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Humidity Under Continuous Positive Airway Pressure

Primary Purpose

Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
RESMed S9 with humidifier H5i and heated tube Climate Line
CPAP without humidification
CPAP with heated humidification
Sponsored by
Institut für Pneumologie Hagen Ambrock eV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring obstructive sleep apnea, humidification, mask, heated tubing

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Helios Klinik Hagen Ambrock

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

heated humidification

No Humidification

Controlled heated Humidification with heated tube

Arm Description

Outcomes

Primary Outcome Measures

Humidity differences
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.

Secondary Outcome Measures

Full Information

First Posted
October 20, 2011
Last Updated
September 17, 2012
Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
ResMed GmbH & Co KG
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1. Study Identification

Unique Protocol Identification Number
NCT01462409
Brief Title
Humidity Under Continuous Positive Airway Pressure
Official Title
Luftfeuchtigkeit Unter CPAP Mit Temperatur- Und Feuchtigkeitskontrolle
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut für Pneumologie Hagen Ambrock eV
Collaborators
ResMed GmbH & Co KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
obstructive sleep apnea, humidification, mask, heated tubing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
heated humidification
Arm Type
Experimental
Arm Title
No Humidification
Arm Type
Experimental
Arm Title
Controlled heated Humidification with heated tube
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
RESMed S9 with humidifier H5i and heated tube Climate Line
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
CPAP without humidification
Other Intervention Name(s)
ResMed S9 without humidifier
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
CPAP with heated humidification
Other Intervention Name(s)
RESMed S9 with humidifier H5i
Intervention Description
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.
Primary Outcome Measure Information:
Title
Humidity differences
Description
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.
Time Frame
3 hours per patient

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Heinz Ruehle, MD
Organizational Affiliation
Institut für Pneumologie Hagen Ambrock eV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helios Klinik Hagen Ambrock
City
Hagen
State/Province
NRW
ZIP/Postal Code
58091
Country
Germany

12. IPD Sharing Statement

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Humidity Under Continuous Positive Airway Pressure

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