Humidity Under Continuous Positive Airway Pressure

Institut für Pneumologie Hagen Ambrock eV

Status: Completed

Conditions: Sleep Apnea, Obstructive

Treatments: Device: CPAP with heated humidification; Device: CPAP without humidification; Device: RESMed S9 with humidifier H5i and heated tube Climate Line

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01462409

Climateline2011

Details and patient eligibility

About

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 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.

Enrollment: 19 patients

Sex: Male

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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19 participants in 3 patient groups

heated humidification

Experimental group

Treatment:

Device: CPAP with heated humidification

No Humidification

Experimental group

Treatment:

Device: CPAP without humidification

Controlled heated Humidification with heated tube

Experimental group

Treatment:

Device: RESMed S9 with humidifier H5i and heated tube Climate Line