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NCT02399514

Improvement of Sleep Quality by RePneu® Coils in Advanced Pulmonary Emphysema

Completed NA Last updated 11 February 2019
What this trial tests

NA trial testing Polysomnographic diagnostic in COPD in 20 participants. Completed in 9 March 2018.

Timeline
5 November 2014
Primary endpoint
9 March 2018
9 March 2018

Quick facts

Lead sponsorInstitut für Pneumologie Hagen Ambrock eV
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment20
Start date5 November 2014
Primary completion9 March 2018
Estimated completion9 March 2018
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Institut für Pneumologie Hagen Ambrock eV

Who can join

18 and older, any sex, with COPD or Emphysema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Improvement of sleep quality in emphysema patients is desirable. Yet, there are no data of patients treated with RePneu coils. This monocenter prospective study investigates the effect on sleep quality of RePneu coils for reduction of dynamic hyperinflation in advanced disease stages of pulmonary emphysema. 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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Lung volume reduction with endobronchial coils for patients with emphysema.
    Welling JBA, Slebos DJ. · · 2018 · cited 14× · PMID 30210833 · DOI 10.21037/jtd.2017.12.95
  2. Effects of endobronchial coils for endoscopic lung volume reduction on sleep in COPD patients with advanced pulmonary emphysema.
    Franke KJ, Domanski U, Schröder M, Nilius G. · · 2021 · cited 1× · PMID 32845475 · DOI 10.1007/s11325-020-02176-0

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Other recruiting trials for COPD

Currently open trials in the same condition.

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Data sources for this page

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