Sleep Apnea, ObstructiveNCT01462409
Humidity Under Continuous Positive Airway Pressure
A study testing RESMed S9 with humidifier H5i and heated tube Climate Line, CPAP without humidification and CPAP with heated humidification in people with Sleep Apnea, Obstructive, run by Institut für Pneumologie Hagen Ambrock eV at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men only
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- RESMed S9 with humidifier H5i and heated tube Climate Line, CPAP without humidification and CPAP with heated humidification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-70
- Obstructive Sleep Apnoea Syndrome
Who cannot join
- Other severe acute or chronic nasal disease (rhinitis, sinusitis), Cardiovascular disease, respiratory or neurologic disease
- Incapable of giving consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Helios Klinik Hagen Ambrock
Hagen, North Rhine-Westphalia, 58091
About this study
Official title: Luftfeuchtigkeit Unter CPAP Mit Temperatur- Und Feuchtigkeitskontrolle
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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- RESMed S9 with humidifier H5i and heated tube Climate Line, CPAP without humidification, CPAP with heated humidification
- Keywords
- obstructive sleep apnea, humidification, mask, heated tubing
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
CPAP without humidificationDevice
Also called ResMed S9 without humidifier
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.
CPAP with heated humidificationDevice
Also called RESMed S9 with humidifier H5i
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.
| Study group | Role | What they receive |
|---|---|---|
| heated humidification | Experimental | Not described Receives: Device: CPAP with heated humidification |
| No Humidification | Experimental | Not described Receives: Device: CPAP without humidification |
| Controlled heated Humidification with heated tube | Experimental | Not described Receives: Device: RESMed S9 with humidifier H5i and heated tube Climate Line |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 hours per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startMar 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ResMed GmbH & Co KG
- Responsible party
- Sponsor
- Investigators
- Karl Heinz Ruehle, MD, Principal investigator, Institut für Pneumologie Hagen Ambrock eV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462409
- Sponsor's protocol ID
- Climateline2011
- Status last verified
- Sep 2012
- First submitted
- 20 Oct 2011
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Luftfeuchtigkeit Unter CPAP Mit Temperatur- Und Feuchtigkeitskontrolle
- ClinicalTrials.gov ID
- NCT01462409
- Acronym / sponsor ID
- Climateline2011
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- obstructive sleep apnea, humidification, mask, heated tubing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Institut für Pneumologie Hagen Ambrock eVIndustry (pharma, biotech, devices)
- Collaborators
- ResMed GmbH & Co KG
- Study start
- Mar 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 31 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 20-70
- Obstructive Sleep Apnoea Syndrome
Key exclusion criteria (2 listed)
- Other severe acute or chronic nasal disease (rhinitis, sinusitis), Cardiovascular disease, respiratory or neurologic disease
- Incapable of giving consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESMed S9 with humidifier H5i and heated tube Climate LineAt 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). | Device | Controlled heated Humidification with heated tube |
| CPAP without humidificationAlso: ResMed S9 without humidifierAt 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. | Device | No Humidification |
| CPAP with heated humidificationAlso: RESMed S9 with humidifier H5iAt 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. | Device | heated humidification |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Heinz Ruehle, MD principal investigator
Institut für Pneumologie Hagen Ambrock eV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESMed S9 with humidifier H5i and heated tube Climate Line, CPAP without humidification and CPAP with heated humidification in people with Sleep Apnea, Obstructive, run by Institut für Pneumologie Hagen Ambrock eV at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humidity differences (time frame: 3 hours per patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2012.