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

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.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04093427

Enrollment

Registered

2019-09-18

Start date

2019-08-01

Completion date

2022-07-31

Last updated

2023-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea, Noninvasive Ventilation

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.

Interventions

OTHERsoftSTOPP

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Change of dyspnea level from baseline to 12 weeks	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).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026