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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02399514
• Other study ID #: JF001 sleep
• Status: Completed
• Phase: N/A
• Start date: November 5, 2014
• Est. completion date: March 9, 2018

Study information

• Verified date: February 2019
• Source: Institut für Pneumologie Hagen Ambrock eV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 9, 2018
• Est. primary completion date: March 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COPD
• Emphysema
• Pulmonary Emphysema

Intervention

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

Locations

Country	Name	City	State
Germany	Helios Klinik Ambrock	Hagen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pneumologie Hagen Ambrock eV	PneumRx, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Quality of life Questionnaire	The St. George Respiratory Questionnaire (SGRQ) is designed to capture the health related quality of life.	3 times in one year