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| Name | Class |
|---|---|
| PneumRx, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RePneum coils | Other | Patients who needed lung volume reduction with RePneum coils |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polysomnographic diagnostic | Other | Polysomnographic diagnostic performed one prior to Coil Treatment, one six months after and one twelve month after Coil Treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | 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 . | 1 week in baseline and 6 month after coil treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl-Josef Franke, MD | Helios Klinik Ambrock | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helios Klinik Ambrock | Hagen | North Rhine-Westphalia | 58091 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32845475 | Derived | 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. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |