Humidity Under Continuous Positive Airway Pressure

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: CPAP without humidification; Device: RESMed S9 with humidifier H5i and heated tube Climate Line; Device: CPAP with heated humidification

• Registration Number: NCT01462409
• Lead Sponsor: Institut für Pneumologie Hagen Ambrock eV

Brief 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.

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-10-20
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-31
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-17
• Last Update Posted: 2012-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No Humidification	CPAP without humidification	-
Controlled heated Humidification with heated tube	RESMed S9 with humidifier H5i and heated tube Climate Line	-
heated humidification	CPAP with heated humidification	-

Primary Outcome Measures

Name	Time	Method
Humidity differences	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.

Trial Locations

Locations (1)

Helios Klinik Hagen Ambrock; 🇩🇪 Hagen, NRW, Germany