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

This study has been completed.
Sponsor:
Collaborator:
Suburban Lung Associates
Information provided by:
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT00751335
First received: September 10, 2008
Last updated: June 22, 2009
Last verified: June 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Fisher and Paykel Healthcare:

Primary Outcome Measures:
  • CPAP compliance [ Time Frame: 1, 4 & 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective & objective sleep parameters [ Time Frame: 1, 4 & 8 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Suburban Lung Associates  This link exits the ClinicalTrials.gov site
Fisher & Paykel Healthcare  This link exits the ClinicalTrials.gov site
Chicago Sleep Group  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Emma Duckworth/Clinical Research Manager, Fisher & Paykel Healthcare
ClinicalTrials.gov Identifier: NCT00751335     History of Changes
Other Study ID Numbers: FPHC SLA 2008
Study First Received: September 10, 2008
Last Updated: June 22, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 21, 2013