- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00681083
Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
May 22, 2019 updated by: Fisher and Paykel Healthcare
Titrations Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
Patients who have Obstructive Sleep Apnea (OSA) may have different Continuous Positive Airway Pressure (CPAP)when titrated with different levels of humidification.
It is hypothesised that patients with ThermoSmart® technology (heated breathing tube technology) will have lower titrated pressures than those who are titrated using conventional humidification (non heated breathing tube).
Study Overview
Status
Completed
Conditions
Detailed Description
Debate is present concerning the optimal level of humidification for obstructive sleep apnea (OSA) patients who need continuous positive airway pressure (CPAP) therapy.
Recent evidence has shown that using a heated breathing tube to increase the amount of humidification that can be delivered has decreased patient side effects, increased subjective sleep quality and decreased subjective symptom scores.
Anecdotal evidence exists, in the form of clinical observation, when ThermoSmart® technology is utilized during CPAP titration, patients laboratory titrated pressure may in fact prove to be lower.
The possibility exists, on a titration night, patients potentially may experience an adverse response to the positive airway pressure which manifests as increased airway resistance and inflammation necessitating higher CPAP pressures to overcome upper airway resistance and flow limitation.
Therefore, we hypothesize the delivery of higher levels of humidity might reduce the nasal airway resistance during the titration night, reducing the overall positive airway pressure requirements.
The goal is to investigate this phenomenon to find if a reduction in pressure is necessary and if so to what degree.
Patients who are titrated on Continuous Positive Airway Pressure devices with ThermoSmart® technology will have lower titrated pressures than those who are titrated using conventional humidification.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Oklahoma
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Tulsa, Oklahoma, United States, 74135
- Sleep Center of Tulsa - Midtown
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Tulsa, Oklahoma, United States, 74137
- Sleep Center of Tulsa - South
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and Female patients over the age of 18
- Apnea Hypopnea Index (AHI) ≥15
- Patients must have at least 5 hours sleep time on each titration night
- Stable medications for 2 weeks prior to entry to the study and for study inclusion duration including sleep aids
Exclusion Criteria:
- Receiving or requiring bi-level ventilation
- Use of a full face interface or chin strap
- Previous UPPP surgery or palatal reconstruction
- Recent angina symptoms within 2 weeks of entry
- CHF with EF < 40%
- Obesity Hypoventilation Syndrome
- Cheyne Stokes respiration
- > 50% Central apneas recorded on diagnostic polysomnogram
- Supplemental oxygen use
- Use of narcotic pain medication
- Hypoxemia as determined by room air pulse oxymetry of less than 89% on room air at rest awake
- Inability to tolerate positive pressure therapy
- Split Night Evaluations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Heated breathing tube
|
CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube
Other Names:
|
Active Comparator: 2
Non heated breathing tube
|
CPAP with conventional humidification - heated passover humidifier, no heated breathing tube
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Titration Pressures After Treatment Nights
Time Frame: End of titration night
|
Each night, the participant underwent a CPAP titration to determine their therapeutic pressure.
During a titration, a sleep technician manually adjusts the participants pressure to determine which pressure is best for that individual in reducing their Apnea Hypopnea Index (AHI) which is the measure of Obstructive Sleep Apnea (OSA) severity.
Titration pressures for each group were compared to see if there was any impact of having a heated breathing tube versus a non heated breathing tube on titration pressure.
|
End of titration night
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship Between the Intervention (Heated Breathing Tube vs Non Heated Breathing Tube) and Total Sleep Time
Time Frame: End of titration night
|
A correlation table was computed to explore the relationship between the intervention (heated breathing tube vs no heated breathing tube) and total sleep time.
This relationship was calculated for each arm and reported by a Correlation Coefficient (r score).
The r score represents the strength and direction of a relationship between two variables.
The value of r is always between -1 and +1.
Therefore, an r score of -1 indicates a perfect negative relationship between the intervention and total sleep time.
An r score of -.50 indicates a moderate negative relationship between the intervention and total sleep time.
An r score of 0 indicates no relationship between the intervention and total sleep time.
An r score of +.50 indicates a moderate positive relationship between the intervention and total sleep time.
An r score of +1 indicates a perfect positive relationship between the intervention and total sleep time.
|
End of titration night
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kevin L Lewis, M.D., Sleep Disorder Centers Institute for Clinical Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
May 19, 2008
First Submitted That Met QC Criteria
May 20, 2008
First Posted (Estimate)
May 21, 2008
Study Record Updates
Last Update Posted (Actual)
June 12, 2019
Last Update Submitted That Met QC Criteria
May 22, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPHC SDC 2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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