Comparison of Sleep Disordered Breathing Events Detected by the CPAP Device "prismaLine" With Polysomnography

Institut für Pneumologie Hagen Ambrock eV70 enrolled

Overview

Evaluation of residual sleep disordered breathing (SDB) under continuous positive airway pressure (CPAP) therapy with comparison of the automatic detected SDB event indices from CPAP machines with manual scored polysomnography (PSG).

The evaluation of residual sleep disordered breathing (SDB) in sleep apnea (SA) after initiation of continuous positive airway pressure (CPAP) therapy is important to verify the therapeutic success. In clinical practice, the internal records of CPAP devices are utilized to determine the therapeutic success, during either medical consultations or telemetric observation. This study was designed to evaluate the quality of SDB Event Indices (EI), which are recorded by the CPAP device (Prisma, Löwenstein Medical Technology). The detected events of a manual scored polysomnography (PSG) in the sleep laboratory will be compared with the simultaneously recorded events of the CPAP device. This shall lead to recommendations regarding the situations, and in which degree the event detection of the CPAP devices may be meaningful to determine the therapeutic success of home sleep apnea therapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Sleep Apnea Syndromes

Interventions

CPAP TreatmentOTHER

Comparing events from the CPAP device with the events scored in PSG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * PSG diagnostic not older than 3 month, * AHI\>15, CPAP indication, * age \>18, * nasal CPAP mask, * written informed consent Exclusion Criteria: * CPAP contraindication, * participation in another clinical trial

Locations (1)

Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH

Essen, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

apnea- hypopnea- index (AHI)

Total number (N) and index (N/h) of sleep disordered breathing events (apnoeas plus hypopneas) from PSG and device log

Time frame: up to 8 hours

Secondary Outcomes

hypopnea index relating to oxygen desaturation

total number of Hypopneas (N) and Index (N/h) scored under AASM criteria for hypopneas, both rules. 1A: hypopnea events with \>= 3% oxygen desaturation and 1B: hypopnea events with \>= 4% oxygen desaturation.

Time frame: up to 8 hours

central and obstructive hypopnea index

total number (N) and Index (N/h) of hypopneas scored under AASM criteria for central and obstructive hypopneas.

Time frame: up to 8 hours

Data from ClinicalTrials.gov

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