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

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ClinicalTrials.gov Identifier: NCT01363882
Recruitment Status : Terminated (Insufficient enrollment & high rate of failure to complete protocol)
First Posted : June 2, 2011
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
ALS Association
Information provided by (Responsible Party):
Columbia University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Other: Sleep study-guided adjustment of NIV Other: Standard initiation of NIV Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : February 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
  2. 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

  3. 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

  4. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363882


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
ALS Association
Investigators
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Principal Investigator: Robert C Basner, MD Columbia University
More Information
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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01363882    
Other Study ID Numbers: AAAC6753
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Keywords provided by Columbia University:
Amyotrophic Lateral Sclerosis
Noninvasive Ventilation
Respiratory Dysfunction
Positive Pressure Ventilation
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases