Effects of Humidity (During CPAP Treatment) on Mucociliar... | NCT00790166

Studies
Effects of Humidity (During CPAP Treatment) on Mucociliary Clearance in Patients With Obstructive Sleep Apnea

NCT00790166

Sponsor

Fisher and Paykel Healthcare

Status

Terminated

Last Update Posted

Apr 27, 2018Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

CPAP + ThermoSmart™ humidity
CPAP + Conventional humidity
CPAP + No added humidity

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Jun 24, 2009Actual

Completion Date

Jun 24, 2009Actual

First Submitted Date

Nov 11, 2008

First Submission Date that Met QC Criteria

Nov 11, 2008

First Posted Date

Nov 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2018

Last Update Posted Date

Apr 27, 2018Actual

Description Module

Brief Summary

That the level of humidification delivered to patients during CPAP treatment will alter the subjects mucociliary clearance rate and related mucus properties.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPAP + ThermoSmart™ humidity	Device	an absolute humidity (AH) of 28 mg/l +/- 2mg/l	CPAP + ThermoSmart™ humidity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mucociliary clearance.		pre and post cpap treatment with varying levels of humidity

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Moderate to severe obstructive sleep apnea - Apnea Hypopnea Index (AHI) > 15
75% of events during the diagnostic study must be obstructive

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Geraldo Lorenzi, MD	Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital		São Paulo			Brazil

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D045422	Continuous Positive Airway Pressure

Ancestor Terms

ID	Term
D011175	Positive-Pressure Respiration
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided