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

NCT04407949 | Completed

• 1 other identifier: EventLab
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Sleep Apnea Syndromes

Keywords

CPAP; Apnea; Hypopnea; event detection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• hypopnea index relating to oxygen desaturation

  up to 8 hours

• central and obstructive hypopnea index

  up to 8 hours

Study Arms (1)

event detection

OTHER

Other: CPAP Treatment

Interventions

CPAP Treatment OTHER

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

Also known as: PrismaLine

event detection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PSG diagnostic not older than 3 month,
• AHI\>15, CPAP indication,
• age \>18,
• nasal CPAP mask,
• written informed consent

You may not qualify if:

• CPAP contraindication,
• participation in another clinical trial

Sponsors & Collaborators

• Institut für Pneumologie Hagen Ambrock eV: lead
• Heinen und Löwenstein GmbH & Co. KG: collaborator

Study Sites (1)

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

Essen, North Rhine-Westphalia, 45276, Germany

Location

Related Publications (1)

• Richter M, Schroeder M, Domanski U, Schwaibold M, Nilius G. Reliability of respiratory event detection with continuous positive airway pressure in moderate to severe obstructive sleep apnea - comparison of polysomnography with a device-based analysis. Sleep Breath. 2023 Aug;27(4):1639-1650. doi: 10.1007/s11325-022-02740-w. Epub 2022 Nov 17.

  PMID: 36394692 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Apnea

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Georg Nilius, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical director of pneumologic department

Model Details: Every enrolled patient underwent a CPAP - Titration under PSG with predefined pressure steps. Afterwards breathing events are scored manually based on AASM Criteria by a trained study member. The events will be compared with the readout from the CPAP Device.

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: May 29, 2020
• Study Start: January 17, 2019
• Primary Completion: June 8, 2020
• Study Completion: September 30, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)