NCT00879593

Brief Summary

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease affecting motoneurons, with a prevalence around 5/100.000. Respiratory muscle involvement is a major feature in ALS and remains the main prognostic factor. Timing and rate of progression of this respiratory muscle involvement is also highly variable among individuals. Respiratory manifestations justify a careful follow up including clinical evaluation, pulmonary function tests and blood gases. Prognostic value of respiratory muscle assessment has been clearly demonstrated in ALS, although several cut off values have been published. The clinical benefit of non invasive ventilation (NIV) is well established in ALS, but the optimal criteria for its initiation remain debated . The 1999 consensus for NIV selected classical criteria to consider NIV in patients with respiratory symptoms suggesting hypoventilation: daytime hypercapnia (PaCO2 \> 45 mmHg), nocturnal SaO2 \< 89 % more than 5 consecutive minutes and for progressive neuromuscular disorders (NMD) (mainly ALS), a vital capacity (VC) \< 50 % pred or a PImax \< 60 cmH2O. Besides daytime clinical and PFT assessment, nocturnal evaluation is essential in ALS. The prevalence of sleep apnea ranges from 16 % to 76 %. Transcutaneous PCO2 (tcPCO2) is an attractive technique to evaluate non invasively nocturnal hypoventilation. The technique is well validated in different settings. Its use in neuromuscular disorders (NMD) is recent. In particular one study has demonstrated a high predictive value of tcPCO2 for the development of daytime hypoventilation within 1 year. To our knowledge, this technique has not been specifically assessed in ALS. There is a potential role for nocturnal PtcCO2 monitoring in the close follow up of ALS patients. Indeed, a close respiratory follow up of ALS patients is essential to determine the optimal timing of NIV, avoiding the occurence of unexpected acute respiratory failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

April 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 10, 2009

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

5.2 years

First QC Date

April 9, 2009

Last Update Submit

January 25, 2017

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Nocturnal Transcutaneous PCO2

    6 months

Secondary Outcomes (1)

  • Pulmonary function

    6 months

Study Arms (1)

PtcCO2

EXPERIMENTAL
Device: PtcCO2

Interventions

PtcCO2DEVICE

Nocturnal assessment will be performed during the initial polysomnography (and at 6 months) with a combined PtcCO2/pulse oxymetry TOSCA500 Radiometer monitoring evaluating different physiological parameters.

PtcCO2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Amyotrophic lateral sclerosis :definite, probable or probable with EMG (Airlie House Criteria, 1998).
  • Forced vital capacity \>70% pred.
  • Daytime PaCO2 \<43 mmHg.
  • Venous HCO3- \<28 mmol/L

You may not qualify if:

  • Patients unable to perform pulmonary function tests or nocturnal recordings.
  • Coexisting significant lung disease: moderate to severe asthma or COPD
  • Current NIV, CPAP or oxygen therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

PEREZ

Lille, 59037, France

Location

Pôle des maladies respiratoires et service EFR- Centre hospitalier Regional Universitaire

Lille, France

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Thierry PEREZ, MD

    CHRU LILLE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 9, 2009

First Posted

April 10, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2014

Study Completion

January 1, 2017

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

FR(2)