NCT02399514

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

Verbesserung Der Schlafqualität Durch RePneu® Coils Zur Behandlung Des Fortgeschrittenen Lungenemphysems

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Institut für Pneumologie Hagen Ambrock eV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• COPD
• Emphysema

Interventions

Type	Name	Description
OTHER	Polysomnographic diagnostic	Polysomnographic diagnostic performed one prior to Coil Treatment, one six months after and one twelve month after Coil Treatment

Timeline

• Start date: 2014-11-05
• Primary completion: 2018-03-09
• Completion: 2018-03-09
• First posted: 2015-03-26
• Last updated: 2019-02-11

Locations

1 site across 1 country: Germany