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

NCT02426424 | Withdrawn Phase 4

• 1 other identifier: SOR-0305-14-ctil
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Sleep Apnea; Stroke

Keywords

c-PAP

Outcome Measures

Primary Outcomes (1)

• NIHSS change from the baseline to 3 months

  Change in the NIHSS score from admission to three months

  3 months

Secondary Outcomes (10)

• NIHSS change score from admission to discharge from the Neurology Department.

  3 months

• NIHSS score change from admission to 6 months following hospitalization

  6 months

• NIHSS score change from three to six months following hospitalization

  6 month

• Prevent recurrent strokes at 6 months

  6 months

• Analyse the composite of cardiovascular events at 6 months (acute myocardial infarction, coronary revascularization, death or recurrent stroke)

  6 months

Study Arms (2)

Investigatory 1

EXPERIMENTAL

The sleep study will be performed via Watchpat 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 for three months.

Device: Watchpat; Device: CPAP

Investigatory 2

EXPERIMENTAL

The sleep study will be performed via Watchpat at home three months after hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP for three months.

Device: Watchpat; Device: CPAP

Interventions

Watchpat DEVICE

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.

Investigatory 1; Investigatory 2

CPAP DEVICE

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.

Investigatory 1; Investigatory 2

Eligibility Criteria

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

You may qualify if:

• Patients over the age of 18.
• Admitted to the Neurology Department due to acute ischemic stroke.
• Able to sign informed consent.
• Admission NIHSS 6-12.

You may not qualify if:

• Stroke symptom onset more than 72 hours prior to the enrollment
• Transient Ischemic Attack.
• Chronic pulmonary disease requiring home oxygen treatment.
• History of C-PAP treatment

Sponsors & Collaborators

• Soroka University Medical Center: lead

MeSH Terms

Conditions

Sleep Apnea Syndromes; Stroke

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology Department

Study Record Dates

• First Submitted: December 24, 2014
• First Posted: April 27, 2015
• Study Start: January 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 19, 2018

Record last verified: 2018-04