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Effects of Nocturnal Non-invasive Ventilation in Patients With Amyotrophic Lateral Sclerosis

This study has been completed.
Sponsor:
Collaborator:
Taipei Veterans General Hospital, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00958048
First received: February 8, 2009
Last updated: August 14, 2013
Last verified: August 2013

February 8, 2009
August 14, 2013
January 2009
April 2013   (final data collection date for primary outcome measure)
Survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00958048 on ClinicalTrials.gov Archive Site
Changes of PtcCO2 and PaCO2, admission or unexpected clinical visiting, and QoL [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Nocturnal Non-invasive Ventilation in Patients With Amyotrophic Lateral Sclerosis
Effects of Early Intervention With Nocturnal Non-invasive Ventilation in Patients With Amyotrophic Lateral Sclerosis: A Randomized, Controlled Trial

Specific aims:

Aim 1. To determine the incidence of hypoventilation in Amyotrophic Lateral Sclerosis (ALS) patients.

Aim 2. To identify the clinical characteristics and risk factors associated .

Aim 3. To determine the effect of early intervention with nocturnal NIV on the prognosis of ALS patients.

Objectives: Amyotrophic lateral sclerosis is the commonest motor neuron disease with incidence of 0.8 person-years in Chinese. Respiratory muscle function has been proposed to be a strong predictor of quality of life (QoL) and survival in ALS. Some studies suggest that most patients with ALS developed hypoventilation when their vital capacity (FVC) is less than 50% of predicted value. However, the incidence of hypoventilation and factors associated with hypoventilation in ALS patients is not clear. Also, there is still no consensus as to which physiologic marker should be used as a trigger for the initiation of non-invasive ventilation (NIV) in ALS patients. The conflicts of studies come from variable subgroup of ALS, pulmonary function at enrollment, techniques used to diagnose ALS, time to apply NIV, and target endpoint. Therefore, this project aimed to study ALS patients who had relatively preserved respiratory muscle function and no respiratory failure at clinical to achieve three goals: (1) To determine the incidence of hypoventilation in ALS patients (2) To identify the clinical characteristics and risk factors associated with hypoventilation in ALS patients (3) To determine the effect of early intervention with NIV on the prognosis of ALS patients Study design: Randomized, controlled trial Participants: ALS patients whose FVC 40%-80% of predict, Pimax <60mmHg, and daytime PaCO2<50mmHg Protocol: Eligible patients with whole-night polysomnography (PSG) and transcutaneous CO2 (PtcCO2). Enrolled patients were randomized to standard treatment or NIV. The primary endpoint of prognosis was survival. The secondary endpoint was changes of PtcCO2 and PaCO2, unexpected admission or clinic visiting, daytime function and QoL.

Statistic: The baseline demographics of patients with or without hypoventilation were compared to determine the factors associated with hypoventilation in ALS patients. The impact of NIV in ALS patients was determined by comparing the primary and secondary goals between standard treatment and NIV group. A two-sided p value of < 0.05 was considered statistically significant.

Clinical implication: Hypoventilation at ALS patients who had relatively preserved respiratory muscle function and no respiratory failure at clinical sleep was common, early identification through PSG screening and PtcCO2 will allow for the early diagnosis and intervention. Understanding the time of applying NIV and the effect on prognosis in ALS will allow for the early intervention and prediction of outcomes.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Amyotrophic Lateral Sclerosis
Device: non-invasive ventilation
CPAP, BiPAP
  • Experimental: 2
    ALS with non-invasive ventilation
    Intervention: Device: non-invasive ventilation
  • No Intervention: 1
    ALS without non-invasive ventilation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ALS patients who:

    • had FVC 40%-80% of predict
    • Pimax < 60 mmHg
    • daytime PaCO2 < 50 mmHg

Exclusion Criteria:

  • Refuse to participate
  • Require mechanical ventilation
  • Active neurologic event other than ALS
  • Obstructive pulmonary disease
  • Active infection
  • Need sedatives or narcotics within 3 days of sleep study
  • Participating in other study at the same time
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00958048
200812112R, 2011-04-011LA
Yes
National Taiwan University Hospital
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Principal Investigator: Peilin Lee, M.D. National Taiwan University Hospital
Principal Investigator: Whey Dong Wu, M.D. Naitonal Taiwan University Hospital
National Taiwan University Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP