Study Results
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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TERMINATED
NA
8 participants
INTERVENTIONAL
2013-02-28
2017-06-30
Brief Summary
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Detailed Description
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Fatigue and daytime sleepiness are typical symptoms of alveolar hypoventilation. NIV has the intention to improve these symptoms but no research has been performed whether these improvements also objectively improve physical activity. Further on, no research has been performed on muscle strength and muscle fatigue.
Patients' physical activity, physical capacity and sleep quality will be measured before NIV initiation, after 3 months and 1 year of NIV use.
To start NIV, patients will be admitted to our sleep laboratory for 5 days/4 nights. Polysomnography will be used during NIV titration.
Physical activity will each time be measured by 2 activity monitors during 5 days.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients with RLD initiating NIV
Patients with RLD initiating NIV according to Belgian Health guidelines are followed-up before and after NIV initiation
NIV
Interventions
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NIV
Eligibility Criteria
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Inclusion Criteria
* symptoms of nocturnal alveolar hypoventilation or
* increased daytime pressure of arterial CO2 (PaCO2) (\>45 mmHg) or
* \>= 10 mmHg increase in PaCO2 during sleep in comparison to a normal awake supine value
Exclusion Criteria
* severe cardiac arrythmias or conduction disturbances
* severe mental disturbances
* amyotrophic lateral sclerosis
* total wheelchair-dependent patients
16 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Dr. Dries Testelmans
MD, PhD
Principal Investigators
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Dries Testelmans, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Bertien Buyse, MD,PhD
Role: STUDY_DIRECTOR
Universitaire Ziekenhuizen KU Leuven
Locations
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UZ Leuven
Leuven, , Belgium
Countries
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Other Identifiers
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S54220
Identifier Type: -
Identifier Source: org_study_id