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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00751335
Recruitment Status : Completed
First Posted : September 11, 2008
Last Update Posted : June 23, 2009
Suburban Lung Associates
Information provided by:
Fisher and Paykel Healthcare

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

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: Heated breathing tube (CPAP with ThermoSmart) Device: Non heated breathing tube (CPAP with conventional humidification) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double-Blind Cross-Over Study Comparing ThermoSmart® to Conventional Heated Humidity in Patients Suing Continuous Positive Airway Pressure
Study Start Date : August 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
Experimental: B
Heated breathing tube (CPAP with Thermosmart)
Device: Heated breathing tube (CPAP with ThermoSmart)
heated humidification with a heated breathing tube.
Other Name: ThermoSmart
Active Comparator: A
Non heated breathing tube (CPAP with conventional humidification)
Device: Non heated breathing tube (CPAP with conventional humidification)
Heated humidification without a heated breathing tube

Primary Outcome Measures :
  1. CPAP compliance [ Time Frame: 1, 4 & 8 weeks ]

Secondary Outcome Measures :
  1. Subjective & objective sleep parameters [ Time Frame: 1, 4 & 8 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00751335

United States, Illinois
Suburban Lung Associates
Chicago, Illinois, United States, 60007
Sponsors and Collaborators
Fisher and Paykel Healthcare
Suburban Lung Associates
Principal Investigator: Clifford A Massie, PhD Suburban Lung Asssociates

Additional Information:
Responsible Party: Emma Duckworth/Clinical Research Manager, Fisher & Paykel Healthcare Identifier: NCT00751335     History of Changes
Other Study ID Numbers: FPHC SLA 2008
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: June 23, 2009
Last Verified: June 2009

Keywords provided by Fisher and Paykel Healthcare:
Obstructive Sleep Apnea
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases