Stroke Patients study: CPAP device vs Written Materials
Official title Stroke and CPAP Outcome Study 3 Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06722755
What this study is testing
- What it's testing
- This study wants to find out if a special support program helps stroke patients use their sleep apnea machines more often. It also checks if this extra help leads to better recovery from the stroke.
- Who it's for
- The study is looking for people who have had a stroke and also have obstructive sleep apnea (a condition where breathing stops during sleep).
- What's involved
- Participants will be randomly assigned to either a group that gets extra help with their machine or a group that gets standard care. The extra help includes technical support, counseling to boost motivation, and a mobile health app.
- Time commitment
- The study lasts about 3 months and involves tracking how often you use your machine and measuring your stroke recovery.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age 18 years or older
- Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days
- Person providing consent (patient or legally authorized representative (LAR)) able to be consented in English or Spanish.
You likely can't join if
- Unable to obtain informed consent from participant or LAR in English or Spanish
- Incarcerated
- Known pregnancy-determined by reviewing clinical data
- Current mechanical ventilation, tracheostomy, or supplemental oxygen use \> 4L/min
- Use of positive airway pressure within 14 days prior to stroke
- History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use
See the full eligibility criteria
- Age 18 years or older
- Head CT or brain MRI demonstrating an acute ischemic infarction or intraparenchymal hemorrhage within past 30 days
- Person providing consent (patient or legally authorized representative (LAR)) able to be consented in English or Spanish.
- Unable to obtain informed consent from participant or LAR in English or Spanish
- Incarcerated
- Known pregnancy-determined by reviewing clinical data
- Current mechanical ventilation, tracheostomy, or supplemental oxygen use \> 4L/min
- Use of positive airway pressure within 14 days prior to stroke
- History of pneumothorax, bullous emphysema or other serious co-morbid conditions which limit CPAP use
- Stroke related to tumors, vascular malformations or subarachnoid hemorrhage
- Active use of sedative drugs that can interfere with testing for obstructive sleep apnea (OSA) including any benzodiazepine, barbiturate, general anesthesia, or conscious sedation within the prior 48 hours of the...
- Anticipated inpatient rehabilitation length of stay \< 5 nights
- Co-morbid conditions that limit OSA testing or CPAP use in the judgement of the study team
- Recent cranial or spinal surgery with known or possible CSF leak or pneumocephalus within past 3 months
- Patients at significant risk of aspiration that could render the patient at risk of harm from use of CPAP, in the opinion of the site PI.
The study team makes the final eligibility decision.
Where it is enrolling
- Downey, California, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Downey, California, United States; Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.