Impact of Early Ventilation in Stroke Outcomes in Patients With Sleep Apnea After First Ever Stroke

NCT04903951 | Recruiting Phase 2

• 1 other identifier: PSASV-01-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the impact of early ventilation in stroke outcomes in patients with sleep apnea and first ever stroke, 1 month after stroke.

Conditions

Stroke; Sleep Apnea

Keywords

stroke; early ventilation; sleep apnea

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with improvement in neurological parameters (reduction of ≥1 point from the beginning in Rankin scale) 1 month after stroke.

  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.

  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.

  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™

  Within 7 days after admission

• Adherence in the Servoventilation group

  After 1, 4 and 6 months

• Efficacy in the Servoventilation group

  After 1, 4 and 6 months

Study Arms (2)

ASV therapy + best medical treatment for stroke, including rehabilitation

EXPERIMENTAL

Adaptive Servoventilation (ASV) therapy plus best medical treatment for stroke, including rehabilitation.

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.

Other: Best medical treatment

Interventions

Adaptive Servoventilation (ASV) therapy DEVICE

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

ASV therapy + best medical treatment for stroke, including rehabilitation

Best medical treatment OTHER

Best medical treatment for stroke, including rehabilitation

ASV therapy + best medical treatment for stroke, including rehabilitation; Best medical treatment for stroke, including rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Philips Portuguesa S.A.: lead

Study Sites (1)

Unidade Local de Saúde de Matosinhos

Matosinhos Municipality, Portugal

RECRUITING

MeSH Terms

Conditions

Stroke; Sleep Apnea Syndromes; Respiratory Aspiration

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sílvia Correia, MD

  Trofa Saúde Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sílvia Correia, MD

CONTACT

00351969043466; silviapaiscorreia@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 27, 2021
• Study Start: February 27, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)