Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 520 for:    ALS (Amyotrophic Lateral Sclerosis)

Polysomnography-directed Noninvasive Ventilation in Amyotrophic Lateral Sclerosis (ALS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01363882
Recruitment Status : Unknown
Verified May 2011 by Columbia University.
Recruitment status was:  Active, not recruiting
First Posted : June 2, 2011
Last Update Posted : June 2, 2011
Sponsor:
Collaborator:
ALS Association
Information provided by:
Columbia University

Tracking Information
First Submitted Date  ICMJE March 28, 2011
First Posted Date  ICMJE June 2, 2011
Last Update Posted Date June 2, 2011
Study Start Date  ICMJE February 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
Change from baseline in spirometric, respiratory muscle strength, and gas exchange measures [ Time Frame: Up to 6 months after starting NIV ]
FVC (forced vital capacity), FEV1 (forced expiratory volume in 1 second), MIP (maximum inspiratory pressure) and MEP (maximum expiratory pressure
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
  • Duration that the Mental Component Summary (MCS) is maintained above 75% of baseline score for the Medical Outcomes Study Health Survey (SF-12) [ Time Frame: Up to 6 months after starting NIV ]
  • Survival [ Time Frame: Up to 6 months after baseline ]
    Whether sleep study-titrated NIV is associated with trends to improved survival, compared with standardly prescribed (non-titrated) NIV
  • Nocturnal oxygenation and ventilation [ Time Frame: Up to 6 months after starting NIV ]
    Nadir oxygen saturation, number of oxygen desaturations of 3%/hr (ODI3), % time of sleep spent with oxygen saturation <90%, apnea-hypopnea index, asynchrony index
  • Modified Borg dyspnea score (see description) [ Time Frame: Up to 6 months after baseline ]
    The Modified Borg Dyspnea Scale is a 10-point Likert scale asking subjects to rate perceived shortness of breath, ranging from 0 (no breathlessness at all) to 10 (maximal breathlessness)
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 Polysomnography-directed Noninvasive Ventilation in Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE Progression of Respiratory Dysfunction in Amyotrophic Lateral Sclerosis (ALS) Patients: A Comparison of Standard of Practice vs Polysomnography-Directed Nocturnal Non-Invasive Positive Pressure Ventilation
Brief Summary Use of noninvasive ventilation (NIV, also known colloquially as "Bipap") has been associated in some studies with improvement in pulmonary function, quality of life and survival. NIV is typically applied during sleep, and without the benefit of sleep study to determine the optimal settings. The investigators have shown that when NIV is used in this fashion, failure of nocturnal oxygenation and ventilation is prominent. This study is randomizing patients to standard application of NIV vs application guided by use of sleep study data to determine the effect of titrated therapy on pulmonary function, quality of life and survival.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Amyotrophic Lateral Sclerosis (ALS)
Intervention  ICMJE
  • Other: Sleep study-guided adjustment of NIV
    Sleep studies will be performed at baseline, within 2 weeks to initially titrate NIV, and at 1, 3 and 6 months to assess NIV performance and adjust it as necessary based on oxygenation and ventilation parameters.
  • Other: Standard initiation of NIV
    NIV will be initiated and managed as per current standard of practice. Sleep studies will be performed at baseline, 2 weeks, 1, 3 and 6 months to gather data but will not influence NIV management. NIV will be adjusted by a respiratory therapist or the subject's primary physician per waking symptoms.
Study Arms  ICMJE
  • Active Comparator: Standard NIV
    Noninvasive ventilation (NIV) will be initiated and managed as per current standard of practice guided by the American Academy of Neurology (AAN) Practice Parameters (updated in 2009), in all subjects with amyotrophic lateral sclerosis (ALS) and a forced vital capacity of <50% predicted. Sleep studies will be performed at baseline, 2 weeks, 1, 3 and 6 months, but will not influence management of the NIV.
    Intervention: Other: Standard initiation of NIV
  • Experimental: Sleep study titrated NIV
    ALS subjects in this arm, who are offered NIV for Forced Vital Capacity (FVC) <50% as per AAN Practice Parameters, will have their initial level of NIV determined polysomnographically. They will be followed with sleep studies at 1 month, 3 months and 6 months to reassess NIV efficacy and NIV will be adjusted as necessary to optimize parameters of oxygenation and ventilation.
    Intervention: Other: Sleep study-guided adjustment of NIV
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 31, 2011)
40
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of probable or definite Amyotrophic Lateral Sclerosis (ALS) per El Escorial criteria
  • Between ages of 18 and 80 yrs old

Exclusion Criteria:

  • Inability to clear secretions from the airway
  • Life expectancy < 6 months from a comorbid condition
  • Dementia sufficient to impair ability to use NIV, perform respiratory muscle pressure testing (PFTs), or complete Health-related Quality of Life (HRQOL) instruments
  • Inability to follow up at the ALS Center on a regular basis
  • Previously diagnosed obstructive Sleep Apnea
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 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 NCT01363882
Other Study ID Numbers  ICMJE AAAC6753
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert Basner, MD; Professor of Clinical Medicine, Columbia University College of Physicians and Surgeons
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE ALS Association
Investigators  ICMJE
Principal Investigator: Robert C Basner, MD Columbia University
PRS Account Columbia University
Verification Date May 2011

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