Overlap SyndromeNCT03766542
Continuous Positive Pressure Versus Bi-level in Overlap Syndrome
A study testing Bi-level positive airway pressure with ventilatory support and continuous positive airway pressure without ventilatory support in people with Overlap Syndrome and Nocturnal Hypoventilation, run by Hospital Sao Joao.
Trial summary
Continuous positive airway pressure (CPAP) became the established treatment for overlap syndrome (OS). It has been showed that the survival benefits of CPAP favored hypercapnic patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Overlap Syndrome, Nocturnal Hypoventilation
- What is being tested?
- Bi-level positive airway pressure with ventilatory support and continuous positive airway pressure without ventilatory support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Sep 2020
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD (FEV1/FVC < 70 (post-BD) and history of smoking - 10 PPY)
- FEV1< 80% and COPD symptoms
- AHI ≥ 15 events/hour
Who cannot join
- Persistent hypercapnic respiratory failure with acidosis (defined as pH <7.30 after bronchodilators)
- Hypoxia requiring long term oxygen therapy
- BMI > 35 kg/m2
- Previously-initiated long term non-invasive positive pressure ventilation
- Other lung disease resulting in respiratory symptoms
- Age <40 years
Show all 12Show fewer
- Pregnancy
- Malignant comorbidities
- Patients undergoing renal replacement therapy
- Restrictive lung disease causing hypercapnia
- Severe heart failure, unstable angina and severe arrhythmias
- Inability to comply with the protocol
About this study
Official title: Optimal Positive Airway Pressure in Overlap Syndrome: a Randomized Controlled Trial
Continuous positive airway pressure (CPAP) became the established treatment for overlap syndrome (OS). It has been showed that the survival benefits of CPAP favored hypercapnic patients. When considering hypercapnic stable COPD patients, survival benefits occurred when the use of bi- level ventilation therapy was targeted to significantly reduce hypercapnia.
This highlights the relevance of hypercapnia and hypoventilation correction. Thus, the purpose of this study is to compare the use of CPAP to Bi-level ventilation in hypercapnic OS patients, since the later may correct not only the airway patency but also increase the magnitude of each breath.
Read the detailed description
Obstructive sleep apnea syndrome (OSAS) and chronic obstructive pulmonary disease (COPD) represent two of the most prevalent respiratory disorders in clinical practice and their coexistence is often described has "overlap syndrome" (OS) In patients with COPD, the coexistence of OSA is associated with an increased risk of death from any cause, and hospitalization because of COPD exacerbation. Treatment with continuous positive airway pressure (CPAP) has been showed to be effective and associated with improved survival and decreased hospitalizations. When CPAP became established treatment for overlap syndrome, a multivariate analysis revealed that the hours of CPAP use were an independent predictor of mortality. Furthermore, it has been showed that the survival benefit of CPAP favors hypercapnic patients with overlap syndrome.
Regarding hypercapnic stable COPD patients, the best results with long-term non-invasive positive pressure ventilation have been noted in studies using more intensive strategies of ventilation, with higher inspiratory pressures and higher backup rates that improved or even normalized daytime hypercapnia. In fact, survival benefits occurred when ventilation was targeted to significantly reduce hypercapnia.
As for typical COPD, overlap syndrome patients might also benefit from optimal daytime hypercapnia correction, which could be better achieved using bi-level ventilation instead of CPAP, since it could not only maintain airway patency but also improve alveolar ventilation.
This study aims to compare CPAP therapy to bi-level ventilatory support in overlap syndrome patients, not only for the efficacy to achieve hypercapnia reduction, but also regarding acute disease exacerbations, symptoms and treatment compliance. Therefore, the authors designed a randomized controlled trial with recruitment and power calculations based on the applicant's own data.
After the diagnosis, patients will be randomized either for CPAP or BPAP treatment.
If CPAP is to be initiated, optimal pressure to maintain upper airway patency will be determined. If there are continued obstructive respiratory events at 15 cm H2O of CPAP, patients will cross-over to the BPAP study arm.
Regarding BPAP titration, patients will be treated with ventilators set in pressure support spontaneous/timed mode, both inspiratory and expiratory positive airway pressures (IPAP and EPAP) will be manually titrated. EPAP will ensure optimal pressure for maintaining upper airway patency and IPAP will be defined according to patient tolerance and pressure support necessary to achieve normal PaCO2 values or to reduce baseline PaCO2 by 20% or more; Follow-up will be performed at 1, 6 and 12 months. Follow-up will include clinical evaluation with physical examination and questionnaires (COPD Assessment test, Epworth Sleepiness Scale and MRC dyspnea score), blood gas analysis, treatment adherence, AHI, nocturnal pulse oximetry and exacerbations.
12-month follow-up will also include lung function test, 6-min walking test and nocturnal capnography.
- Conditions
- Overlap Syndrome, Nocturnal Hypoventilation
- Being tested
- Bi-level positive airway pressure with ventilatory support, continuous positive airway pressure without ventilatory support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-level positive airway pressure with ventilatory supportDevice
Positive airway pressure will be applied in the experimental group through a oronasal interface, in ventilatory support mode (Bi-level) with a fixed backup rate.
continuous positive airway pressure without ventilatory supportDevice
Continuous positive airway pressure (CPAP) will be applied in the active comparator group through a oronasal interface.
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Active comparator | Oronasal CPAP therapy applied as per current international guidelines Receives: Device: continuous positive airway pressure without ventilatory support |
| Bi-level | Experimental | Oronasal Bi-level therapy + supplemental oxygen (if necessary) applied as per current international guidelines Receives: Device: Bi-level positive airway pressure with ventilatory support |
What is being measured
The primary outcome is the main question the study is designed to answer.
diurnal hypercapnia (pCO2 <= 45 mmH2O )
(PaCO2 <= 45 mmH2O )
Measured: 1 year
nocturnal oxygen desaturation correction
Mean nocturnal SpO2 >=90%, with <10% of the total recording time <90% after correction of leaks)
Measured: 1 year
Secondary outcomes (12)
Changes in FEV1
Forced Expiratory Volume (FEV1) in first second (% of predicted) from pre-intervention to follow up
Measured: 1 year
Changes in FVC
Forced vital capacity (FVC) (% of predicted) from pre-intervention to follow up
Measured: 1 year
Changes in RV
Residual volume (RV) (% of predicted) from pre-intervention to follow up
Measured: 1 year
exercise tolerance
Change in the 6 minute walking test from pre-intervention to follow up
Measured: 1 year
Sleepiness evaluation
Epworth sleepiness scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Comparation of patient score from pre-intervention to follow up
Measured: 1 year
acute respiratory exacerbations
Frequency of acute exacerbations of COPD requiring addition of antibiotics and or steroids and or hospital admission
Measured: 1 year
Compliance to PAP
median hours of compliance per night
Measured: 1 year
PAP usage
percentage of days of use per month
Measured: 1 year
Dyspnoea evaluation
The mMRC Dyspnea Scale quantifies disability attributable to breathlessness and is useful for baseline dyspnea characterization in patients with respiratory diseases. The score can range from 0 to 4. The higher the mMRC score the higher the dyspnea.
Comparation of patient score from pre-intervention to follow up
Measured: 1 year
Symptoms of COPD
COPD Assessment test
Measured: 1 year
Apneia/Hiponeia Index
Number of Residual AHI/per hour
Measured: 1 year
nocturnal hypoventilation
∆PtcCO2<10mmHg during night from pre-intervention to follow up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overlap SyndromeStudies of the same condition, open and under way.
- 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
- Model description
- Prospective randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Joao
- Sponsor type
- University, hospital or other
- Collaborators
- Marta Drummond MD PhD, Joao Carlos Winck MD PhD, Mafalda van Zeller MD Phstud
- Responsible party
- Principal investigator, Miguel R. Goncalves, Hospital Sao Joao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766542
- Sponsor's protocol ID
- OSPAP study
- Status last verified
- Dec 2018
- First submitted
- 8 Feb 2017
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Positive Airway Pressure in Overlap Syndrome: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03766542
- Acronym / sponsor ID
- OSPAP study
- Conditions
- Overlap Syndrome, Nocturnal Hypoventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospital Sao JoaoUniversity, hospital or other
- Collaborators
- Marta Drummond MD PhD, Joao Carlos Winck MD PhD, Mafalda van Zeller MD Phstud
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 6 Dec 2018 (actual)
- 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.
Continuous positive airway pressure (CPAP) became the established treatment for overlap syndrome (OS). It has been showed that the survival benefits of CPAP favored hypercapnic patients. When considering hypercapnic stable COPD patients, survival benefits occurred when the use of bi- level ventilation therapy was targeted to significantly reduce hypercapnia.
This highlights the relevance of hypercapnia and hypoventilation correction. Thus, the purpose of this study is to compare the use of CPAP to Bi-level ventilation in hypercapnic OS patients, since the later may correct not only the airway patency but also increase the magnitude of each breath.
Detailed description
Obstructive sleep apnea syndrome (OSAS) and chronic obstructive pulmonary disease (COPD) represent two of the most prevalent respiratory disorders in clinical practice and their coexistence is often described has "overlap syndrome" (OS) In patients with COPD, the coexistence of OSA is associated with an increased risk of death from any cause, and hospitalization because of COPD exacerbation. Treatment with continuous positive airway pressure (CPAP) has been showed to be effective and associated with improved survival and decreased hospitalizations. When CPAP became established treatment for overlap syndrome, a multivariate analysis revealed that the hours of CPAP use were an independent predictor of mortality. Furthermore, it has been showed that the survival benefit of CPAP favors hypercapnic patients with overlap syndrome.
Regarding hypercapnic stable COPD patients, the best results with long-term non-invasive positive pressure ventilation have been noted in studies using more intensive strategies of ventilation, with higher inspiratory pressures and higher backup rates that improved or even normalized daytime hypercapnia. In fact, survival benefits occurred when ventilation was targeted to significantly reduce hypercapnia.
As for typical COPD, overlap syndrome patients might also benefit from optimal daytime hypercapnia correction, which could be better achieved using bi-level ventilation instead of CPAP, since it could not only maintain airway patency but also improve alveolar ventilation.
This study aims to compare CPAP therapy to bi-level ventilatory support in overlap syndrome patients, not only for the efficacy to achieve hypercapnia reduction, but also regarding acute disease exacerbations, symptoms and treatment compliance. Therefore, the authors designed a randomized controlled trial with recruitment and power calculations based on the applicant's own data.
After the diagnosis, patients will be randomized either for CPAP or BPAP treatment.
If CPAP is to be initiated, optimal pressure to maintain upper airway patency will be determined. If there are continued obstructive respiratory events at 15 cm H2O of CPAP, patients will cross-over to the BPAP study arm.
Regarding BPAP titration, patients will be treated with ventilators set in pressure support spontaneous/timed mode, both inspiratory and expiratory positive airway pressures (IPAP and EPAP) will be manually titrated. EPAP will ensure optimal pressure for maintaining upper airway patency and IPAP will be defined according to patient tolerance and pressure support necessary to achieve normal PaCO2 values or to reduce baseline PaCO2 by 20% or more; Follow-up will be performed at 1, 6 and 12 months. Follow-up will include clinical evaluation with physical examination and questionnaires (COPD Assessment test, Epworth Sleepiness Scale and MRC dyspnea score), blood gas analysis, treatment adherence, AHI, nocturnal pulse oximetry and exacerbations.
12-month follow-up will also include lung function test, 6-min walking test and nocturnal capnography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| CPAP | Active comparator | Device: continuous positive airway pressure without ventilatory supportOronasal CPAP therapy applied as per current international guidelines |
| Bi-level | Experimental | Device: Bi-level positive airway pressure with ventilatory supportOronasal Bi-level therapy + supplemental oxygen (if necessary) applied as per current international guidelines |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD (FEV1/FVC < 70 (post-BD) and history of smoking - 10 PPY)
- FEV1< 80% and COPD symptoms
- AHI ≥ 15 events/hour
Key exclusion criteria (12 listed)
- Persistent hypercapnic respiratory failure with acidosis (defined as pH <7.30 after bronchodilators)
- Hypoxia requiring long term oxygen therapy
- BMI > 35 kg/m2
- Previously-initiated long term non-invasive positive pressure ventilation
- Other lung disease resulting in respiratory symptoms
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 |
|---|---|---|
| Bi-level positive airway pressure with ventilatory supportPositive airway pressure will be applied in the experimental group through a oronasal interface, in ventilatory support mode (Bi-level) with a fixed backup rate. | Device | Bi-level |
| continuous positive airway pressure without ventilatory supportContinuous positive airway pressure (CPAP) will be applied in the active comparator group through a oronasal interface. | Device | CPAP |
Primary outcome
diurnal hypercapnia (pCO2 <= 45 mmH2O )
Time frame: 1 year
(PaCO2 <= 45 mmH2O )
nocturnal oxygen desaturation correction
Time frame: 1 year
Mean nocturnal SpO2 >=90%, with <10% of the total recording time <90% after correction of leaks)
12 secondary outcomes
Changes in FEV1
Time frame: 1 year
Changes in FVC
Time frame: 1 year
Changes in RV
Time frame: 1 year
exercise tolerance
Time frame: 1 year
Sleepiness evaluation
Time frame: 1 year
acute respiratory exacerbations
Time frame: 1 year
Compliance to PAP
Time frame: 1 year
PAP usage
Time frame: 1 year
Dyspnoea evaluation
Time frame: 1 year
Symptoms of COPD
Time frame: 1 year
Apneia/Hiponeia Index
Time frame: 1 year
nocturnal hypoventilation
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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 Bi-level positive airway pressure with ventilatory support and continuous positive airway pressure without ventilatory support in people with Overlap Syndrome and Nocturnal Hypoventilation, run by Hospital Sao Joao.
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 12 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: status not confirmed, as of the sponsor's last update on 6 Dec 2018. 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?
Results are not available in the source record.
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?
diurnal hypercapnia (pCO2 <= 45 mmH2O ) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 6 Dec 2018.