Obstructive Sleep ApneaCIA-6NCT00790166
Effects of Humidity (During CPAP Treatment) on Mucociliary Clearance in Patients With Obstructive Sleep Apnea
A study testing CPAP + ThermoSmart™ humidity, CPAP + Conventional humidity and CPAP + No added humidity in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in Brazil.
Trial summary
That the level of humidification delivered to patients during CPAP treatment will alter the subjects mucociliary clearance rate and related mucus properties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP + ThermoSmart™ humidity, CPAP + Conventional humidity and CPAP + No added humidity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2008to 24 Jun 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe obstructive sleep apnea - Apnea Hypopnea Index (AHI) > 15
- 75% of events during the diagnostic study must be obstructive
Who cannot join
- Currently using CPAP treatment OR have used it in the past 4 weeks
- Intolerance of CPAP and/or CPAP mask in the past or during the titration night
- Mouth breather (unable to breath through mouth for the study period)
- < 18years old
- Nasal CPAP intolerance determined in the PSG-CPAP titration study
- Serious nasal issues
Show all 12Show fewer
- Acute upper airway disease
- Smoker
- COPD
- Congestive heart failure
- Neuromuscular disease
- Stroke
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital
São Paulo
About this study
Official title: Effects of nCPAP With and Without Humidification on: Inspiratory Temperature, Humidity, Saccharine Transit Time, Nasal Lavage and in Vitro Mucus Properties in Patients With Obstructive Sleep Apnea
That the level of humidification delivered to patients during CPAP treatment will alter the subjects mucociliary clearance rate and related mucus properties.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP + ThermoSmart™ humidity, CPAP + Conventional humidity, CPAP + No added humidity
- 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.
CPAP + ThermoSmart™ humidityDevice
an absolute humidity (AH) of 28 mg/l +/- 2mg/l
CPAP + Conventional humidityDevice
an absolute humidity (AH) of 18 mg/l +/- 2 mg/l
CPAP + No added humidityDevice
ambient humidity
| Study group | Role | What they receive |
|---|---|---|
| CPAP + ThermoSmart™ humidity | Active comparator | Not described Receives: Device: CPAP + ThermoSmart™ humidity |
| CPAP + Conventional humidity | Active comparator | Not described Receives: Device: CPAP + Conventional humidity |
| CPAP + No added humidity | Active comparator | Not described Receives: Device: CPAP + No added humidity |
What is being measured
The primary outcome is the main question the study is designed to answer.
mucociliary clearance.
Measured: pre and post cpap treatment with varying levels of humidity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startOct 2008
- Primary completion24 Jun 2009
- Study completion24 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geraldo Lorenzi, MD, Principal investigator, Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790166
- Sponsor's protocol ID
- OSA CPAP,ThemoSmartMCC, Brasil
- Acronym
- CIA-6
- Status last verified
- Jun 2009
- First submitted
- 11 Nov 2008
- Last updated
- 27 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of nCPAP With and Without Humidification on: Inspiratory Temperature, Humidity, Saccharine Transit Time, Nasal Lavage and in Vitro Mucus Properties in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00790166
- Acronym / sponsor ID
- CIA-6 / OSA CPAP,ThemoSmartMCC, Brasil
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- 24 Jun 2009 (actual)
- Study completion
- 24 Jun 2009 (actual)
- First posted
- 13 Nov 2008 (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.
That the level of humidification delivered to patients during CPAP treatment will alter the subjects mucociliary clearance rate and related mucus properties.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPAP + ThermoSmart™ humidity | Active comparator | Device: CPAP + ThermoSmart™ humidity |
| CPAP + Conventional humidity | Active comparator | Device: CPAP + Conventional humidity |
| CPAP + No added humidity | Active comparator | Device: CPAP + No added humidity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate to severe obstructive sleep apnea - Apnea Hypopnea Index (AHI) > 15
- 75% of events during the diagnostic study must be obstructive
Key exclusion criteria (12 listed)
- Currently using CPAP treatment OR have used it in the past 4 weeks
- Intolerance of CPAP and/or CPAP mask in the past or during the titration night
- Mouth breather (unable to breath through mouth for the study period)
- < 18years old
- Nasal CPAP intolerance determined in the PSG-CPAP titration study
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 |
|---|---|---|
| CPAP + ThermoSmart™ humidityan absolute humidity (AH) of 28 mg/l +/- 2mg/l | Device | CPAP + ThermoSmart™ humidity |
| CPAP + Conventional humidityan absolute humidity (AH) of 18 mg/l +/- 2 mg/l | Device | CPAP + Conventional humidity |
| CPAP + No added humidityambient humidity | Device | CPAP + No added humidity |
Primary outcome
mucociliary clearance.
Time frame: pre and post cpap treatment with varying levels of humidity
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
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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.
Geraldo Lorenzi, MD principal investigator
Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP + ThermoSmart™ humidity, CPAP + Conventional humidity and CPAP + No added humidity in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in Brazil.
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 12 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: stopped early, as of the sponsor's last update on 27 Apr 2018. 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 Brazil. 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 was stopped early. Results are not available in the source record.
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?
mucociliary clearance. (time frame: pre and post cpap treatment with varying levels of humidity). 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 27 Apr 2018.