Efficacy of Noninvasive Ventilation in Amyotrophic Lateral Sclerosis (ALS)

NCT00537641 | Completed

• 1 other identifier: AAAC2000
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the hypothesis that noninvasive ventilation (NIV) as prescribed in current medical practice for use in amyotrophic Lateral Sclerosis (ALS) patients fails to deliver adequate breathing support over a night of use in the patient's home. ALS patients who come to the ALS Center for their routine 3 month follow up exam and are currently using NIV will be asked to complete questionnaires regarding their quality of sleep, quality of life and general level of function, and to undergo a home sleep study, using a safe, comfortable and reliable breathing monitoring system during a night of sleep. If the questionnaires or the sleep study show failure of the breathing device, the investigators will work with the patient to fix the problem and then offer a second study to make sure that the changes were helpful. The results of this study may help to develop subsequent studies and to improve the guidelines used for care of ALS patients.

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Keywords

noninvasive ventilation

Outcome Measures

Primary Outcomes (2)

• Tolerance of bilevel PAP

  The ALS Functional Rating Scale - Revised (ALSFRS-R) will be administered to measure tolerance.

  Up to 3 months

• Score on Epworth Sleepiness Scale

  Objective evidence of nocturnal sleep-disordered breathing on the bilevel PAP will be measured.

  Up to 3 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ALS who are using nocturnal noninvasive ventilation to treat respiratory insufficiency will be screened for eligibility as below.

You may qualify if:

• clinical diagnosis of amyotrophic lateral sclerosis (El Escorial criteria)
• age 18 to 18 years old
• using nocturnal noninvasive ventilation to treat respiratory insufficiency at least 4 hours per night, for at least 4 nights per week

You may not qualify if:

• inability to safely use NIPPV because of bulbar dysfunction
• indications for tracheostomy assisted ventilation due to inability to clear secretions from the airway
• presence of comorbid conditions with a life expectancy \< 6 months
• presence of advanced dementia
• unwillingness to follow up at the Eleanor and Lou Gehrig ALS/MDA Center at Columbia University on a regular basis
• previously diagnosed obstructive sleep apnea
• residence outside the New York metropolitan area.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Eleanor and Lou Gehrig ALS/MDA Center at Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Robert Basner, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: October 1, 2007
• Study Start: May 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: June 1, 2011
• Last Updated: July 7, 2015

Record last verified: 2015-07

Locations

US (1)