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Completed

NCT Number: NCT00751335

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

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

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Suburban Lung Associates

Chicago, Illinois, 60007, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years of age
  • 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.
  • AHI ≥ 15 OR AHI ≥ 5 + ESS ≥ 10 OR ESS ≥ 10 + a medical co-morbidity
  • Patient willing to give informed consent and follow study protocol.

Exclusion criteria

  • Wake resting SpO2 < 90%
  • Patient requires BiLevel PAP or supplemental oxygen
  • The patient is medically unstable (e.g. respiratory or cardiac failure)
  • Patient unwilling to give informed consent or follow study protocol.

Treatment and study plan

CPAP with ThermoSmart, then CPAP without ThermoSmart

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.

Other names: ThermoSmart

CPAP without ThermoSmart, then CPAP with ThermoSmart

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.

Other names: ThermoSmart

Primary outcomes

  1. CPAP Compliance

    Time frame: 1, 4 & 8 weeks

Secondary outcomes

  1. Subjective & Objective Sleep Parameters

    Time frame: 1, 4 & 8 weeks

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Collaborators

  • Suburban Lung Associates

Registry information

Official study title

Prospective, Randomized, Double-blind Cross-over Study Comparing ThermoSmart® to Conventional Heated Humidity in Patients Suing Continuous Positive Airway Pressure

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 11, 2008
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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