Obstructive Sleep Apnea SyndromeNCT02522819
Feasibility Evaluation of CPAP in the Treatment of Obstructive Sleep Apnea Synchrone in the Acute Phase of Stroke
A study testing CPAP in people with Obstructive Sleep Apnea Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
This project is focused on the treatment of obstructive sleep apnea in the acute phase of stroke. Stroke is a frequent pathology with a high morbidity and mortality rate. Although it has now been proved that obstructive sleep apnea syndrome (OSAS) is a risk factor of stroke, on the other hand, there is evidence that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Nov 2014
- 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
- - Clinical presentation of ischemic stroke confirmed by imaging (CT or MRI brain scan)
- less than 24 hours from onset of symptoms
- admitted to the Neurovascular unit of the Emergency Hospitalisation Department of 'Hôpital Nord' of the university hospital of Saint-Étienne
- presenting obstructive sleep apnea syndrome (defined as an apnea-hypopnea index (AHI) of ≥ 10 and > 50% of obstructive events)
- written consent of patient
Who cannot join
- Concussion (Coma Glasgow Score <12)
- Comprehension aphasia
- Uncontrollable confusion and agitation
- History of dementia
- History of ischemic stroke with neurological damage
- History of hemorrhagic stroke
Show all 20Show fewer
- History of epilepsy
- Cerebrospinal fluid leak, recent cranial surgery or head injury
- Serious bullous lung disease
- Hypoxic pulmonary disease
- Pleurisy or pneumothorax requiring draining
- Respiratory distress requiring mechanical ventilation
- Oxygen therapy prior to stroke
- Non-invasive ventilation therapy prior to stroke
- Hypotension
- Dehydration
- Hypersalivation
- Vomiting
- Pregnancy, parturients, breast feeding
- Absence of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Evaluation of Continuous Positive Airway Pressure (CPAP) in the Treatment of Obstructive Sleep Apnea Synchrone in the Acute Phase of Stroke
This project is focused on the treatment of obstructive sleep apnea in the acute phase of stroke. Stroke is a frequent pathology with a high morbidity and mortality rate. Although it has now been proved that obstructive sleep apnea syndrome (OSAS) is a risk factor of stroke, on the other hand, there is evidence that 50 to 70% of patients in the acute phase of stroke have obstructive sleep apnea (OSA) based on an apnea-hypopnea index (AHI) of ≥ 10. OSA is associated with worse functional outcomes and higher mortality in the post-stroke period. Profound hemodynamic fluctuations and hypoxia generated by sleep apnea are likely to aggravate cerebral ischemia, particularly in the acute phase of stroke in the potentially reversible ischemic penumbra. Continuous Positive Airway Pressure (CPAP) is the primary treatment for obstructive sleep apnea.
Yet, to our knowledge, there have been very few studies aimed at demonstrating the value of CPAP in the treatment of obstructive sleep apnea in the acute phase of stroke. Only one randomised trial has provided the means to document neurological improvement at mid term (1 month) in a targeted population.
Before undertaking a comparative study evaluating the efficacy of CPAP in the acute phase of ischemic stroke, it is worth evaluating the feasibility and tolerance of introducing CPAP at the very early stage of ischemic stroke. Therefore, the purpose of our study is to evaluate the feasibility of CPAP in the treatment of OSA in the acute phase of ischemic stroke.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- CPAP
- Keywords
- Obstructive Sleep Apnea Syndrome, acute stroke, apnea-hypopnea index (AHI)
- Medical subject headings
- Sleep Apnea, Obstructive, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Use of CPAP over 5 nights for the treatment of obstructive sleep apnea in the acute phase of stroke.
| Study group | Role | What they receive |
|---|---|---|
| obstructive sleep apnea in the acute phase of stroke | Experimental | Use of CPAP over 5 nights for the treatment of obstructive sleep apnea in the acute phase of stroke Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP feasibility
Number of patients for which CPAP is used for a minimum of 3 hours per night over 5 nights. CPAP feasibility is retained if at least 50% of all patients have had the use of CPAP for at least 3 hours per night over 5 nights.
Measured: day 5
Secondary outcomes (3)
Feasibility of the ventilatory polygraph
Number of readable polygraph recordings. A readable recording is defined as a minimum duration of 6 hours of recording with signals of a sufficient quality.
Measured: night 1
Tolerance of CPAP by patient per night
Evaluation of CPAP tolerance according to a score as per the VAS (Visual Analogue Scale) for pain ranging from 0: "No tolerance" to 10: "Excellent tolerance" per night of use of CPAP device
Measured: 5 nights
Number of hypotensive episodes per night per patient
Number of hypotensive episodes per night per patient by non-invasive measuring of blood pressure during the period of use of the CPAP device and defined according to systolic BP of < 90 mm Hg or drop of 40 mmHg with respect to the basic parameter.
Measured: 5 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startOct 2011
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard TARDY, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522819
- Sponsor's protocol ID
- 1108101
- Status last verified
- Aug 2015
- First submitted
- 12 Aug 2015
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Evaluation of Continuous Positive Airway Pressure (CPAP) in the Treatment of Obstructive Sleep Apnea Synchrone in the Acute Phase of Stroke
- ClinicalTrials.gov ID
- NCT02522819
- Acronym / sponsor ID
- 1108101
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Obstructive Sleep Apnea Syndrome, acute stroke, apnea-hypopnea index (AHI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Aug 2015 (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.
This project is focused on the treatment of obstructive sleep apnea in the acute phase of stroke. Stroke is a frequent pathology with a high morbidity and mortality rate. Although it has now been proved that obstructive sleep apnea syndrome (OSAS) is a risk factor of stroke, on the other hand, there is evidence that 50 to 70% of patients in the acute phase of stroke have obstructive sleep apnea (OSA) based on an apnea-hypopnea index (AHI) of ≥ 10. OSA is associated with worse functional outcomes and higher mortality in the post-stroke period. Profound hemodynamic fluctuations and hypoxia generated by sleep apnea are likely to aggravate cerebral ischemia, particularly in the acute phase of stroke in the potentially reversible ischemic penumbra. Continuous Positive Airway Pressure (CPAP) is the primary treatment for obstructive sleep apnea.
Yet, to our knowledge, there have been very few studies aimed at demonstrating the value of CPAP in the treatment of obstructive sleep apnea in the acute phase of stroke. Only one randomised trial has provided the means to document neurological improvement at mid term (1 month) in a targeted population.
Before undertaking a comparative study evaluating the efficacy of CPAP in the acute phase of ischemic stroke, it is worth evaluating the feasibility and tolerance of introducing CPAP at the very early stage of ischemic stroke. Therefore, the purpose of our study is to evaluate the feasibility of CPAP in the treatment of OSA in the acute phase of ischemic stroke.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obstructive sleep apnea in the acute phase of stroke | Experimental | Device: CPAPUse of CPAP over 5 nights for the treatment of obstructive sleep apnea in the acute phase of stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - Clinical presentation of ischemic stroke confirmed by imaging (CT or MRI brain scan)
- less than 24 hours from onset of symptoms
- admitted to the Neurovascular unit of the Emergency Hospitalisation Department of 'Hôpital Nord' of the university hospital of Saint-Étienne
- presenting obstructive sleep apnea syndrome (defined as an apnea-hypopnea index (AHI) of ≥ 10 and > 50% of obstructive events)
- written consent of patient
Key exclusion criteria (20 listed)
- Concussion (Coma Glasgow Score <12)
- Comprehension aphasia
- Uncontrollable confusion and agitation
- History of dementia
- History of ischemic stroke with neurological damage
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 |
|---|---|---|
| CPAPUse of CPAP over 5 nights for the treatment of obstructive sleep apnea in the acute phase of stroke. | Device | obstructive sleep apnea in the acute phase of stroke |
Primary outcome
CPAP feasibility
Time frame: day 5
Number of patients for which CPAP is used for a minimum of 3 hours per night over 5 nights. CPAP feasibility is retained if at least 50% of all patients have had the use of CPAP for at least 3 hours per night over 5 nights.
3 secondary outcomes
Feasibility of the ventilatory polygraph
Time frame: night 1
Tolerance of CPAP by patient per night
Time frame: 5 nights
Number of hypotensive episodes per night per patient
Time frame: 5 nights
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 13 Aug 2015.
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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.
Bernard TARDY, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 in people with Obstructive Sleep Apnea Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 5 inclusion and 20 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 13 Aug 2015. 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 France. 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?
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?
CPAP feasibility (time frame: day 5). 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 13 Aug 2015.