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Monitoring of Non-invasive Ventilation During Sleep in ALS

NCT ID: NCT01889043

Last Updated: 2015-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Brief Summary

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Non-invasive ventilation (NIV) has already shown to improve survival and quality of life in patients with amyotrophic lateral sclerosis (ALS). Quality of sleep seems already to be impaired in patients with preserved diaphragmatic dysfunction. Until now, only few research has been performed on the quality of sleep in patients with ALS when using NIV, and these data are mainly based on patient reported outcomes.Further on, only very little research has been done on patient-ventilator interaction.

Our study would like to perform research on quality of sleep before and after NIV use by using full polysomnography with incorporation of transcutaneous carbon dioxide measurement and built-in ventilator software.

Detailed Description

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Conditions

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Amyotrophic Lateral Sclerosis

Keywords

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Amyotrophic Lateral Sclerosis Noninvasive Ventilation Polysomnography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with ALS (according to El Escorial criteria) who are planned to start to use NIV, objectivated by a decreased inspiratory muscle force with a restrictive pulmonary function and

1. symptoms of nocturnal alveolar hypoventilation or
2. increased daytime arterial carbon dioxide partial pressure (PCO2)(\> 45 mmHg) or
3. a ≥ 10 mmHg increase in transcutaneous PCO2 during sleep in comparison to a normal awake supine value

Exclusion Criteria

* Patients \< 18 years
* Patients not willing to start NIV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Dr. Dries Testelmans

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dries Testelmans, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Bertien Buyse, MD, PhD

Role: STUDY_DIRECTOR

UZ Leuven

Locations

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UZ Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S53536

Identifier Type: -

Identifier Source: org_study_id