RESEARCH: Clinical Trials

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NON-INVASIVE VENTILATION IN ALS

Prevalence and Severity of Nocturnal Oxygenation and Ventilation Failure in Patients With ALS Using Bilevel Non Invasive Ventilation (NIV, aka "BiPAP")

Design:

• Prospective, cross sectional observational study to be completed in one year.
  
  
• Enrollment from follow-up patients in ALS multidisciplinary clinic
  
  
• Consenting patients undergo one night of polysomnography with a Level III system of unattended home monitoring
  
  
• Primary end point: prevalence, severity of nocturnal oxygenation
  
  
• Secondary end point: ALSFRS-R

Eligibility:

• A clinical diagnosis of possible, laboratory-supported probable, probable or definite ALS, according to modified EL Escorial criteria
  
  
• Age > 18 years
  
  
• Compliance with BiPAP for at least 4 hrs per night for at least 4 nights a week for one month
  
  
• Exclusion Criteria:
  
  
  • Known obstructive sleep apnea of advanced dementia by previous diagnosis
    
    
  • Inability to safely use BiPAP because of bulbar dysfunction
    
    
  • Comorbid conditions with a life expectancy < 6 months

The Effect of Non Invasive Ventilation (NIV, aka "BiPAP") on Respiratory Muscle and Autonomic Function in ALS

Design:

• Short-term (1 hour) use of NIV causes measurable change in PFT's (pulmonary functioning tests) and autonomic function.

Eligibility:

• Age > 18 years, and less than 80 years.
  
  
• Advised to begin NIV for respiratory insufficiency as per current practice parameters (FVC is less than 50% or respiratory symptoms).
  
  
• Able to perform pulmonary functioning tests, either with or without the use of an assistive facemask.
  
  
• Exclusion Criteria:
  
  
  • Prior use of NIV (BiPap)
    
    
  • Inability to safely use BiPAP
    
    
  • Indications for tracheostomy assisted ventilation because of inability to clear secretions from the airway.
    
    
  • Presence of advanced dementia

Progression of Respiratory Dysfunction in ALS Patients: A Comparison of Standard of Practice vs Polysomnography-Directed Nocturnal Non Invasive Ventilation (NIV, aka "BiPAP")

Design:

• NIV directed by sleep studies is superior to NIV prescribed per standard-of-care in maintaining lung function and quality of life.

Eligibility:

• Age > 18 years, and less than 80 years.
  
  
• Advised to begin NIV for respiratory insufficiency as per current practice parameters (FVC is less than 50% or respiratory symptoms).
  
  
• Able to perform pulmonary functioning tests, either with or without the use of an assistive facemask.
  
  
• Exclusion Criteria:
  
  
  • Prior use of NIV (BiPap)
    
    
  • Inability to safely use BiPAP
    
    
  • Indications for tracheostomy assisted ventilation because of inability to clear secretions from the airway.
    
    
  • Presence of advanced dementia

For further information, please contact Amy Atkeson: ad720@columbia.edu and phone number (212) 305-2027.