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Humidity Under Continuous Positive Airway Pressure

NCT01462409 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2012-09-18

No results posted yet for this study

Summary

Heated humidification in CPAP therapy is often not enough to prevent side effects like dryness of nasal mucosa and xerostomia, especially in cases of mouth breathing or mask leakage. Additionally a higher level of humidification in lower ambient room temperature can lead to condensation and irritating noises. Compliance of affected patients decreases considerably. Regarding this, devices with humidifier and additional heated tubing are developed to automatically regulate optimal humidification and temperature right up to the mask. The efficacy of a system with controlled heated humidification and heated tubing in nasal masks under various conditions like leakage and different pressure levels is object of this study.

Conditions

  • Sleep Apnea, Obstructive

Interventions

DEVICE

RESMed S9 with humidifier H5i and heated tube Climate Line

At stable ambient room temperature and different CPAP pressure levels, 8 and 12 cmH2O, with and without additional leakage, humidity and temperature is measured inside of a patients nasal mask. Controlled heated humidification with heated tubing (Climate Line).

DEVICE

CPAP without humidification

At stable ambient room temperature and different CPAP pressure levels, 8 and 12 cmH2O, with and without additional leakage, humidity and temperature is measured inside of a patients nasal mask. Without any humidification.

DEVICE

CPAP with heated humidification

At stable ambient room temperature and different CPAP pressure levels, 8 and 12 cmH2O, with and without additional leakage, humidity and temperature is measured inside of a patients nasal mask. With controlled heated humidification and standard tubing.

Sponsors & Collaborators

  • ResMed GmbH & Co KG

    collaborator UNKNOWN

  • Institut für Pneumologie Hagen Ambrock eV

    lead INDUSTRY

Principal Investigators

  • Karl Heinz Ruehle, MD · Institut für Pneumologie Hagen Ambrock eV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01462409 on ClinicalTrials.gov