Status:
UNKNOWN
Application of Forced Breath Technique While CPAP Therapy for Apnea Classification
Lead Sponsor:
Heinen und Löwenstein GmbH & Co. KG
Collaborating Sponsors:
Löwenstein Medical Technology
Conditions:
Sleep Apnea, Obstructive
Sleep Apnea, Central
Eligibility:
All Genders
18+ years
Phase:
NA
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 (Spontaneou...
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, hypopne...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 24 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 29 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03432910
Start Date
March 24 2016
End Date
March 29 2018
Last Update
February 14 2018
Active Locations (1)
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1
HELIOS Klinik
Hagen, North Rhine-Westphalia, Germany, 58091