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

Not Applicable

Terminated

• Conditions: Amyotrophic Lateral Sclerosis (ALS)

• Registration Number: NCT01363882
• Lead Sponsor: Columbia University

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 available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-05-31
• Study First Posted: 2011-06-02
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in spirometric, respiratory muscle strength, and gas exchange measures	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

Name	Time	Method
Duration that the Mental Component Summary (MCS) is maintained above 75% of baseline score for the Medical Outcomes Study Health Survey (SF-12)	Up to 6 months after starting NIV
Survival	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	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)	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)

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States