Humidity Under Continuous Positive Airway Pressure

September 17, 2012 updated by: Institut für Pneumologie Hagen Ambrock eV

Luftfeuchtigkeit Unter CPAP Mit Temperatur- Und Feuchtigkeitskontrolle

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will breath 3 hours during daytime with a nasal mask under three different humidity modes (No humidity, controlled heated humidification, controlled heated humidification with heated tubing) with CPAP 8 and 12 mmHg and with and without leakage. The ambient room temperature is controlled with air conditioning. Changes in temperature and humidity is measured inside of the mask with a humidity sensor and recorded. After each phase the participants subjective opinion about humidity and temperature is asked.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Hagen, NRW, Germany, 58091
        • Helios Klinik Hagen Ambrock

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age 20-70
  • Obstructive Sleep Apnoea Syndrome

Exclusion Criteria:

  • Other severe acute or chronic nasal disease (rhinitis, sinusitis), Cardiovascular disease, respiratory or neurologic disease
  • Incapable of giving consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: heated 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.
Other Names:
  • RESMed S9 with humidifier H5i
Experimental: No Humidification
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.
Other Names:
  • ResMed S9 without humidifier
Experimental: Controlled heated Humidification with heated tube
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Humidity differences
Time Frame: 3 hours per patient
Changes of humidity and temperature under different conditions (e.g. with and without humidifier, leakage, pressure changes) measured breath by breath with humditiy sensor inside of a nasal mask.
3 hours per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut für Pneumologie Hagen Ambrock eV

Collaborators

ResMed GmbH & Co KG

Investigators

  • Principal Investigator: Karl Heinz Ruehle, MD, Institut für Pneumologie Hagen Ambrock eV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 31, 2011

Study Record Updates

Last Update Posted (Estimate)

September 18, 2012

Last Update Submitted That Met QC Criteria

September 17, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Climateline2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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