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

NCT ID: NCT00790166

Last Updated: 2018-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-06-24

Brief Summary

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

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CPAP + ThermoSmart™ humidity

Group Type ACTIVE_COMPARATOR

CPAP + ThermoSmart™ humidity

Intervention Type DEVICE

an absolute humidity (AH) of 28 mg/l +/- 2mg/l

CPAP + Conventional humidity

Group Type ACTIVE_COMPARATOR

CPAP + Conventional humidity

Intervention Type DEVICE

an absolute humidity (AH) of 18 mg/l +/- 2 mg/l

CPAP + No added humidity

Group Type ACTIVE_COMPARATOR

CPAP + No added humidity

Intervention Type DEVICE

ambient humidity

Interventions

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CPAP + ThermoSmart™ humidity

an absolute humidity (AH) of 28 mg/l +/- 2mg/l

Intervention Type DEVICE

CPAP + Conventional humidity

an absolute humidity (AH) of 18 mg/l +/- 2 mg/l

Intervention Type DEVICE

CPAP + No added humidity

ambient humidity

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geraldo Lorenzi, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital

Locations

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Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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OSA CPAP,ThemoSmartMCC, Brasil

Identifier Type: -

Identifier Source: org_study_id

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