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OpenTrials
Completed

NCT Number: NCT02399514

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

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).

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Key information

Conditions

COPD Chronic Disease Disease Attributes Emphysema Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helios Klinik Ambrock

Hagen, North Rhine-Westphalia, 58091, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Polysomnographic diagnostic

Other

Polysomnographic diagnostic performed one prior to Coil Treatment, one six months after and one twelve month after Coil Treatment

Other names: PSG

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Institut für Pneumologie Hagen Ambrock eV

Industry

Collaborators

  • PneumRx, Inc.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 26, 2015
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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