Effects of Humidity (During CPAP Treatment) on Mucociliary Clearance in Patients With Obstructive Sleep Apnea
CIA-6
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
1 other identifier
interventional
4
1 country
1
Brief Summary
That the level of humidification delivered to patients during CPAP treatment will alter the subjects mucociliary clearance rate and related mucus properties.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2008
Shorter than P25 for not_applicable
1 active site
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
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 11, 2008
CompletedFirst Posted
Study publicly available on registry
November 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2009
CompletedApril 27, 2018
June 1, 2009
9 months
November 11, 2008
April 25, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
mucociliary clearance.
pre and post cpap treatment with varying levels of humidity
Study Arms (3)
CPAP + ThermoSmart™ humidity
ACTIVE COMPARATORCPAP + Conventional humidity
ACTIVE COMPARATORCPAP + No added humidity
ACTIVE COMPARATORInterventions
an absolute humidity (AH) of 28 mg/l +/- 2mg/l
an absolute humidity (AH) of 18 mg/l +/- 2 mg/l
Eligibility Criteria
You may qualify if:
- Moderate to severe obstructive sleep apnea - Apnea Hypopnea Index (AHI) \> 15
- % of events during the diagnostic study must be obstructive
You may not qualify if:
- 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
- Acute upper airway disease
- Smoker
- COPD
- Congestive heart failure
- Neuromuscular disease
- Stroke
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital
São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geraldo Lorenzi, MD
Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital
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
November 11, 2008
First Posted
November 13, 2008
Study Start
October 1, 2008
Primary Completion
June 24, 2009
Study Completion
June 24, 2009
Last Updated
April 27, 2018
Record last verified: 2009-06