NCT01462409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

September 18, 2012

Status Verified

September 1, 2012

Enrollment Period

10 months

First QC Date

October 20, 2011

Last Update Submit

September 17, 2012

Conditions

Sleep Apnea, Obstructive

Keywords

obstructive sleep apneahumidificationmaskheated tubing

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 hours per patient

Study Arms (3)

heated humidification

EXPERIMENTAL
Device: CPAP with heated humidification

No Humidification

EXPERIMENTAL
Device: CPAP without humidification

Controlled heated Humidification with heated tube

EXPERIMENTAL
Device: RESMed S9 with humidifier H5i and heated tube Climate Line

Interventions

RESMed S9 with humidifier H5i and heated tube Climate LineDEVICE

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).

Controlled heated Humidification with heated tube
CPAP without humidificationDEVICE

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.

Also known as: ResMed S9 without humidifier
No Humidification
CPAP with heated humidificationDEVICE

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.

Also known as: RESMed S9 with humidifier H5i
heated humidification

Eligibility Criteria

Age20 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-70
  • Obstructive Sleep Apnoea Syndrome

You may not qualify if:

  • Other severe acute or chronic nasal disease (rhinitis, sinusitis), Cardiovascular disease, respiratory or neurologic disease
  • Incapable of giving consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helios Klinik Hagen Ambrock

Hagen, North Rhine-Westphalia, 58091, Germany

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway PressureHumidifiers

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory TherapyEquipment and SuppliesHousehold ArticlesTechnology, Industry, and Agriculture

Study Officials

  • Karl Heinz Ruehle, MD

    Institut für Pneumologie Hagen Ambrock eV

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2011

First Posted

October 31, 2011

Study Start

March 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

September 18, 2012

Record last verified: 2012-09

Locations

DE(1)