Obstructive Sleep ApneaNCT03212209
Comparison of CPAP Modalities for OSA Treatment
A study testing CPAP Fixed Pressure in people with Obstructive Sleep Apnea, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
Trial summary
This is a crossover study comparing the effect of CPAP Fixed Pressure, CPAP FLEX -PLUS and Sensawake on sleep quality, adherence to treatments, and PSG parameters in patients with moderate to severe OSA. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP Fixed Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Apr 2017to 16 Jul 2018
- 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 30 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male gender
- apnea-hypopnea index (AHI) score of ≥20 events/hour of sleep
- 30-65 years-old
- body mass index (BMI) ≤40 Kg/m²
Who cannot join
- major neurological, psychiatric, cardiac or respiratory disease
- use of psychoactive medication
- other sleep disorders
- patients referred to PSG for Bilevel, considered the need for PAP ≥ 18 cm H2O
- Previous contact with any OSA treatment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Evelyn Brasil
São Paulo, 04024-002
Evelyn Brasil, Pt, +5511996357766, evelynlucien@yahoo.com.br
Dalva Poyares, MD,PhD, +5511985937418, poyares@unifesp.br
About this study
Official title: A Crossover Study Comparing Fixed Continuous Airway Positive Pressure, FLEX- PLUS and Sensawake Modalities for OSA Treatment
This is a crossover study comparing the effect of CPAP Fixed Pressure, CPAP FLEX -PLUS and Sensawake on sleep quality, adherence to treatments, and PSG parameters in patients with moderate to severe OSA.
Read the detailed description
Obstructive sleep apnea (OSA) is associated with behavioral, cognitive, metabolic and cardiovascular conditions. Continuous Positive Airway Pressure (CPAP) is the gold standard treatment for OSA. Despite being the most effective treatment for OSA, 46 to 83% of patients do not adhere to CPAP. New technologies for CPAP treatment have been developed in order to improve patient's comfort, adherence and effectiveness in reducing apnea, hypopneas and flow limitation events. As an example, the FLEX- PLUS technology which increases inspiratory positive pressure and decreases expiratory positive pressure would soften the rhythm of breathing. Sensawake is another technology which evaluates breathing pattern changes during CPAP therapy. When the breathing pattern suggests that patient is awake, a prompt relief in pressure is activated, like ramp feature. However, it is not clear whether CPAP FLEX- PLUS or Sensawake are superior compared with fixed pressure CPAP, in terms of polysomnographic parameters, especially flow limitation or adherence to treatment. Objective: To compare the effect of fixed pressure CPAP, CPAP FLEX- PLUS and Sensawake on sleep and compliance parameters in patients with moderate to severe OSA. Methods: Fifty male patients with moderate to severe OSA will be included in a crossover design study. All patients will use each CPAP modality for 30 days in a randomized order, namely CPAP with Fixed Pressure, Flex- PLUS and Sensawake. A week of washout period will be applied between treatments. All patients will wear the same nasal mask brand. At the end of each treatment (every 4 weeks), patients will undergo polysomnography and fill out Epworth, FOSQ, Pittsburgh questionnaires and a visual analogue scale assessing CPAP side effects and patient´s comfort. Finally, adherence to CPAP modalities will be systematically checked.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP Fixed Pressure
- Keywords
- Sleep Apnea, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP Fixed PressureDevice
Also called CPAP C- Flex Plus by Philips Respironics, CPAP with SensAwake by Fisher and Paykel
Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate and severe OSA, and it has been known to apply positive pressure in the upper airways, acting as a pneumatic splint preventing the upper airway collapse during sleep. CPAP C- Flex Plus by Philips - Respironics works just as CPAP Fixed Pressure, but increases the pressure delivered in the begining of inhalation to softens the breathing rhythm of the CPAP user. CPAP with SensAwake by Fisher and Paykel works just as CPAP fixed pressure but when the breathing pattern suggests that patient is awake, a prompt relief in pressure to the lowest most comfortable level is activated, like ramp feature.
| Study group | Role | What they receive |
|---|---|---|
| CPAP C- Flex-Plus by Philips Respironics | Experimental | Four consecutive weeks with CPAP C- FLEX PLUS treatment. After these 4 weeks, patients will undergo full PSG with CPAP FLEX- PLUS. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period. Receives: Device: CPAP Fixed Pressure |
| CPAP with Sensawake by Fisher and Paykel | Experimental | Four consecutive weeks with CPAP Sensawake treatment. After these 4 weeks, patients will undergo full PSG with the same CPAP modality. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period. Receives: Device: CPAP Fixed Pressure |
| CPAP fixed pressure | Active comparator | Four consecutive weeks with CPAP fixed pressure treatment. After these 4 weeks, patients will undergo full PSG with the same CPAP modality. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period. Receives: Device: CPAP Fixed Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow limitation
Flow limitation in percentage of total sleep time. The flow limitation will be assessed by the flow curve obtained in the polysomnographic recording.
Measured: 4 weeks after each CPAP modality completion
Secondary outcomes (3)
Adherence to CPAP treatment
Adherence to CPAP treatment will be evaluated by CPAP SD card download data
Measured: 4 weeks after each CPAP modality completion
Arousal index
Number of arousals per hour of sleep assessed by polysomnographic recording
Measured: 4 weeks after each CPAP modality completion
Wake time after sleep onset
Wake time after sleep onset assessed by polysomnographic recording
Measured: 4 weeks after each CPAP modality completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start28 Apr 2017
- Primary completion14 Feb 2018 (estimated)
- Study completion16 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Crossover
- Model description
- This is a crossover study comparing different CPAP modalities in a group of patients with moderate to severe OSA.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associação Fundo de Incentivo à Pesquisa
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare, Philips Respironics
- Responsible party
- Principal investigator, Dalva Poyares, Associação Fundo de Incentivo à Pesquisa
- Investigators
- Dalva Poyares, MD, PhD, Study director, AFIP - Associação de fundo e incentivo a pesquisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212209
- Sponsor's protocol ID
- AssociacaoFIP
- Status last verified
- Jul 2017
- First submitted
- 5 May 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: In case there is a future metanalysis in the subject, required by an indexed Journal or author.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Study Comparing Fixed Continuous Airway Positive Pressure, FLEX- PLUS and Sensawake Modalities for OSA Treatment
- ClinicalTrials.gov ID
- NCT03212209
- Acronym / sponsor ID
- AssociacaoFIP
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Sleep Apnea, CPAP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Associação Fundo de Incentivo à PesquisaUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare, Philips Respironics
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 14 Feb 2018 (estimated)
- Study completion
- 16 Jul 2018 (estimated)
- First posted
- 11 Jul 2017 (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.
This is a crossover study comparing the effect of CPAP Fixed Pressure, CPAP FLEX -PLUS and Sensawake on sleep quality, adherence to treatments, and PSG parameters in patients with moderate to severe OSA.
Detailed description
Obstructive sleep apnea (OSA) is associated with behavioral, cognitive, metabolic and cardiovascular conditions. Continuous Positive Airway Pressure (CPAP) is the gold standard treatment for OSA. Despite being the most effective treatment for OSA, 46 to 83% of patients do not adhere to CPAP. New technologies for CPAP treatment have been developed in order to improve patient's comfort, adherence and effectiveness in reducing apnea, hypopneas and flow limitation events. As an example, the FLEX- PLUS technology which increases inspiratory positive pressure and decreases expiratory positive pressure would soften the rhythm of breathing. Sensawake is another technology which evaluates breathing pattern changes during CPAP therapy. When the breathing pattern suggests that patient is awake, a prompt relief in pressure is activated, like ramp feature. However, it is not clear whether CPAP FLEX- PLUS or Sensawake are superior compared with fixed pressure CPAP, in terms of polysomnographic parameters, especially flow limitation or adherence to treatment. Objective: To compare the effect of fixed pressure CPAP, CPAP FLEX- PLUS and Sensawake on sleep and compliance parameters in patients with moderate to severe OSA. Methods: Fifty male patients with moderate to severe OSA will be included in a crossover design study. All patients will use each CPAP modality for 30 days in a randomized order, namely CPAP with Fixed Pressure, Flex- PLUS and Sensawake. A week of washout period will be applied between treatments. All patients will wear the same nasal mask brand. At the end of each treatment (every 4 weeks), patients will undergo polysomnography and fill out Epworth, FOSQ, Pittsburgh questionnaires and a visual analogue scale assessing CPAP side effects and patient´s comfort. Finally, adherence to CPAP modalities will be systematically checked.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This is a crossover study comparing different CPAP modalities in a group of patients with moderate to severe OSA.
| Arm | Type | Receives |
|---|---|---|
| CPAP C- Flex-Plus by Philips Respironics | Experimental | Device: CPAP Fixed PressureFour consecutive weeks with CPAP C- FLEX PLUS treatment. After these 4 weeks, patients will undergo full PSG with CPAP FLEX- PLUS. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period. |
| CPAP with Sensawake by Fisher and Paykel | Experimental | Device: CPAP Fixed PressureFour consecutive weeks with CPAP Sensawake treatment. After these 4 weeks, patients will undergo full PSG with the same CPAP modality. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period. |
| CPAP fixed pressure | Active comparator | Device: CPAP Fixed PressureFour consecutive weeks with CPAP fixed pressure treatment. After these 4 weeks, patients will undergo full PSG with the same CPAP modality. Patients will also fill out Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Functional Outcome Sleep Questionnaire, and visual analogue scale assessing CPAP side effects and patient´s comfort. Adherence to 4-week treatment will be checked. Treatment is followed by 7-day washout period. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male gender
- apnea-hypopnea index (AHI) score of ≥20 events/hour of sleep
- 30-65 years-old
- body mass index (BMI) ≤40 Kg/m²
Key exclusion criteria (5 listed)
- major neurological, psychiatric, cardiac or respiratory disease
- use of psychoactive medication
- other sleep disorders
- patients referred to PSG for Bilevel, considered the need for PAP ≥ 18 cm H2O
- Previous contact with any OSA treatment.
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 Fixed PressureAlso: CPAP C- Flex Plus by Philips Respironics, CPAP with SensAwake by Fisher and PaykelContinuous positive airway pressure (CPAP) is the gold standard treatment for moderate and severe OSA, and it has been known to apply positive pressure in the upper airways, acting as a pneumatic splint preventing the upper airway collapse during sleep. CPAP C- Flex Plus by Philips - Respironics works just as CPAP Fixed Pressure, but increases the pressure delivered in the begining of inhalation to softens the breathing rhythm of the CPAP user. CPAP with SensAwake by Fisher and Paykel works just as CPAP fixed pressure but when the breathing pattern suggests that patient is awake, a prompt relief in pressure to the lowest most comfortable level is activated, like ramp feature. | Device | CPAP C- Flex-Plus by Philips Respironics, CPAP fixed pressure, CPAP with Sensawake by Fisher and Paykel |
Primary outcome
Flow limitation
Time frame: 4 weeks after each CPAP modality completion
Flow limitation in percentage of total sleep time. The flow limitation will be assessed by the flow curve obtained in the polysomnographic recording.
3 secondary outcomes
Adherence to CPAP treatment
Time frame: 4 weeks after each CPAP modality completion
Arousal index
Time frame: 4 weeks after each CPAP modality completion
Wake time after sleep onset
Time frame: 4 weeks after each CPAP modality completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Individual participant dataSharing planned: Undecided. In case there is a future metanalysis in the subject, required by an indexed Journal or author.
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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.
Dalva Poyares, MD, PhD study director
AFIP - Associação de fundo e incentivo a pesquisa
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 Fixed Pressure in people with Obstructive Sleep Apnea, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
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 5 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 19 Dec 2017. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow limitation (time frame: 4 weeks after each CPAP modality completion). 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 19 Dec 2017.