Sleep Apnea, ObstructiveNCT00751335
ThermoSmart® Versus Conventional Humidification in Continuous Positive Airway Pressure (CPAP)
A study testing CPAP with ThermoSmart, then CPAP without ThermoSmart and CPAP without ThermoSmart, then CPAP with ThermoSmart in people with Sleep Apnea, Obstructive, run by Fisher and Paykel Healthcare at 1 site in United States.
Trial summary
That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification. 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?
- CPAP with ThermoSmart, then CPAP without ThermoSmart and CPAP without ThermoSmart, then CPAP with ThermoSmart
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Oct 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
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Double-blind Cross-over Study Comparing ThermoSmart® to Conventional Heated Humidity in Patients Suing Continuous Positive Airway Pressure
That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- CPAP with ThermoSmart, then CPAP without ThermoSmart, CPAP without ThermoSmart, then CPAP with ThermoSmart
- 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.
CPAP with ThermoSmart, then CPAP without ThermoSmartDevice
Also called ThermoSmart
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 without ThermoSmart, then CPAP with ThermoSmartDevice
Also called ThermoSmart
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.
| Study group | Role | What they receive |
|---|---|---|
| CPAP with ThermoSmart, then CPAP without ThermoSmart | Experimental | 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. Receives: Device: CPAP with ThermoSmart, then CPAP without ThermoSmart |
| CPAP without ThermoSmart, then CPAP with ThermoSmart | Experimental | 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. Receives: Device: CPAP without ThermoSmart, then CPAP with ThermoSmart |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP Compliance
Measured: 1, 4 & 8 weeks
Secondary outcomes (1)
Subjective & Objective Sleep Parameters
Measured: 1, 4 & 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startAug 2006
- Primary completionOct 2008
- Study completionOct 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Suburban Lung Associates
- Responsible party
- Sponsor
- Investigators
- Clifford A Massie, PhD, Principal investigator, Suburban Lung Asssociates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751335
- Sponsor's protocol ID
- FPHC SLA 2008
- Status last verified
- Sep 2020
- First submitted
- 10 Sep 2008
- Last updated
- 24 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind Cross-over Study Comparing ThermoSmart® to Conventional Heated Humidity in Patients Suing Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT00751335
- Acronym / sponsor ID
- FPHC SLA 2008
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive Sleep Apnea, Humidification, Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Suburban Lung Associates
- Study start
- Aug 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 11 Sep 2008 (estimated)
- Results
- Posted 24 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
That ThermoSMart humidification will result in greater compliance (mask on time, objective and subjective sleep quality than conventional humidification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP with ThermoSmart, then CPAP without ThermoSmart | Experimental | Device: CPAP with ThermoSmart, then CPAP without ThermoSmartCPAP 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 | Experimental | Device: CPAP without ThermoSmart, then CPAP with ThermoSmartCPAP 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| CPAP with ThermoSmart, then CPAP without ThermoSmartAlso: ThermoSmartCPAP 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. | Device | CPAP with ThermoSmart, then CPAP without ThermoSmart |
| CPAP without ThermoSmart, then CPAP with ThermoSmartAlso: ThermoSmartCPAP 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. | Device | CPAP without ThermoSmart, then CPAP with ThermoSmart |
Primary outcome
CPAP Compliance
Time frame: 1, 4 & 8 weeks
1 secondary outcome
Subjective & Objective Sleep Parameters
Time frame: 1, 4 & 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- 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.
Clifford A Massie, PhD principal investigator
Suburban Lung Asssociates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP with ThermoSmart, then CPAP without ThermoSmart and CPAP without ThermoSmart, then CPAP with ThermoSmart in people with Sleep Apnea, Obstructive, run by Fisher and Paykel Healthcare at 1 site 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 4 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 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 24 Sep 2020). 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?
CPAP Compliance (time frame: 1, 4 & 8 weeks). 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 24 Sep 2020.