Evaluating early ventilation effects on stroke recovery in patients with sleep apnea

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

This study is testing if using a special breathing machine early on can help people with sleep apnea recover better after their first stroke.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Philips Portuguesa S.A. (Industry-sponsored)
• Locations: 1 site (Matosinhos Municipality)
• Trial ID: NCT04903951 on ClinicalTrials.gov

What this trial studies

This study aims to assess the impact of early ventilation using Adaptive Servoventilation (ASV) on the recovery outcomes of patients who have experienced their first-ever ischemic stroke and have sleep apnea. It is a single-center, randomized, open-label trial where participants will be assigned to either receive ASV therapy or standard medical treatment for stroke. The intervention will begin within four days of stroke onset and will continue until clinically indicated, with follow-up assessments conducted one month post-stroke. The study will involve screening, baseline assessments, and follow-up visits to evaluate the effectiveness of the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who have experienced their first ischemic stroke and have a diagnosis of sleep apnea.

Not a fit: Patients with conditions such as advanced chronic lung disease or those requiring prior ventilation treatment for sleep apnea may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for stroke patients with sleep apnea.

How similar studies have performed: While this approach is innovative, similar studies have shown promising results in improving outcomes for patients with sleep apnea and other conditions.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent obtained from the participant or the legally acceptable representative, prior to any study-related procedure.
2. Male or female between 18 and 80 years, inclusive, at the time of signing the informed consent.
3. Admission to the hospital within 48 h of stroke symptoms onset.
4. Ischemic first stroke diagnosis.
5. NIHSS ≥2 at screening.
6. Sleep apnea with AHI ≥15.

Exclusion Criteria:

1. CSA with Left Ventricular Ejection Fraction ⩽45%.
2. Ventilation treatment for sleep apnea diagnosis, prior to stroke.
3. Risk of aspiration.
4. Nasogastric feeding tube.
5. Transient ischemic attack, hemorrhagic stroke or subarachnoid hemorrhage.
6. Stroke due to a secondary cause (e.g. vascular malformation, vasculitis, brain tumor, head trauma, or predisposition to bleeding).
7. Cardiorespiratory distress.
8. Advanced chronic lung disease requiring supplemental oxygen.
9. Concomitant central nervous system diseases such as dementia or multiple sclerosis.
10. Uncontrolled psychosis or agitation.
11. Glasgow Coma Scale (GCS) score \<10 at screening.
12. Anosognosia, global or Wernicke aphasia.
13. Insufficient upper limbs function to use a mask and no overnight caregiver to help.
14. Inability to attend to the rehabilitation program of the hospital.
15. Pregnant and breast-feeding women.
16. Participation in another clinical study (except a standard-of-care registry).
17. Any other condition that, according to the Investigator, renders the subject unsuitable for ventilation.

Where this trial is running

Matosinhos Municipality

• Unidade Local de Saúde de Matosinhos — Matosinhos Municipality, Portugal (Recruiting)

Study contacts

• Principal investigator: Sílvia Correia, MD — Trofa Saúde Hospital
• Study coordinator: Sílvia Correia, MD

Conditions Stroke; Sleep Apnea; stroke; early ventilation; sleep apnea