Noninvasive VentilationNCT04093427
Influence of an Inverse Pressure Ramp in Long-term Non-invasive Ventilation on Dyspnea in the Morning After Therapy
A study testing softSTOPP in people with Noninvasive Ventilation and Dyspnea, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninvasive Ventilation, Dyspnea
- What is being tested?
- softSTOPP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2019to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Noninvasive Ventilation, Dyspnea
- Being tested
- softSTOPP
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
softSTOPPOther
Non-invasive ventilation device setting in prismaVENT 30 device enabling an inverse pressure ramp after therapy end
| Study group | Role | What they receive |
|---|---|---|
| softSTOPP active | Active comparator | Not described Receives: Other: softSTOPP |
| softSTOPP inactive | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Aug 2019
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Why it stopped: Insufficient recruitment in a timely manner
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noninvasive VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Collaborators
- Löwenstein Medical Technology GmbH & Co. KG
- Responsible party
- Sponsor
- Investigators
- Winfried J Randerath, Prof. Dr., Principal investigator, Krankenhaus Bethanien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093427
- Sponsor's protocol ID
- WI_19-090_softSTOPP
- Status last verified
- Dec 2023
- First submitted
- 16 Sep 2019
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04093427
- Acronym / sponsor ID
- WI_19-090_softSTOPP
- Conditions
- Noninvasive Ventilation, Dyspnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment in a timely manner
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Collaborators
- Löwenstein Medical Technology GmbH & Co. KG
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| softSTOPP active | Active comparator | Other: softSTOPP |
| softSTOPP inactive | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| softSTOPPNon-invasive ventilation device setting in prismaVENT 30 device enabling an inverse pressure ramp after therapy end | Other | softSTOPP active |
Primary outcome
Change of dyspnea level from baseline to 12 weeks
Time frame: 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).
Results and safety
The study was stopped early (reason given: Insufficient recruitment in a timely manner). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried J Randerath, Prof. Dr. principal investigator
Krankenhaus Bethanien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing softSTOPP in people with Noninvasive Ventilation and Dyspnea, run by Wissenschaftliches Institut Bethanien e.V at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment in a timely manner). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of dyspnea level from baseline to 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.