Sleep Apnea, ObstructiveNCT00681083
Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
A study testing Heated breathing tube (CPAP with ThermoSmart) and Non heated breathing tube (CPAP with conventional humidification) in people with Sleep Apnea, Obstructive, run by Fisher and Paykel Healthcare at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Heated breathing tube (CPAP with ThermoSmart) and Non heated breathing tube (CPAP with conventional humidification)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Jul 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sleep Center of Tulsa - Midtown
Tulsa, Oklahoma, 74135
Sleep Center of Tulsa - South
Tulsa, Oklahoma, 74137
About this study
Official title: 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).
Read the 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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Heated breathing tube (CPAP with ThermoSmart), Non heated breathing tube (CPAP with conventional humidification)
- Keywords
- Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated breathing tube (CPAP with ThermoSmart)Device
Also called ThermoSmart
CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube
Non heated breathing tube (CPAP with conventional humidification)Device
Also called Conventional humidification
CPAP with conventional humidification - heated passover humidifier, no heated breathing tube
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Heated breathing tube Receives: Device: Heated breathing tube (CPAP with ThermoSmart) |
| 2 | Active comparator | Non heated breathing tube Receives: Device: Non heated breathing tube (CPAP with conventional humidification) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of titration night
Secondary outcomes (1)
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.
Measured: End of titration night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startApr 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sleep Disorder Centers Institute for Clinical Research
- Responsible party
- Sponsor
- Investigators
- Kevin L Lewis, M.D., Principal investigator, Sleep Disorder Centers Institute for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681083
- Sponsor's protocol ID
- FPHC SDC 2008
- Status last verified
- May 2019
- First submitted
- 19 May 2008
- Last updated
- 12 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titrations Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
- ClinicalTrials.gov ID
- NCT00681083
- Acronym / sponsor ID
- FPHC SDC 2008
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Sleep Disorder Centers Institute for Clinical Research
- Study start
- Apr 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Posted 12 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Heated breathing tube (CPAP with ThermoSmart)Heated breathing tube |
| 2 | Active comparator | Device: Non heated breathing tube (CPAP with conventional humidification)Non heated breathing tube |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heated breathing tube (CPAP with ThermoSmart)Also: ThermoSmartCPAP with ThermoSmart - heated passover humidifier, with heated breathing tube | Device | 1 |
| Non heated breathing tube (CPAP with conventional humidification)Also: Conventional humidificationCPAP with conventional humidification - heated passover humidifier, no heated breathing tube | Device | 2 |
Primary outcome
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.
1 secondary outcome
Relationship Between the Intervention (Heated Breathing Tube vs Non Heated Breathing Tube) and Total Sleep Time
Time frame: End of titration night
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Fisher \& Paykel HealthcareLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin L Lewis, M.D. principal investigator
Sleep Disorder Centers Institute for Clinical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heated breathing tube (CPAP with ThermoSmart) and Non heated breathing tube (CPAP with conventional humidification) in people with Sleep Apnea, Obstructive, run by Fisher and Paykel Healthcare at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Titration Pressures After Treatment Nights (time frame: End of titration night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.