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Effect Of Early C-PAP Treatment For Sleep Apnea On Rehabilitation Of Stroke Patients

NCT02426424 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2018-04-19

No results posted yet for this study

Summary

This is a prospective randomized open label trial with control-to-treatment cross-over. The investigators wish to assess the effectiveness and safety of immediate detection and treatment for Sleep Apnea in Stroke patients. The investigators hypothesize that in patients with acute ischemic stroke a sleep apnea treatment by CPAP will result in a better neurological outcome and more successful rehabilitation.

The study will enroll 140 subjects which will be randomized into one of two arms:

* Investigational - The sleep study will be performed during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge.
* Control group -Will receive standard medical care. Patients will undergo sleep study at 3 months following discharge and patients diagnosed with sleep apnea will be treated with C-PAP.

Conditions

Interventions

DEVICE

Watchpat

WatchPAT ™ is an FDA-approved portable diagnostic device that uses the most innovative technology to ensure the accurate screening, detection, and the follow-up treatment of sleep apnea.

DEVICE

CPAP

Continuous positive airway pressure (CPAP) is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in a patient who is able to breathe spontaneously on his or her own.

Sponsors & Collaborators

  • Soroka University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2020-06-30
Completion
2020-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02426424 on ClinicalTrials.gov