Humidity Under Continuous Positive Airway Pressure

Overview

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.

Full Title of Study: “Luftfeuchtigkeit Unter CPAP Mit Temperatur- Und Feuchtigkeitskontrolle”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Participant)
• Study Primary Completion Date: January 2012

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.

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.

Arms, Groups and Cohorts

• Experimental: heated humidification
• Experimental: No Humidification
• Experimental: Controlled heated Humidification with heated tube

Clinical Trial Outcome Measures

Primary Measures

• 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.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Institut für Pneumologie Hagen Ambrock eV
• Collaborator
  • ResMed GmbH & Co KG
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Karl Heinz Ruehle, MD, Principal Investigator, Institut für Pneumologie Hagen Ambrock eV