NCT00958048

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2009

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

August 16, 2013

Status Verified

August 1, 2013

Enrollment Period

4.2 years

First QC Date

February 8, 2009

Last Update Submit

August 14, 2013

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosishypoventilation

Outcome Measures

Primary Outcomes (1)

  • Survival

    36 months

Secondary Outcomes (1)

  • Changes of PtcCO2 and PaCO2, admission or unexpected clinical visiting, and QoL

    36 months

Study Arms (2)

2

EXPERIMENTAL

ALS with non-invasive ventilation

Device: non-invasive ventilation

1

NO INTERVENTION

ALS without non-invasive ventilation

Interventions

non-invasive ventilationDEVICE

CPAP, BiPAP

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ALS patients who:
  • had FVC 40%-80% of predict
  • Pimax \< 60 mmHg
  • daytime PaCO2 \< 50 mmHg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peilin Lee

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Amyotrophic Lateral SclerosisHypoventilation

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesRespiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Peilin Lee, M.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

  • Whey Dong Wu, M.D.

    Naitonal Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2009

First Posted

August 13, 2009

Study Start

January 1, 2009

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

August 16, 2013

Record last verified: 2013-08

Locations

TW(1)