StrokePhase 2NCT04903951
Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke
A Phase 2 study testing Adaptive Servoventilation (ASV) therapy and Best medical treatment in people with Stroke and Sleep Apnea, run by Philips Portuguesa S.A. at 1 site in Portugal.
Trial summary
To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Sleep Apnea
- What is being tested?
- Adaptive Servoventilation (ASV) therapy and Best medical treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- 27 Feb 2024to Aug 2025
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained from the participant or the legally acceptable representative, prior to any study-related procedure.
- Male or female between 18 and 80 years, inclusive, at the time of signing the informed consent.
- Admission to the hospital within 48 h of stroke symptoms onset.
- Ischemic first stroke diagnosis.
- NIHSS ≥2 at screening.
- Sleep apnea with AHI ≥15.
Who cannot join
- CSA with Left Ventricular Ejection Fraction ⩽45%.
- Ventilation treatment for sleep apnea diagnosis, prior to stroke.
- Risk of aspiration.
- Nasogastric feeding tube.
- Transient ischemic attack, hemorrhagic stroke or subarachnoid hemorrhage.
- Stroke due to a secondary cause (e.g. vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding).
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- Cardiorespiratory distress.
- Advanced chronic lung disease requiring supplemental oxygen.
- Concomitant central nervous system diseases such as dementia or multiple sclerosis.
- Uncontrolled psychosis or agitation.
- Glasgow Coma Scale (GCS) score <10 at screening.
- Anosognosia, global or Wernicke aphasia.
- Insufficient upper limbs function to use a mask and no overnight caregiver to help.
- Inability to attend to the rehabilitation program of the hospital.
- Pregnant and breast-feeding women.
- Participation in another clinical study (except a standard-of-care registry).
- Any other condition that, according to the Investigator, renders the subject unsuitable for ventilation.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Unidade Local de Saúde de Matosinhos
Matosinhos Municipality
Sílvia Correia, MD
About this study
Official title: A Single-center, Randomized, Open Label, Parallel Arm, Prospective Study to Evaluate the Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke
To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after stroke.
Read the detailed description
Single-center, randomized, open label, parallel arm, prospective study in patients with sleep apnea after first-ever stroke.
The study will consist of screening, baseline assessment, interventional period (consisting of a treatment period and follow-up visits), and a follow-up phone call.
Patients will be randomly assigned to ASV (active) or control groups, within 4 days after the PSG II and will start the respective intervention in the same day.
Patients assigned to the active group will receive ventilatory support with ASV (DreamStation BiPAP autoSV®) during diurnal and nocturnal sleep, from study randomization until clinically indicated. Patients assigned to control group will receive best medical treatment for stroke alone, including rehabilitation.
- Conditions
- Stroke, Sleep Apnea
- Being tested
- Adaptive Servoventilation (ASV) therapy, Best medical treatment
- Keywords
- stroke, early ventilation, sleep apnea
- Medical subject headings
- Stroke, Sleep Apnea Syndromes, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Servoventilation (ASV) therapyDevice
Patients assigned to the active group will receive ventilatory support with ASV (DreamStation BiPAP autoSV®) during diurnal and nocturnal sleep, from study randomization until clinically indicated
Best medical treatmentOther
Best medical treatment for stroke, including rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| ASV therapy + best medical treatment for stroke, including rehabilitation | Experimental | Adaptive Servoventilation (ASV) therapy plus best medical treatment for stroke, including rehabilitation. Receives: Device: Adaptive Servoventilation (ASV) therapy; Other: Best medical treatment |
| Best medical treatment for stroke, including rehabilitation | Active comparator | Best medical treatment for stroke, including rehabilitation. Receives: Other: Best medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) 1 month after stroke.
Measured: 1 month after stroke
Secondary outcomes (8)
Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) at 4 and 6 months after stroke.
Measured: 4 and 6 months after stroke
Change from baseline in National Institutes of Health Stroke Scale (NIHSS) to measure improvement in neurological parameters at month 1, 4 and 6 after stroke.
Measured: 1, 4 and 6 months after stroke
Type II full polysomnography (PSG II) within 7 days of stroke symptoms onset in all patients with AHI >5 as assessed by ApneaLink™
Measured: Within 7 days after admission
Adherence in the Servoventilation group
% nights of device use; average hours per night of device use
Measured: After 1, 4 and 6 months
Efficacy in the Servoventilation group
Apnea-Hypopnea Index
Measured: After 1, 4 and 6 months
Adverse events monitoring
All AEs occurring within the period of observation for the clinical study must be fully evaluated, documented, reported (if applicable) and archived.
Measured: Through study completion, an average of 2 years
Cardiovascular events evaluation at month 1, 4 and 6 months after stroke in randomized patients
Measured: 1, 4 and 6 months after stroke
Cardiovascular events evaluation 12 months after stroke in all participants.
Measured: 12 months after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start27 Feb 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Portuguesa S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Sílvia Correia, Philips Portuguesa S.A.
- Investigators
- Sílvia Correia, MD, Principal investigator, Trofa Saúde Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903951
- Sponsor's protocol ID
- PSASV-01-01
- Status last verified
- Aug 2024
- First submitted
- 17 May 2021
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Open Label, Parallel Arm, Prospective Study to Evaluate the Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke
- ClinicalTrials.gov ID
- NCT04903951
- Acronym / sponsor ID
- PSASV-01-01
- Conditions
- Stroke, Sleep Apnea
- Keywords
- stroke, early ventilation, sleep apnea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Philips Portuguesa S.A.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 27 May 2021 (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.
To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after stroke.
Detailed description
Single-center, randomized, open label, parallel arm, prospective study in patients with sleep apnea after first-ever stroke.
The study will consist of screening, baseline assessment, interventional period (consisting of a treatment period and follow-up visits), and a follow-up phone call.
Patients will be randomly assigned to ASV (active) or control groups, within 4 days after the PSG II and will start the respective intervention in the same day.
Patients assigned to the active group will receive ventilatory support with ASV (DreamStation BiPAP autoSV®) during diurnal and nocturnal sleep, from study randomization until clinically indicated. Patients assigned to control group will receive best medical treatment for stroke alone, including rehabilitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASV therapy + best medical treatment for stroke, including rehabilitation | Experimental | Device: Adaptive Servoventilation (ASV) therapy, Other: Best medical treatmentAdaptive Servoventilation (ASV) therapy plus best medical treatment for stroke, including rehabilitation. |
| Best medical treatment for stroke, including rehabilitation | Active comparator | Other: Best medical treatmentBest medical treatment for stroke, including rehabilitation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent obtained from the participant or the legally acceptable representative, prior to any study-related procedure.
- Male or female between 18 and 80 years, inclusive, at the time of signing the informed consent.
- Admission to the hospital within 48 h of stroke symptoms onset.
- Ischemic first stroke diagnosis.
- NIHSS ≥2 at screening.
Key exclusion criteria (17 listed)
- CSA with Left Ventricular Ejection Fraction ⩽45%.
- Ventilation treatment for sleep apnea diagnosis, prior to stroke.
- Risk of aspiration.
- Nasogastric feeding tube.
- Transient ischemic attack, hemorrhagic stroke or subarachnoid hemorrhage.
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 |
|---|---|---|
| Adaptive Servoventilation (ASV) therapyPatients assigned to the active group will receive ventilatory support with ASV (DreamStation BiPAP autoSV®) during diurnal and nocturnal sleep, from study randomization until clinically indicated | Device | ASV therapy + best medical treatment for stroke, including rehabilitation |
| Best medical treatmentBest medical treatment for stroke, including rehabilitation | Other | ASV therapy + best medical treatment for stroke, including rehabilitation, Best medical treatment for stroke, including rehabilitation |
Primary outcome
Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) 1 month after stroke.
Time frame: 1 month after stroke
8 secondary outcomes
Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) at 4 and 6 months after stroke.
Time frame: 4 and 6 months after stroke
Change from baseline in National Institutes of Health Stroke Scale (NIHSS) to measure improvement in neurological parameters at month 1, 4 and 6 after stroke.
Time frame: 1, 4 and 6 months after stroke
Type II full polysomnography (PSG II) within 7 days of stroke symptoms onset in all patients with AHI >5 as assessed by ApneaLink™
Time frame: Within 7 days after admission
Adherence in the Servoventilation group
Time frame: After 1, 4 and 6 months
Efficacy in the Servoventilation group
Time frame: After 1, 4 and 6 months
Adverse events monitoring
Time frame: Through study completion, an average of 2 years
Cardiovascular events evaluation at month 1, 4 and 6 months after stroke in randomized patients
Time frame: 1, 4 and 6 months after stroke
Cardiovascular events evaluation 12 months after stroke in all participants.
Time frame: 12 months after stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Sílvia Correia, MD principal investigator
Trofa Saúde Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adaptive Servoventilation (ASV) therapy and Best medical treatment in people with Stroke and Sleep Apnea, run by Philips Portuguesa S.A. at 1 site in Portugal.
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 6 inclusion and 17 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 12 Aug 2024. 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 Portugal. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Sílvia Correia, MD (00351969043466, silviapaiscorreia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) 1 month after stroke. (time frame: 1 month after stroke). 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 Aug 2024.