ThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)
Prospective, Randomized, Double-blind Cross-over Study Comparing ThermoSmart® to Conventional Heated Humidity in Patients Suing Continuous Positive Airway Pressure
1 other identifier
interventional
79
1 country
1
Brief Summary
That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2006
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 10, 2008
CompletedFirst Posted
Study publicly available on registry
September 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
September 24, 2020
CompletedSeptember 24, 2020
September 1, 2020
2.2 years
September 10, 2008
September 3, 2020
September 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CPAP Compliance
1, 4 & 8 weeks
Secondary Outcomes (1)
Subjective & Objective Sleep Parameters
1, 4 & 8 weeks
Study Arms (2)
CPAP with ThermoSmart, then CPAP without ThermoSmart
EXPERIMENTALCPAP 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.
CPAP without ThermoSmart, then CPAP with ThermoSmart
EXPERIMENTALCPAP 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- ≥ 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fisher and Paykel Healthcarelead
- Suburban Lung Associatescollaborator
Study Sites (1)
Suburban Lung Associates
Chicago, Illinois, 60007, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research Scientist
- Organization
- Fisher and Paykel Healthcare
Study Officials
- PRINCIPAL INVESTIGATOR
Clifford A Massie, PhD
Suburban Lung Asssociates
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2008
First Posted
September 11, 2008
Study Start
August 1, 2006
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
September 24, 2020
Results First Posted
September 24, 2020
Record last verified: 2020-09