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

Institut für Pneumologie Hagen Ambrock eV

Status: Completed

Conditions: Emphysema; COPD

Treatments: Other: Polysomnographic diagnostic

Study type: Interventional

Funder types: Industry

Identifiers

NCT02399514

JF001 sleep

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

RePneum coils

Other group

Description:

Patients who needed lung volume reduction with RePneum coils

Treatment:

Other: Polysomnographic diagnostic