search
Back to results

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

Primary Purpose

COPD, Emphysema

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Polysomnographic diagnostic
Sponsored by
Institut für Pneumologie Hagen Ambrock eV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for COPD focused on measuring Sleep, emphysema, coils, lung volume reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Helios Klinik Ambrock

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

RePneum coils

Arm Description

Patients who needed lung volume reduction with RePneum coils

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life Questionnaire
The St. George Respiratory Questionnaire (SGRQ) is designed to capture the health related quality of life.

Full Information

First Posted
March 23, 2015
Last Updated
February 8, 2019
Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
PneumRx, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02399514
Brief Title
Improvement of Sleep Quality by RePneu® Coils in Advanced Pulmonary Emphysema
Official Title
Verbesserung Der Schlafqualität Durch RePneu® Coils Zur Behandlung Des Fortgeschrittenen Lungenemphysems
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 5, 2014 (Actual)
Primary Completion Date
March 9, 2018 (Actual)
Study Completion Date
March 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
PneumRx, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Emphysema
Keywords
Sleep, emphysema, coils, lung volume reduction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RePneum coils
Arm Type
Other
Arm Description
Patients who needed lung volume reduction with RePneum coils
Intervention Type
Other
Intervention Name(s)
Polysomnographic diagnostic
Other Intervention Name(s)
PSG
Intervention Description
Polysomnographic diagnostic performed one prior to Coil Treatment, one six months after and one twelve month after Coil Treatment
Primary Outcome Measure Information:
Title
Sleep efficiency, measured in baseline and 6 and 12 month after coil treatment.
Description
Sleep Efficiency is evaluated by the ratio of WASO (Time "wake after sleep onset") to Sleep Period Time (SPT).
Time Frame
3 times in one year
Secondary Outcome Measure Information:
Title
Quality of life Questionnaire
Description
The St. George Respiratory Questionnaire (SGRQ) is designed to capture the health related quality of life.
Time Frame
3 times in one year
Other Pre-specified Outcome Measures:
Title
Activity: Physical activity measured by an actimeter over 7 days, before and 6 month after the coil treatment. The device is able to capture activity levels, sleep and wake times .
Time Frame
1 week in baseline and 6 month after coil treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl-Josef Franke, MD
Organizational Affiliation
Helios Klinik Ambrock
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Klinik Ambrock
City
Hagen
State/Province
NRW
ZIP/Postal Code
58091
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32845475
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs