Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been withdrawn prior to enrollment.
(Was unable to recruit subjects)
Sponsor:
Information provided by (Responsible Party):
Dr. Hryar Attarian, Northwestern University
ClinicalTrials.gov Identifier:
NCT01563900
First received: March 23, 2012
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Fatigue
Multiple Sclerosis
Sleep Apnea
Device: Auto-titration CPAP
Device: Sham-CPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Continuous Positive Airway Pressure for Fatigue Treatment in Patients With Multiple Sclerosis and Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 10 point change in Modified Fatigue Impact Scale (MFIS) [ Time Frame: 78 ± 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in the Epworth sleeping scale (ESS). [ Time Frame: 78 ± 7 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2012
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: sham-CPAP group
The sham-CPAP device will be set at 4 centimeters of water pressure (cwp).
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
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563900

Locations
United States, Illinois
Northwestern UNiversity, Department of Neurology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Hrayr Attarian, MD Northwestern University
  More Information

Publications:

Responsible Party: Dr. Hryar Attarian, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01563900     History of Changes
Other Study ID Numbers: STU00052358
Study First Received: March 23, 2012
Last Updated: April 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
fatigue
multiple sclerosis
sleep apnea
CPAP

Additional relevant MeSH terms:
Apnea
Fatigue
Multiple Sclerosis
Sclerosis
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Dyssomnias
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 20, 2014