Humidity Under Continuous Positive Airway Pressure

Sleep Apnea, Obstructive Clinical Trial

Official title:

Luftfeuchtigkeit Unter CPAP Mit Temperatur- Und Feuchtigkeitskontrolle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462409
• Other study ID #: Climateline2011
• Status: Completed
• Phase: N/A
• First received: October 20, 2011
• Last updated: September 17, 2012
• Start date: March 2011
• Est. completion date: January 2012

Study information

• Verified date: September 2012
• Source: Institut für Pneumologie Hagen Ambrock eV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

Intervention

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).
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Helios Klinik Hagen Ambrock	Hagen	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pneumologie Hagen Ambrock eV	ResMed GmbH & Co KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Humidity differences	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	No