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

Sleep Apnea Syndromes Clinical Trial

Official title:

Untersuchung Der Übereinstimmung Der Ereigniserkennung Von "prismaLine" Geräten Mit Der Polysomnographie

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04407949
• Other study ID #: EventLab
• Status: Completed
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Institut für Pneumologie Hagen Ambrock eV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 30, 2020
• Est. primary completion date: June 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea Syndromes

Intervention

Other:
• CPAP Treatment
Comparing events from the CPAP device with the events scored in PSG

Locations

Country	Name	City	State
Germany	Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft gGmbH	Essen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pneumologie Hagen Ambrock eV	Heinen und Löwenstein GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	apnea- hypopnea- index (AHI)	Total number (N) and index (N/h) of sleep disordered breathing events (apnoeas plus hypopneas) from PSG and device log	up to 8 hours
Secondary	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.	up to 8 hours
Secondary	central and obstructive hypopnea index	total number (N) and Index (N/h) of hypopneas scored under AASM criteria for central and obstructive hypopneas.	up to 8 hours