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Humidity Under Continuous Positive Airway Pressure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01462409
First Posted: October 31, 2011
Last Update Posted: September 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
ResMed GmbH & Co KG
Information provided by (Responsible Party):
Institut für Pneumologie Hagen Ambrock eV
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Luftfeuchtigkeit Unter CPAP Mit Temperatur- Und Feuchtigkeitskontrolle

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

Primary Outcome Measures:
  • 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.


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).

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Institut für Pneumologie Hagen Ambrock eV
ClinicalTrials.gov Identifier: NCT01462409     History of Changes
Other Study ID Numbers: Climateline2011
First Submitted: October 20, 2011
First Posted: October 31, 2011
Last Update Posted: September 18, 2012
Last Verified: September 2012

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

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