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Humidity Under Continuous Positive Airway Pressure

This study has been completed.
Sponsor:
Collaborator:
ResMed GmbH & Co KG
Information provided by (Responsible Party):
Institut für Pneumologie Hagen Ambrock eV
ClinicalTrials.gov Identifier:
NCT01462409
First received: October 20, 2011
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Sleep Apnea, Obstructive
 Device: RESMed S9 with humidifier H5i and heated tube Climate Line
Device: CPAP without humidification
Device: CPAP with heated humidification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Luftfeuchtigkeit Unter CPAP Mit Temperatur- Und Feuchtigkeitskontrolle

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Institut für Pneumologie Hagen Ambrock eV:

Primary Outcome Measures:
  • Humidity differences [ Time Frame: 3 hours per patient ] [ Designated as safety issue: No ]
    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.


Enrollment: 19
Study Start Date: March 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: heated 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.
Other Name: RESMed S9 with humidifier H5i
Experimental: No Humidification 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.
Other Name: ResMed S9 without humidifier
Experimental: Controlled heated Humidification with heated tube 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).
Other Name: RESMed S9 with humidifier H5i and heated tube Climate Line

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462409

Locations
Germany
Helios Klinik Hagen Ambrock
Hagen, NRW, Germany, 58091
Sponsors and Collaborators
Institut für Pneumologie Hagen Ambrock eV
ResMed GmbH & Co KG
Investigators
Principal Investigator: Karl Heinz Ruehle, MD Institut für Pneumologie Hagen Ambrock eV
  More Information

No publications provided

Responsible Party: Institut für Pneumologie Hagen Ambrock eV
ClinicalTrials.gov Identifier: NCT01462409     History of Changes
Other Study ID Numbers: Climateline2011
Study First Received: October 20, 2011
Last Updated: September 17, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Institut für Pneumologie Hagen Ambrock eV:
obstructive sleep apnea
humidification
mask
heated tubing

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 13, 2013