ThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)

NCT ID: NCT00751335

Last Updated: 2020-09-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-10-31

Brief Summary

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That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.

Detailed Description

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Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CPAP with ThermoSmart, then CPAP without ThermoSmart

CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.

CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.

Group Type EXPERIMENTAL

CPAP with ThermoSmart, then CPAP without ThermoSmart

Intervention Type DEVICE

CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.

CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.

CPAP without ThermoSmart, then CPAP with ThermoSmart

CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.

CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.

Group Type EXPERIMENTAL

CPAP without ThermoSmart, then CPAP with ThermoSmart

Intervention Type DEVICE

CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.

CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.

Interventions

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CPAP with ThermoSmart, then CPAP without ThermoSmart

CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.

CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.

Intervention Type DEVICE

CPAP without ThermoSmart, then CPAP with ThermoSmart

CPAP with ThermoSmart is the application of CPAP with heated humidification and a heated breathing tube.

CPAP without ThermSmart is the application of CPAP with heated humidification without a heated breathing tube.

Intervention Type DEVICE

Other Intervention Names

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ThermoSmart ThermoSmart

Eligibility Criteria

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Inclusion Criteria

1. ≥ 18 years of age
2. Previous diagnosis of OSA permitted, but patient must be novel to CPAP and no previous surgical intervention for OSA or treatment with an oral appliance.
3. AHI ≥ 15 OR AHI ≥ 5 + ESS ≥ 10 OR ESS ≥ 10 + a medical co-morbidity
4. Patient willing to give informed consent and follow study protocol.

Exclusion Criteria

1. Wake resting SpO2 \< 90%
2. Patient requires BiLevel PAP or supplemental oxygen
3. The patient is medically unstable (e.g. respiratory or cardiac failure)
4. Patient unwilling to give informed consent or follow study protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suburban Lung Associates

OTHER

Sponsor Role collaborator

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clifford A Massie, PhD

Role: PRINCIPAL_INVESTIGATOR

Suburban Lung Asssociates

Locations

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Suburban Lung Associates

Chicago, Illinois, United States

Site Status

Countries

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United States

Related Links

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http://fphcare.com

Fisher \& Paykel Healthcare

Other Identifiers

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FPHC SLA 2008

Identifier Type: -

Identifier Source: org_study_id

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