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

Primary Purpose

Stroke, Sleep Apnea

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Adaptive Servoventilation (ASV) therapy

Best medical treatment

About this trial

This is an interventional prevention trial for Stroke focused on measuring stroke, early ventilation, sleep apnea

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ASV therapy + best medical treatment for stroke, including rehabilitation

Best medical treatment for stroke, including rehabilitation

Arm Description

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

Best medical treatment for stroke, including rehabilitation.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

Type II full polysomnography (PSG II) within 7 days of stroke symptoms onset in all patients with AHI >5 as assessed by ApneaLink™

Adherence in the Servoventilation group

% nights of device use; average hours per night of device use

Efficacy in the Servoventilation group

Apnea-Hypopnea Index

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.

Cardiovascular events evaluation at month 1, 4 and 6 months after stroke in randomized patients

Cardiovascular events evaluation 12 months after stroke in all participants.

Full Information

NCT ID

NCT04903951

First Posted

May 17, 2021

Last Updated

April 20, 2022

Sponsor

Philips Portuguesa S.A.

1. Study Identification

Unique Protocol Identification Number

NCT04903951

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 2022 (Anticipated)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Philips Portuguesa S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Sleep Apnea

Keywords

stroke, early ventilation, sleep apnea

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ASV therapy + best medical treatment for stroke, including rehabilitation

Arm Type

Experimental

Arm Description

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

Arm Title

Best medical treatment for stroke, including rehabilitation

Arm Type

Active Comparator

Arm Description

Best medical treatment for stroke, including rehabilitation.

Intervention Type

Device

Intervention Name(s)

Adaptive Servoventilation (ASV) therapy

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Best medical treatment

Intervention Description

Best medical treatment for stroke, including rehabilitation

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Title

Adherence in the Servoventilation group

Description

% nights of device use; average hours per night of device use

Time Frame

After 1, 4 and 6 months

Title

Efficacy in the Servoventilation group

Description

Apnea-Hypopnea Index

Time Frame

After 1, 4 and 6 months

Title

Adverse events monitoring

Description

All AEs occurring within the period of observation for the clinical study must be fully evaluated, documented, reported (if applicable) and archived.

Time Frame

Through study completion, an average of 2 years

Title

Cardiovascular events evaluation at month 1, 4 and 6 months after stroke in randomized patients

Time Frame

1, 4 and 6 months after stroke

Title

Cardiovascular events evaluation 12 months after stroke in all participants.

Time Frame

12 months after stroke

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sílvia Correia, MD

Phone

00351969043466

silviapaiscorreia@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sílvia Correia, MD

Organizational Affiliation

Hospital Pedro Hispano, ULS Matosinhos

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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