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

Columbia University

Status: Terminated

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Treatments: Other: Sleep study-guided adjustment of NIV; Other: Standard initiation of NIV

Study type: Interventional

Funder types: Other

Identifiers

NCT01363882

AAAC6753

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Standard NIV

Active Comparator group

Description:

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.

Treatment:

Other: Standard initiation of NIV

Sleep study titrated NIV

Experimental group

Description:

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.

Treatment:

Other: Sleep study-guided adjustment of NIV