Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heated breathing tube (CPAP with ThermoSmart)
Non heated breathing tube (CPAP with conventional humidification)
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure
Eligibility Criteria
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
Sites / Locations
- Sleep Center of Tulsa - Midtown
- Sleep Center of Tulsa - South
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Heated breathing tube
Non heated breathing tube
Outcomes
Primary Outcome Measures
Titration Pressures After Treatment Nights
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.
Secondary Outcome Measures
Relationship Between the Intervention (Heated Breathing Tube vs Non Heated Breathing Tube) and Total Sleep Time
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.
Full Information
NCT ID
NCT00681083
First Posted
May 19, 2008
Last Updated
May 22, 2019
Sponsor
Fisher and Paykel Healthcare
Collaborators
Sleep Disorder Centers Institute for Clinical Research
1. Study Identification
Unique Protocol Identification Number
NCT00681083
Brief Title
Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
Official Title
Titrations Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
Collaborators
Sleep Disorder Centers Institute for Clinical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Heated breathing tube
Arm Title
2
Arm Type
Active Comparator
Arm Description
Non heated breathing tube
Intervention Type
Device
Intervention Name(s)
Heated breathing tube (CPAP with ThermoSmart)
Other Intervention Name(s)
ThermoSmart
Intervention Description
CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube
Intervention Type
Device
Intervention Name(s)
Non heated breathing tube (CPAP with conventional humidification)
Other Intervention Name(s)
Conventional humidification
Intervention Description
CPAP with conventional humidification - heated passover humidifier, no heated breathing tube
Primary Outcome Measure Information:
Title
Titration Pressures After Treatment Nights
Description
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.
Time Frame
End of titration night
Secondary Outcome Measure Information:
Title
Relationship Between the Intervention (Heated Breathing Tube vs Non Heated Breathing Tube) and Total Sleep Time
Description
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.
Time Frame
End of titration night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin L Lewis, M.D.
Organizational Affiliation
Sleep Disorder Centers Institute for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Center of Tulsa - Midtown
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Sleep Center of Tulsa - South
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74137
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.fphcare.com
Description
Fisher & Paykel Healthcare
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Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
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