil for treatment of fatigue and have shown contradictory data as effective treatments in MS patients.

Obstructive sleep apnea (OSA) has also been seen described in MS. Few case reports studies have reported that MS patients with OSA treated with continuous positive airway pressure (CPAP) had improvement in fatigue but not quality of life. Although the prevalence of OSA in the MS population is unknown, it may as much as twice as common as in the general population, which is 3 to 7%. Aside from the increased risk of daytime sleepiness, mood disorders, cardiovascular risk factors and accidents, OSA has also been implicated in increasing inflammatory markers like tumor necrosis factor (TNF-α). Elevation in TNF-α has also been seen in MS patients complaining of fatigue, which is thought to play a role in pathophysiology of fatigue in MS. The rational of this study is to determine if treatment of OSA with CPAP in MS patients improves fatigue. If effective, CPAP may not only decrease the risk of long term complications but may also improve the quality of life and daily living of these patients.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Fatigue
  • Multiple Sclerosis
  • Sleep Apnea
Intervention  ICMJE
  • Device: Auto-titration CPAP
    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.
    Other Name: Respironics CPAP device will be used.
  • Device: Sham-CPAP
    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.
    Other Name: Respironics CPAP device
Study Arms  ICMJE
  • Sham Comparator: sham-CPAP group
    The sham-CPAP device will be set at 4 centimeters of water pressure (cwp).
    Intervention: Device: Sham-CPAP
  • Active Comparator: Auto-titration CPAP
    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.
    Intervention: Device: Auto-titration CPAP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 16, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 26, 2012)
32
Estimated Study Completion Date  ICMJE February 2016
Estimated Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01563900
Other Study ID Numbers  ICMJE STU00052358
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Hryar Attarian, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hrayr Attarian, MD Northwestern University
PRS Account Northwestern University
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP