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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00751335
First Posted: September 11, 2008
Last Update Posted: June 23, 2009
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.
Collaborator:
Suburban Lung Associates
Information provided by:
Fisher and Paykel Healthcare
  Purpose
That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.

Condition Intervention
Sleep Apnea, Obstructive Device: Heated breathing tube (CPAP with ThermoSmart) Device: Non heated breathing tube (CPAP with conventional humidification)

Study Type: Interventional
Study Design: 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

Further study details as provided by Fisher and Paykel Healthcare:

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

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

Enrollment: 79
Study Start Date: August 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00751335


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

Additional Information:
Responsible Party: Emma Duckworth/Clinical Research Manager, Fisher & Paykel Healthcare
ClinicalTrials.gov Identifier: NCT00751335     History of Changes
Other Study ID Numbers: FPHC SLA 2008
First Submitted: September 10, 2008
First Posted: September 11, 2008
Last Update Posted: June 23, 2009
Last Verified: June 2009

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

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