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The feasibility of CPAP treatment in acute ischemic stroke patients - a pilot study

The feasibility of CPAP treatment in acute ischemic stroke patients - a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25487
Enrollment
10
Registered
2019-08-07
Start date
2019-08-13
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke

Interventions

Patients will receive CPAP within 24 hours after hospital admission, but at least 3 hours after alteplase infusion, during sleep and during the period of admission to the hospital.

Sponsors

ZonMW, Mediq
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patiënt had first ever ischemic stroke > 18 years old onset < 4.5hours anterior circulation

Exclusion criteria

Exclusion criteria: history of stroke history of obstructive sleep apnea hemorrhagic stroke TIA

Design outcomes

Primary

MeasureTime frame
The primary endpoint is feasibility defined as CPAP compliance during the study period. Compliance is expressed as the average use of CPAP per night measured by a memory card integrated in the CPAP device. Good compliance will be defined as an average usage of more than 4 hours per night.

Secondary

MeasureTime frame
- Inclusion rate - Adverse events (AE): CPAP related AEs as mentioned in section 3.5 - Percentage of withdrawal from CPAP treatment - Self-evaluation of CPAP by patients and their caregivers - Functional status: The National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS) - Cognitive status: Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT) - OSA prevalence measured by polysomnography (PSG) - Epworth Sleepiness Scale (ESS)

Contacts

Public ContactMyrthe Willems

OLVG

m.willems@olvg.nl0205108780

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)