NCT03432910

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 24, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2018

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

February 5, 2018

Last Update Submit

February 13, 2018

Conditions

Sleep Apnea, ObstructiveSleep Apnea, Central

Keywords

Forced Breath Techniqueauto-CPAPCPAPObstructive sleep apneacentral sleep apnea

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the mapping of apneas based on the Forced Breath Technique compared to the manual scoring of polysomnographic data

    1 night (= first treatment night)

Study Arms (1)

treatment group

OTHER

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

Interventions

CPAP Titration using a Bilevel S/T mode with minimal pressure support and background rateOTHER

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.

treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HELIOS Klinik

Hagen, North Rhine-Westphalia, 58091, Germany

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea, Central

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Georg Nilius, PD Dr. med.

    HELIOS Klinik Hagen Ambrock

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Regina Schaefer

CONTACT

+49 721-82830-23regina.schaefer@loewensteinmedical.de

Matthias Schwaibold

CONTACT

+ 49 721-82830-49matthias.schwaibold@loewensteinmedical.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 14, 2018

Study Start

March 24, 2016

Primary Completion

February 23, 2018

Study Completion

March 29, 2018

Last Updated

February 14, 2018

Record last verified: 2018-02

Locations

DE(1)