TerminatedNCT04093427Updated Dec 21, 2023

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

An interventional study of softSTOPP in Noninvasive Ventilation and Dyspnea, sponsored by Wissenschaftliches Institut Bethanien e.V. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-21.

Sponsored by Wissenschaftliches Institut Bethanien e.V · Not applicable, Interventional, and Treatment

Why this study was terminated

Insufficient recruitment in a timely manner

Phase: Not applicable
Study type: Interventional
Enrollment: 8
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Noninvasive Ventilation
Dyspnea

Browse trials for

Dyspnea 656

In context

Dyspnea

656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.

This study's enrollment of 8 is below the median of 48 across 430 interventional studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

Wissenschaftliches Institut Bethanien e.V is the lead sponsor of 25 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 8 participants (actual)

Study arms

Active comparator
softSTOPP active
Other: softSTOPP
No intervention
softSTOPP inactive

Interventions

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

What researchers measure

Primary outcomes

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).
Time frame: 12 weeks

Study locations

1 site

Krankenhaus Bethanien
Solingen, NRW 42699, Germany

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04093427
Lead sponsor: Wissenschaftliches Institut Bethanien e.V
Collaborators: Löwenstein Medical Technology GmbH & Co. KG
Responsible party: Sponsor
First posted: Sep 18, 2019
Start date: Aug 1, 2019
Primary completion: Jul 31, 2022
Completion: Jul 31, 2022
Last update: Dec 21, 2023

Study contacts

Winfried J Randerath, Prof. Dr.

principal investigator · Krankenhaus Bethanien

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Dyspnea→

Other studies from this sponsor

Wissenschaftliches Institut Bethanien e.V

Start the discussion