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OpenTrials
Completed

NCT Number: NCT01462409

Humidity Under Continuous Positive Airway Pressure

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.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, 58091, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RESMed S9 with humidifier H5i and heated tube Climate Line

Device

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

Device

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

CPAP with heated humidification

Device

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Institut für Pneumologie Hagen Ambrock eV

Industry

Collaborators

  • ResMed GmbH & Co KG

Registry information

Official study title

Luftfeuchtigkeit Unter CPAP Mit Temperatur- Und Feuchtigkeitskontrolle

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 31, 2011
Registry last updated
Sep 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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