Influence of an Inverse Pressure Ramp in Long-term Non-in... | NCT04093427

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

NCT04093427

Sponsor

Wissenschaftliches Institut Bethanien e.V

Status

Terminated

Last Update Posted

Dec 21, 2023Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Noninvasive Ventilation
Dyspnea

Interventions

softSTOPP

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient recruitment in a timely manner

Expanded Access Info

Start Date

Aug 1, 2019Actual

Primary Completion Date

Jul 31, 2022Actual

Completion Date

Jul 31, 2022Actual

First Submitted Date

Sep 16, 2019

First Submission Date that Met QC Criteria

Sep 16, 2019

First Posted Date

Sep 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2023

Last Update Posted Date

Dec 21, 2023Actual

Name	Class
Löwenstein Medical Technology GmbH & Co. KG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
softSTOPP active	Active Comparator		Other: softSTOPP
softSTOPP inactive	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
softSTOPP	Other	Non-invasive ventilation device setting in prismaVENT 30 device enabling an inverse pressure ramp after therapy end	softSTOPP active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Winfried J Randerath, Prof. Dr.	Krankenhaus Bethanien	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Krankenhaus Bethanien		Solingen	North Rhine-Westphalia	42699	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004417	Dyspnea

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided