Improvement of Sleep Quality by RePneu® Coils in Advanced Pulmonary Emphysema
NCT ID: NCT02399514
Last Updated: 2019-02-11
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2014-11-05
2018-03-09
Brief Summary
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Patient's sleep will be studied in three Polysomnography measurement nights, one prior to Coil Treatment, one six months after, and one twelve month after.
Primary objective is to investigate differences in sleep quality 6 and 12 months after Coil Treatment.
Further endpoints are changes in daily activity and sleep (actigraphy), 6MWT, lung function parameters, and questionnaires (SGRQ, mMRC dyspnoe scale).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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RePneum coils
Patients who needed lung volume reduction with RePneum coils
Polysomnographic diagnostic
Polysomnographic diagnostic performed one prior to Coil Treatment, one six months after and one twelve month after Coil Treatment
Interventions
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Polysomnographic diagnostic
Polysomnographic diagnostic performed one prior to Coil Treatment, one six months after and one twelve month after Coil Treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* RePneu Coil treatment according to clinical criteria
Exclusion Criteria
* Participation in another clinical trial within the last 4 weeks
* Incapable of giving consent
* Known OSA (AHI\>10)
18 Years
ALL
No
Sponsors
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PneumRx, Inc.
INDUSTRY
Institut für Pneumologie Hagen Ambrock eV
INDUSTRY
Responsible Party
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Karl Josef Franke
Senior Physician
Principal Investigators
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Karl-Josef Franke, MD
Role: PRINCIPAL_INVESTIGATOR
Helios Klinik Ambrock
Locations
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Helios Klinik Ambrock
Hagen, North Rhine-Westphalia, Germany
Countries
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References
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Franke KJ, Domanski U, Schroder M, Nilius G. Effects of endobronchial coils for endoscopic lung volume reduction on sleep in COPD patients with advanced pulmonary emphysema. Sleep Breath. 2021 Jun;25(2):727-735. doi: 10.1007/s11325-020-02176-0. Epub 2020 Aug 26.
Other Identifiers
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JF001 sleep
Identifier Type: -
Identifier Source: org_study_id
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