Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Application of Forced Breath Technique While CPAP Therapy for Apnea Classification (FBT-CPAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03432910
Recruitment Status : Unknown
Verified February 2018 by Heinen und Löwenstein GmbH & Co. KG.
Recruitment status was:  Recruiting
First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
Löwenstein Medical Technology
Information provided by (Responsible Party):
Heinen und Löwenstein GmbH & Co. KG

Brief Summary:

This study analyzes the application of the Forced Breath Technique (FBT) to classify apneas during CPAP therapy with a prismaLAB (device name) therapy device.

In this study the BiLevel ST (Spontaneous / Timed) therapy mode of the prismaLAB device is reduced to a CPAP pressure profile with exhalation relief by minimization of the pressure gap between exhalation and inhalation pressure.

The FBT based apnea classification of the devices firmware is matched with the by hand scoring of the polysomnographic data that is usually used to evaluate the quality of patients sleep.


Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Sleep Apnea, Central Other: CPAP Titration using a Bilevel S/T mode with minimal pressure support and background rate Not Applicable

Detailed Description:

Obstructive sleep-disordered breathing is usually treated by positive airway pressure (PAP) therapy with respective devices.The devices detect, classify and store respiratory events as apneas, hypopneas and snoring to adapt the therapy pressure according to patients needs and/ or to validate therapy efficacy.

Since several years the Forced Breath Technique (FBT) is standard practice in PAP devices with a BiLevel pressure profile and a background rate to classify apneas as central or obstructive. In case of an interruption of the respiratory flow within an apnea the devices background rate applies so called "mandatory breaths" with neither a manually or by device defined pressure gap between exhalation and inhalation pressure (PDIFF). If a mandatory breath generates respiratory flow patients airways are open and the patient gets ventilated. In this case the detected apnea is classified as central. If a mandatory breath generates no or insufficient respiratory flow patients airways are impassable and the apnea is classified as an obstructive event.

Usually the size of the applied therapeutic pressure gap PDIFF is >= 4 hPa. If patients airways are open the mandatory breaths with PDIFF>= 4 hPa generate an obvious flow that submits a valid classification of apneas. Therefore the pressure gap should be preferably large. So, too, the pressure gap size should be defined as small as possible to prevent the impairment of patients sleep quality.

This pilot study targets to analyze if the application of FBT with a minor gap between inhalation and exhalation pressure (IPAP [inspiratory positive airway pressure] - EPAP [expiratory positive airway pressure] = PDIFF = 1,0 to 2,0 hPa) qualifies for an equal classification of apneas as with a PDIFF >= 4 hPa. Subsequently it serves to define the minimum size of this pressure gap.

To this effect the study is subdivided in to phases: an optimization phase and an evaluation phase.

The optimization phase targets to define the PDIFF size that enables the valid classification of apneas. The evaluation phase serves to compute the accuracy of the classification, the optimized algorithm and the determined classification criteria. Therefore this phase only takes place if the optimization phase yielded a result.

The optimization phase starts with a PDIFF of 1,5 hPa. If this PDIFF serves the purpose, the phase continues with a PDIFF of 1,0 hPa to analyze if a smaller pressure gap yields similar results. Otherwise the phase continues with a PDIFF of 2,0 hPa. Afterwards the optimization phase ends.

The review of the matching of the apneas classified by the device vs the manual scoring takes place after the synchronization of both sources.

Within every PDIFF round in the optimization phase patient recruitment takes place as long as at least 60 obstructive and 60 central apneas have been collected. To guarantee an equal dispersion of apneas on the patient population only 10 obstructive and 10 central apneas of each patient go down in the pool of apneas of the respective PDIFF round. The apnea extraction is made by randomization.

The evaluation phase runs with the determined PDIFF until at least 80 obstructive and 80 central apneas are collected.

The data evaluation occurs by use of descriptive statistics and based on fourfold tables.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Application of Forced Breath Technique While CPAP Therapy for Apnea Classification
Actual Study Start Date : March 24, 2016
Estimated Primary Completion Date : February 23, 2018
Estimated Study Completion Date : March 29, 2018

Arm Intervention/treatment
treatment group
Participants of the study undergo the standard stages of the clinical routine within a PAP therapy setting: a diagnostic night followed by one or two treatment nights.
Other: CPAP Titration using a Bilevel S/T mode with minimal pressure support and background rate
The study performs within clinical routine with this exception that instead of the usually applied CPAP mode a modified BiLevel S/T mode is used. The modified BiLevel S/T mode meets the same requirements as the CPAP mode while providing the Forced Breath Technique to classify apneas as central or obstructive.




Primary Outcome Measures :
  1. Accuracy of the mapping of apneas based on the Forced Breath Technique compared to the manual scoring of polysomnographic data [ Time Frame: 1 night (= first treatment night) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of sleep-disordered breathing (AHI >= 15/h)
  • ensued or indicated CPAP titration within a routine PAP therapy setting
  • age >= 18 years
  • presence of written informed consent
  • in case of therapy control or repeated participation: total number of apneas in the ensued treatment night was > 10

Exclusion Criteria:

  • written informed consent is missing
  • Participation in another clinical trial that influences the initiation of (auto) CPAP treatment by specifications of device settings or titration procedure
  • NYHA (New York Heart Association) class III or IV
  • acute cardiac decompensation
  • severe arrhythmia
  • severe hypotension, particularly in combination with intravascular volume depletion
  • severe epistaxis
  • high risk of barotrauma
  • decompensated pulmonary conditions
  • pneumothorax or pneumomediastinum
  • pneumocephalus
  • cranial trauma
  • status following brain surgery or surgical intervention on the pituitary gland or the middle/inner ear
  • acute sinus infection (sinusitis), middle ear infection (otitis media) or perforated eardrum
  • dehydration

Exclusion Criteria Statistical Evaluation:

Data of patients who completed the study protocol will be excluded from statistical analysis if one of the following criteria applies:

  • there is leakage of > 50 l/min for
  • application of incorrect device settings
  • insufficient data quality of PSG (Polysomnography) -acquisition
  • the device was applied outside range of indication
  • data of diagnostic night are not acquired as a PSG
  • informed consent isn´t present
  • the total number of apneas during the treatment night with BiLevel ST is < 10

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432910


Contacts
Layout table for location contacts
Contact: Regina Schaefer +49 721-82830-23 regina.schaefer@loewensteinmedical.de
Contact: Matthias Schwaibold + 49 721-82830-49 matthias.schwaibold@loewensteinmedical.de

Locations
Layout table for location information
Germany
HELIOS Klinik Recruiting
Hagen, NRW, Germany, 58091
Contact: Ulrike Domanski         
Sponsors and Collaborators
Heinen und Löwenstein GmbH & Co. KG
Löwenstein Medical Technology
Investigators
Layout table for investigator information
Principal Investigator: Georg Nilius, PD Dr. med. HELIOS Klinik Hagen Ambrock
Layout table for additonal information
Responsible Party: Heinen und Löwenstein GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT03432910    
Other Study ID Numbers: 17-pLINE-FBT-C
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heinen und Löwenstein GmbH & Co. KG:
Forced Breath Technique
auto-CPAP
CPAP
Obstructive sleep apnea
central sleep apnea
Additional relevant MeSH terms:
Layout table for MeSH terms
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Apnea, Central
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases