Noninvasive Ventilation in ALS Patients With Mild Respiratory Involvement

NCT00386464 | Completed Phase 2

• 1 other identifier: HL 67887-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Non-invasive ventilation or BiPAP®, which is a form of breathing support delivered through a facemask, is a successful treatment for the respiratory complications of amyotrophic lateral sclerosis (ALS). It has been shown to prolong survival, improve quality of life, and improve cognitive function. It is widely used among patients with ALS who have advanced breathing difficulties. It is not known whether there is benefit to using non-invasive ventilation earlier in the disease course. There is evidence that non-invasive ventilation may slow down the decline in breathing function. If this were true then it would make sense to start non-invasive ventilation use earlier than the current clinically accepted practices. The purpose of this study is to determine whether using non-invasive ventilation early in the course of disease can slow the decline in breathing function. Patients remain in the study for 6 months and are asked to make 7 clinic visits during which time they will undergo pulmonary function tests and complete questionnaires.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

bipap; lou gehrigs disease; motor neuron disease; respiratory muscles

Outcome Measures

Primary Outcomes (1)

• Decline in forced vital capacity

Secondary Outcomes (2)

• quality of life

• respiratory quality of life

Interventions

noninvasive positive pressure ventilation DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Probable or definite ALS by El Escorial criteria
• age \>17 years
• FVC \>60
• minimal respiratory symptoms (no orthopnea or dyspnea at rest)
• ability to provide informed consent

You may not qualify if:

• Presence of another neurodegenerative disease
• arterial CO2 above 45 mmHg
• O2 below 60 mmHg
• coexisting chronic lung disease unrelated to ALS
• presence of an unstable medical condition such as coronary artery disease, liver failure, renal failure or cancer in the 30 days preceding enrollment

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

Location

Related Links

• Johns Hopkins ALS Center

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

• Noah Lechtzin, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Charles M Wiener, MD

  Johns Hopkins University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 11, 2006
• Study Start: April 1, 2002
• Study Completion: September 1, 2007
• Last Updated: November 9, 2007

Record last verified: 2007-04

Locations

US (1)