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

February 8, 2019 updated by: Karl Josef Franke, Institut für Pneumologie Hagen Ambrock eV

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Hagen, NRW, Germany, 58091
        • Helios Klinik Ambrock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: RePneum coils
Patients who needed lung volume reduction with RePneum coils
Other: Polysomnographic diagnostic
Polysomnographic diagnostic performed one prior to Coil Treatment, one six months after and one twelve month after Coil Treatment
Other Names:
  • PSG

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life Questionnaire
Time Frame: 3 times in one year
The St. George Respiratory Questionnaire (SGRQ) is designed to capture the health related quality of life.
3 times in one year

Other Outcome Measures

Outcome Measure
Time Frame
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
1 week in baseline and 6 month after coil treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut für Pneumologie Hagen Ambrock eV

Collaborators

PneumRx, Inc.

Investigators

  • Principal Investigator: Karl-Josef Franke, MD, Helios Klinik Ambrock

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2014

Primary Completion (Actual)

March 9, 2018

Study Completion (Actual)

March 9, 2018

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 8, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JF001 sleep

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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