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

Not Applicable

Completed

• Conditions: COPD; Emphysema
• Interventions: Other: Polysomnographic diagnostic

• Registration Number: NCT02399514
• Lead Sponsor: Institut für Pneumologie Hagen Ambrock eV

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-05
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-26
• Primary Completion: 2018-03-09
• Study Completion: 2018-03-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Written consent
• RePneu Coil treatment according to clinical criteria

Exclusion Criteria

• Pregnancy or nursing period
• Participation in another clinical trial within the last 4 weeks
• Incapable of giving consent
• Known OSA (AHI>10)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RePneum coils	Polysomnographic diagnostic	Patients who needed lung volume reduction with RePneum coils

Primary Outcome Measures

Name	Time	Method
Sleep efficiency, measured in baseline and 6 and 12 month after coil treatment.	3 times in one year	Sleep Efficiency is evaluated by the ratio of WASO (Time "wake after sleep onset") to Sleep Period Time (SPT).

Secondary Outcome Measures

Name	Time	Method
Quality of life Questionnaire	3 times in one year	The St. George Respiratory Questionnaire (SGRQ) is designed to capture the health related quality of life.

Trial Locations

Locations (1)

Helios Klinik Ambrock; 🇩🇪 Hagen, NRW, Germany