Obstructive Sleep Apnea SyndromesPREDIVARIUSNCT02749812
Interest of Treatment of Obstructive Sleep Apnea Syndrome by Constant CPAP and Auto CPAP
A study testing Constant Continuous Positive Airway Pressure and Automatic continuous Positive Airway Pressure in people with Obstructive Sleep Apnea Syndromes, run by Poitiers University Hospital.
Trial summary
The investigators propose a multicentric controlled randomized trial whose goal is to evaluate the possibility of a prediction of the efficiency of APAP (automatic continuous positive airway pressure) and constant CPAP (constant positive airway pressure) in 800 severe obstructive sleep apnea syndrome (OSAS) patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndromes
- What is being tested?
- Constant Continuous Positive Airway Pressure and Automatic continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult patients > 18 with severe OSAS (AHI > 30/h)
- Patients naive of any previous OSAS treatment
- Written informed consent
Who cannot join
- Patients
- with more than 20% of central events at the initial polygraphic recording
- previously treated by CPAP
- previously treated for OSAS by any surgical procedure involving upper airways
- < 18
- with cardiac insufficiency
Show all 10Show fewer
- with Chronic Obstructive Pulmonary Disease or obesity-hypoventilation syndrome
- without health insurance
- pregnant or lactating
- presumed uncooperativeness or legal incapacity
About this study
Official title: Beneficial Effects of Obstructive Sleep Apnea Syndrome (OSAS) Treatment by Automatic Continuous Positive Airway Pressure (APAP) vs Constant Continuous Positive Airway Pressure (Constant CPAP) According to the Level of the Efficient Pressure and Its Variability. A Multicentric Randomized Trial
The investigators propose a multicentric controlled randomized trial whose goal is to evaluate the possibility of a prediction of the efficiency of APAP (automatic continuous positive airway pressure) and constant CPAP (constant positive airway pressure) in 800 severe obstructive sleep apnea syndrome (OSAS) patients according to their profile of pressure variability.
Read the detailed description
Multicenter open randomized clinical trial involving 800 patients with severe OSAS. After inclusion in the study, the patients will be proposed to initiate CPAP at home (ResMed S9 or PHILIPS PR1) using systematically an APAP mode between wide range of pressure variations (4 to 20 cm H2O) during the first 7day-period of time. After this first period of treatment, an analysis of the report will be released from the APAP in order evaluate the residual AHI, the duration of CPAP use and the amount of leaks in order to confirm CPAP efficiency and observance. Pressure parameters (efficient pressure and variability) will be collected. After randomization according to the further mode of ventilation to use (APAP vs constant CPAP), the patients will be treated at home for 3 months. In the constant CPAP group, efficient pressure will be determined as the P95 (ResMed) or the P90 (PHILIPS) as recommended by the manufacturers, while in the APAP group, the patients will be treated within the same range of pressure variations than during the first 7 day-period. Clinical and polygraphic evaluation will be done after 3 months of treatment, using the combined criteria previously described. In each group, results will be considered according to the efficient pressure value and its variability that were evaluated at the end of the first 7 day-period of treatment
- Conditions
- Obstructive Sleep Apnea Syndromes
- Being tested
- Constant Continuous Positive Airway Pressure, Automatic continuous Positive Airway Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constant Continuous Positive Airway PressureDevice
Automatic continuous Positive Airway PressureDevice
| Study group | Role | What they receive |
|---|---|---|
| Constant Continuous Positive Airway Pressure | Experimental | Not described Receives: Device: Constant Continuous Positive Airway Pressure |
| automatic Continuous Positive Airway Pressure | Experimental | Not described Receives: Device: Automatic continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
A combined score that takes into account the residual apnea hypopnea index (AHI) under CPAP associated with the value of the Epworth score after 3 months of treatment.
The main objective of this study is to evaluate the ability to predict the mode of CPAP to use (APAP vs constant CPAP) in the treatment of OSAS patients, according to their own level of efficient pressure and its variability obtained on CPAP report after the first 7 days of use in an initial and systematic APAP mode. This prediction will be evaluated by using the association of the residual AHI value under CPAP and the Epworth score value obtained after 3 months of treatment, in each group of CPAP mode (constant vs APAP) used during the study. This combined criteria will be used according an ordinal scale with six levels of severity. It will be evaluated in each group (constant CPAP vs APAP) according to the level of P90 or P95 and the degree of pressure variability obtained during the first 7 day-period of use.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startJan 2013
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02749812
- Sponsor's protocol ID
- PREDIVARIUS
- Acronym
- PREDIVARIUS
- Status last verified
- Apr 2016
- First submitted
- 11 Apr 2016
- Last updated
- 25 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Obstructive Sleep Apnea Syndrome (OSAS) Treatment by Automatic Continuous Positive Airway Pressure (APAP) vs Constant Continuous Positive Airway Pressure (Constant CPAP) According to the Level of the Efficient Pressure and Its Variability. A Multicentric Randomized Trial
- ClinicalTrials.gov ID
- NCT02749812
- Acronym / sponsor ID
- PREDIVARIUS / PREDIVARIUS
- Conditions
- Obstructive Sleep Apnea Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a multicentric controlled randomized trial whose goal is to evaluate the possibility of a prediction of the efficiency of APAP (automatic continuous positive airway pressure) and constant CPAP (constant positive airway pressure) in 800 severe obstructive sleep apnea syndrome (OSAS) patients according to their profile of pressure variability.
Detailed description
Multicenter open randomized clinical trial involving 800 patients with severe OSAS. After inclusion in the study, the patients will be proposed to initiate CPAP at home (ResMed S9 or PHILIPS PR1) using systematically an APAP mode between wide range of pressure variations (4 to 20 cm H2O) during the first 7day-period of time. After this first period of treatment, an analysis of the report will be released from the APAP in order evaluate the residual AHI, the duration of CPAP use and the amount of leaks in order to confirm CPAP efficiency and observance. Pressure parameters (efficient pressure and variability) will be collected. After randomization according to the further mode of ventilation to use (APAP vs constant CPAP), the patients will be treated at home for 3 months. In the constant CPAP group, efficient pressure will be determined as the P95 (ResMed) or the P90 (PHILIPS) as recommended by the manufacturers, while in the APAP group, the patients will be treated within the same range of pressure variations than during the first 7 day-period. Clinical and polygraphic evaluation will be done after 3 months of treatment, using the combined criteria previously described. In each group, results will be considered according to the efficient pressure value and its variability that were evaluated at the end of the first 7 day-period of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constant Continuous Positive Airway Pressure | Experimental | Device: Constant Continuous Positive Airway Pressure |
| automatic Continuous Positive Airway Pressure | Experimental | Device: Automatic continuous Positive Airway Pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients > 18 with severe OSAS (AHI > 30/h)
- Patients naive of any previous OSAS treatment
- Written informed consent
Key exclusion criteria (10 listed)
- Patients
- with more than 20% of central events at the initial polygraphic recording
- previously treated by CPAP
- previously treated for OSAS by any surgical procedure involving upper airways
- < 18
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 |
|---|---|---|
| Constant Continuous Positive Airway Pressure | Device | Constant Continuous Positive Airway Pressure |
| Automatic continuous Positive Airway Pressure | Device | automatic Continuous Positive Airway Pressure |
Primary outcome
A combined score that takes into account the residual apnea hypopnea index (AHI) under CPAP associated with the value of the Epworth score after 3 months of treatment.
Time frame: 3 months
The main objective of this study is to evaluate the ability to predict the mode of CPAP to use (APAP vs constant CPAP) in the treatment of OSAS patients, according to their own level of efficient pressure and its variability obtained on CPAP report after the first 7 days of use in an initial and systematic APAP mode. This prediction will be evaluated by using the association of the residual AHI value under CPAP and the Epworth score value obtained after 3 months of treatment, in each group of CPAP mode (constant vs APAP) used during the study. This combined criteria will be used according an ordinal scale with six levels of severity. It will be evaluated in each group (constant CPAP vs APAP) according to the level of P90 or P95 and the degree of pressure variability obtained during the first 7 day-period of use.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Constant Continuous Positive Airway Pressure and Automatic continuous Positive Airway Pressure in people with Obstructive Sleep Apnea Syndromes, run by Poitiers University Hospital.
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 3 inclusion and 10 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 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
A combined score that takes into account the residual apnea hypopnea index (AHI) under CPAP associated with the value of the Epworth score after 3 months of treatment. (time frame: 3 months). 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 25 Apr 2016.