Extended validation of the auto-Bi/TriLevel therapy modes prismaLINE

Extended validation of the auto-Bi/TriLevel therapy modes prismaLINE - prismaLINE auto-Bi/TriLevel Studie

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007994

Enrollment

Registered

2015-06-11

Start date

2015-04-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Related Breathing Disorders (SRBDs), Patients with the indication for first-time initiation of BiLevel therapy. G47.3

Interventions

Group 1: Application of the TriLevel pressure profile during one half (split-night) of a treatment night with polysomnography in a sleep laboratory. Group 2: Application of the BiLevel pressure profil

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of obstructive, mixed or complex sleep apnea; indication for first-time initiation of BiLevel therapy within clinical routine, time to first time diagnosis = 6 months; Age = 18 years; signed informed consent

Exclusion criteria

Exclusion criteria: Missing signed informed consent form; Concurrent participation in another study that influences the initiation of BiLevel therapy by specifications of device settings or titration procedure; Acute cardiac decompensation; Severe arrhythmia; Severe hypotension, particularly in combination with intravascular volume depletion; Severe epistaxis; High risk of barotrauma; Severe chronic/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; In each case the decision whether to use this therapy device lies with the doctor in charge.

Design outcomes

Primary

Measure	Time frame
Primary outcome parameters for the evaluation of therapeutic efficacy of the auto-Bi-/TriLevel therapy night are the apnea-hypopnea index (AHI) and the percentage of total sleep time (TST) with an oxygen Saturation < 90% (SpO2<90% in %TST).	—

Secondary

Measure	Time frame
Outcome parameters of the split-night comparison of the Bi- and TriLevel pressure profile are the obstructive apnea index (oAI) and the percentage of total sleep time (TST) with an oxygen saturation < 90% (SpO2<90% in %TST). In addition the following outcome parameters are of relevance for the comparison: tidal volume, breaths per minute (bpm), pressure parameters (IPAP, EEPAP, EPAP), leakage and relative inspiration time (Ti/T). The outcome parameters and laboratory reports regarding evtl. manual changes of therapeutic parameters will provide information regarding the comparison of the Bi- and TriLevel pressure profile.	—

Measure

Time frame

Outcome parameters of the split-night comparison of the Bi- and TriLevel pressure profile are the obstructive apnea index (oAI) and the percentage of total sleep time (TST) with an oxygen saturation < 90% (SpO2<90% in %TST). In addition the following outcome parameters are of relevance for the comparison: tidal volume, breaths per minute (bpm), pressure parameters (IPAP, EEPAP, EPAP), leakage and relative inspiration time (Ti/T). The outcome parameters and laboratory reports regarding evtl. manual changes of therapeutic parameters will provide information regarding the comparison of the Bi- and TriLevel pressure profile.

—

Countries

Germany

Contacts

Public ContactUlrike Domanski

Pneumologisches InstitutHELIOS Klinik Hagen

ulrike.domanski@helios-kliniken.de+49 2331 974 2080

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026