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Humidity Under Continuous Positive Airway Pressure

NCT ID: NCT01462409

Last Updated: 2012-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-01-31

Brief Summary

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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

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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.

Conditions

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Sleep Apnea, Obstructive

Keywords

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obstructive sleep apnea humidification mask heated tubing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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heated humidification

Group Type EXPERIMENTAL

CPAP with heated humidification

Intervention Type 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.

No Humidification

Group Type EXPERIMENTAL

CPAP without humidification

Intervention Type 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.

Controlled heated Humidification with heated tube

Group Type EXPERIMENTAL

RESMed S9 with humidifier H5i and heated tube Climate Line

Intervention Type 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).

Interventions

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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).

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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ResMed S9 without humidifier RESMed S9 with humidifier H5i

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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ResMed GmbH & Co KG

UNKNOWN

Sponsor Role collaborator

Institut für Pneumologie Hagen Ambrock eV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl Heinz Ruehle, MD

Role: PRINCIPAL_INVESTIGATOR

Institut für Pneumologie Hagen Ambrock eV

Locations

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Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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Climateline2011

Identifier Type: -

Identifier Source: org_study_id