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

NCT02399514 | Completed

• 1 other identifier: JF001 sleep
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

COPD; Emphysema

Keywords

Sleep; emphysema; coils; lung volume reduction

Outcome Measures

Primary Outcomes (1)

• 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).

  3 times in one year

Secondary Outcomes (1)

• Quality of life Questionnaire

  3 times in one year

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 .

  1 week in baseline and 6 month after coil treatment

Study Arms (1)

RePneum coils

OTHER

Patients who needed lung volume reduction with RePneum coils

Other: Polysomnographic diagnostic

Interventions

Polysomnographic diagnostic OTHER

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

Also known as: PSG

RePneum coils

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written consent
• RePneu Coil treatment according to clinical criteria

You may not qualify if:

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

Sponsors & Collaborators

• Institut für Pneumologie Hagen Ambrock eV: lead
• PneumRx, Inc.: collaborator

Study Sites (1)

Helios Klinik Ambrock

Hagen, North Rhine-Westphalia, 58091, Germany

Location

Related Publications (1)

• 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.

  PMID: 32845475 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

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

Study Officials

• Karl-Josef Franke, MD

  Helios Klinik Ambrock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: March 26, 2015
• Study Start: November 5, 2014
• Primary Completion: March 9, 2018
• Study Completion: March 9, 2018
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

DE (1)