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

This study is currently recruiting participants.

Verified by Fisher and Paykel Healthcare, September 2008

First Received: September 10, 2008 No Changes Posted

Sponsors and Collaborators:	Fisher and Paykel Healthcare Suburban Lung Associates
Information provided by:	Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:	NCT00751335

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)

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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

Estimated Enrollment:	80
Study Start Date:	August 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Experimental Heated breathing tube (CPAP with Thermosmart)	Device: Heated breathing tube (CPAP with ThermoSmart) heated humidification with a heated breathing tube.
A: Active Comparator 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:

≥ 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751335

Contacts

Contact: Judy Goodman, CCRC

847.981.3660

sla@sublung.com

Locations

United States, Illinois
Suburban Lung Associates	Recruiting
Chicago, Illinois, United States, 60007
Principal Investigator: Clifford A Massie, PhD

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

Keywords provided by Fisher and Paykel Healthcare:

Obstructive Sleep Apnea
Humidification
Continuous Positive Airway Pressure

Study placed in the following topic categories:

Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders

Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Nervous System Diseases
Respiration Disorders

Sleep Apnea, Obstructive
Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on May 07, 2009