Study Stopped
Insufficient recruitment in a timely manner
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.
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
September 16, 2019
CompletedFirst Posted
Study publicly available on registry
September 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedDecember 21, 2023
December 1, 2023
3 years
September 16, 2019
December 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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).
12 weeks
Study Arms (2)
softSTOPP active
ACTIVE COMPARATORsoftSTOPP inactive
NO INTERVENTIONInterventions
Non-invasive ventilation device setting in prismaVENT 30 device enabling an inverse pressure ramp after therapy end
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Diagnosis of a chronic obstructive pulmonary disease (COPD) with chronic hypercapnic insufficiency
- 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
You may not qualify if:
- Missing written informed consent for study participation including data protection
- Contraindication for positive airway pressure therapy
- Participation in another study, which influences NIV therapy by defining device settings or titration
- Concomitant oxygen therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Krankenhaus Bethanien
Solingen, North Rhine-Westphalia, 42699, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Winfried J Randerath, Prof. Dr.
Krankenhaus Bethanien
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2019
First Posted
September 18, 2019
Study Start
August 1, 2019
Primary Completion
July 31, 2022
Study Completion
July 31, 2022
Last Updated
December 21, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share