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Influence of an Inverse Pressure Ramp in Long-term Non-invasive Ventilation on Dyspnea in the Morning After Therapy

Primary Purpose

Noninvasive Ventilation, Dyspnea

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

softSTOPP

About this trial

This is an interventional treatment trial for Noninvasive Ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years
Diagnosis of a chronic obstructive pulmonary disease (COPD) with chronic hypercapnic insufficiency
Therapy with prismaVENT 30, firmware V 3.3 or higher, mode S/T, stable device settings at the time of inclusion without need to adapt ventilation parameters
May have co-existing obstructive sleep apnea syndrome
Subjective dyspnea ≥3 (Borg scale) after end of ventilation therapy in the morning
Written informed consent for study participation including data protection

Exclusion Criteria:

Missing written informed consent for study participation including data protection
Contraindication for positive airway pressure therapy
Use of the softSTOPP feature before study inclusion
Participation in another study, which influences NIV therapy by defining device settings or titration
Concomitant oxygen therapy

Sites / Locations

Krankenhaus BethanienRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

softSTOPP active

softSTOPP inactive

Arm Description

Outcomes

Primary Outcome Measures

Change of dyspnea level from baseline to 12 weeks

Delta value of morning dyspnea from baseline to 12 weeks as measured by the Borg Scale. The Borg Scale ranges from 0 (no perceived dyspnea at all) to 10 (maximum perceived dyspnea).

Secondary Outcome Measures

Full Information

NCT ID

NCT04093427

First Posted

September 16, 2019

Last Updated

October 6, 2021

Sponsor

Wissenschaftliches Institut Bethanien e.V

Collaborators

Löwenstein Medical Technology GmbH & Co. KG

1. Study Identification

Unique Protocol Identification Number

NCT04093427

Brief Title

Influence of an Inverse Pressure Ramp in Long-term Non-invasive Ventilation on Dyspnea in the Morning After Therapy

Official Title

Einfluss Einer Inversen Druckrampe Bei Der Langzeit-Therapie Mit Nicht-invasiver Ventilation Auf Dyspnoe am Morgen Nach Therapie-Ende. Influence of an Inverse Pressure Ramp in the Long-term Therapy Mit Non-invasive Ventilation on Dyspnea in the Morning After Therapy.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

October 1, 2022 (Anticipated)

Study Completion Date

October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wissenschaftliches Institut Bethanien e.V

Collaborators

Löwenstein Medical Technology GmbH & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Patients being treated with non-invasive home mechanical ventilation (NIV) may experience morning dyspnea after each night of NIV use, when the therapy is abruptly ended. This study aims to show that dyspnea intensity can be significantly reduced by a gentle NIV therapy end, delivered by a continuously decreasing pressure level (inverse pressure ramp) after therapy end in the morning, a feature called softSTOPP, which can configured in prismaVENT NIV devices. This could also improve therapy adherence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Noninvasive Ventilation, Dyspnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

softSTOPP active

Arm Type

Active Comparator

Arm Title

softSTOPP inactive

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

softSTOPP

Intervention Description

Non-invasive ventilation device setting in prismaVENT 30 device enabling an inverse pressure ramp after therapy end

Primary Outcome Measure Information:

Title

Change of dyspnea level from baseline to 12 weeks

Description

Delta value of morning dyspnea from baseline to 12 weeks as measured by the Borg Scale. The Borg Scale ranges from 0 (no perceived dyspnea at all) to 10 (maximum perceived dyspnea).

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years Diagnosis of a chronic obstructive pulmonary disease (COPD) with chronic hypercapnic insufficiency Therapy with prismaVENT 30, firmware V 3.3 or higher, mode S/T, stable device settings at the time of inclusion without need to adapt ventilation parameters May have co-existing obstructive sleep apnea syndrome Subjective dyspnea ≥3 (Borg scale) after end of ventilation therapy in the morning Written informed consent for study participation including data protection Exclusion Criteria: Missing written informed consent for study participation including data protection Contraindication for positive airway pressure therapy Use of the softSTOPP feature before study inclusion Participation in another study, which influences NIV therapy by defining device settings or titration Concomitant oxygen therapy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marcel Treml, Dr.

Phone

+4921263

Ext

6661

marcel.treml@klinik-bethanien.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Winfried J Randerath, Prof. Dr.

Organizational Affiliation

Krankenhaus Bethanien

Official's Role

Principal Investigator

Facility Information:

Facility Name

Krankenhaus Bethanien

City

Solingen

State/Province

NRW

ZIP/Postal Code

42699

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marcel Treml, Dr.

Phone

+4921263

Ext

6661

marcel.treml@klinik-bethanien.de

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Influence of an Inverse Pressure Ramp in Long-term Non-invasive Ventilation on Dyspnea in the Morning After Therapy

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