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

Sponsor

Wissenschaftliches Institut Bethanien e.V (Other)

Overall Status

Recruiting

CT.gov ID

NCT04093427

Collaborator

Löwenstein Medical Technology GmbH & Co. KG (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Noninvasive Ventilation Dyspnea	Other: softSTOPP	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: softSTOPP active	Other: softSTOPP Non-invasive ventilation device setting in prismaVENT 30 device enabling an inverse pressure ramp after therapy end
No Intervention: softSTOPP inactive

Arm

Intervention/Treatment

Active Comparator: softSTOPP active

Other: softSTOPP

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

No Intervention: softSTOPP inactive

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Krankenhaus Bethanien	Solingen	NRW	Germany	42699

Sponsors and Collaborators

Wissenschaftliches Institut Bethanien e.V
Löwenstein Medical Technology GmbH & Co. KG

Investigators

Principal Investigator: Winfried J Randerath, Prof. Dr., Krankenhaus Bethanien

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wissenschaftliches Institut Bethanien e.V

ClinicalTrials.gov Identifier:

NCT04093427

Other Study ID Numbers:

WI_19-090_softSTOPP

First Posted:

Sep 18, 2019

Last Update Posted:

Oct 7, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dyspnea

Study Results

No Results Posted as of Oct 7, 2021