Prevention Of Delirium in Elderly With Obstructive Sleep Apnea (PODESA) (PODESA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02954224
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : November 3, 2016
Information provided by (Responsible Party):
Jean Wong, University Health Network, Toronto

Brief Summary:
Delirium is a common complication in elderly patients following surgery. Patients who develop delirium after surgery are at increased risk for serious complications, and even death.This multi-centre randomized controlled trial will enroll elderly patients scheduled for elective hip/knee replacement surgery.The objective of this trial is to identify obstructive sleep apnea using ApneaLink Air and to determine whether auto-titrating CPAP treatment of obstructive sleep apnea will decrease the incidence of post-operative delirium in elderly patients undergoing elective hip and knee replacement surgery.

Condition or disease Intervention/treatment
Sleep Apnea Other: CPAP treatment

Detailed Description:
Delirium is an acute and fluctuating change in cognitive function, characterized by poor attention and disorganized thinking. Recent studies show that patients with obstructive sleep apnea (OSA) - a sleep disorder characterized by repeated episodes of complete or partial blockage of the upper airway - are at greater risk to develop delirium. It is estimated that 43% of men and 27% of women aged 50-70 years old have OSA. Elderly individuals with this condition are often undiagnosed. Unrecognized OSA may be a treatable cause of postoperative delirium. However, timely access to polysomnography is usually not possible prior to surgery. This multi-centre randomized controlled trial will enroll elderly patients scheduled for elective hip/knee replacement surgery. All participants who have given the consent to participate will be assessed risks of OSA and comorbidity by 3 basic questionnaires- STOP-Bang, Epworth Sleepiness Scale and Charlson Comorbidity index, Cognitive level assess by Mini-Cog and baseline delirium assessment by CAM. STOP-Bang questionnaire is the validated questionnaire to screen the patients for OSA. Score of 3 or higher has sensitivity of detecting OSA of 93% and 100% for moderate and severe OSA respectively. If participant has STOP-Bang score 3 or higher will have a home sleep study with the ApneaLink Air and overnight oximetry. Patients identified to have OSA(AHI ≥10/h) will be randomized to 1) Auto-titrating continuous positive airway pressure (CPAP) applied 1-3 nights before surgery (if possible) and during day/night sleep for 72 hrs after surgery or 2) Control group - routine care. All patients will be evaluated for delirium for 72h after surgery.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Prevention Of Delirium in Elderly With Obstructive Sleep Apnea (PODESA)
Study Start Date : March 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CPAP therapy arm
Auto-titrating Continuous Positive Airway Pressure (CPAP)) treatment will be given on postoperative days 1, 2, and 3.
Other: CPAP treatment
Patients who are randomized to auto-titrating CPAP will use an auto CPAP device on postoperative days 1, 2, and 3
No Intervention: Control arm
no auto-titrating CPAP, standard care

Primary Outcome Measures :
  1. postoperative delirium [ Time Frame: 2 MONTHS ]
    The primary outcome is the incidence of postoperative delirium.

Secondary Outcome Measures :
  1. Length of Hospital Stay [ Time Frame: Depending on post operative recovery(2 days-2 months) ]
    This parameter depends on post operative recovery

  2. Time to ambulate [ Time Frame: 1 week to 2 months ]
    This parameter depending on lots of factors( eg; physiotherapy, weight, attitudes, other medical conditions ect...)

  3. Perioperative Complications [ Time Frame: 10-14 days ]
    Post operative complications include ICU admissions, hypoxia, re-intubation, Myocardial Infarctions, Wound Infections, Deep Vein Thrombosis, Pneumonia, Sepsis, Urinary Tract Infection, Stroke, etc..)

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

  • Age more than 60 years, Scheduled for elective hip or knee replacement surgery at least 4 working days after the preadmission clinic visit
  • Possess cognitive and physical capability necessary to comprehend and complete the study questionnaires
  • Proficient in English, reading level at Grade 6 (patient or accompanying person),
  • Be accessible for follow-up via telephone, or via the Internet, Ability to provide informed consent

Exclusion criteria

  • Conditions potentially interfering with comprehension and delivery of informed consent , Schizophrenia, anxiety disorders, poorly controlled depression, multiple psychiatric disorders
  • Active psychosis within the last 3 months
  • Current use of antipsychotic medication
  • Dementia, and/or clinically significant neurological disorder (stroke, epilepsy, brain tumors, Parkinson's Disease etc.)
  • History of drug or alcohol dependence or abuse within last 3 months
  • Surgery that is two-staged involving more than one surgical procedure to be performed within the same hospitalization period
  • Emergency surgery when preoperative testing is not possible
  • Patients with prior diagnosis of sleep-related breathing disorder with CPAP treatment
  • Patients who may have had sleep studies earlier may be included, if they have been lost to follow-up by a sleep physician, are not on treatment or are non-compliant to treatment (mean CPAP nightly use <4 hours, or median nightly CPAP use <50% of total sleep time),Severe tracheal or lung disease,Contraindication to CPAP face-mask, Central Sleep Apnea, Significant Cardiac disease(New York Heart Association Functional Class III and IV Severe Valvular Heart Disease, Dilated Cardiomyopathy, Implanted Cardiac Pacemaker, unstable angina)
  • bMyocardial Infarction or Cardiac Surgery or Percutaneous coronary interventions within 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02954224

Contact: jean wong, MD 4166035118
Contact: Asmita Bhoite, CRA

Canada, Ontario
Sunnybrook Hospital Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Kathrina Flores   
Contact: Nishanthi Liyanage, CRA    416-603-5800 ext 3959   
Principal Investigator: Stephen Choi, MD         
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Nishanthi Liyanage, CRA    416035800 ext 3959   
Principal Investigator: Jean Wong, MD         
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada
Contact: Asmita Bhoite, CRA   
Contact: Nishanthi Liyanage, CRA    416-603-5800 ext 3959   
Principal Investigator: Naveed Siddiqui, MD         
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Jean Wong, MD University Health Network, Toronto

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jean Wong, Dr., University Health Network, Toronto Identifier: NCT02954224     History of Changes
Other Study ID Numbers: 2014-0122-B
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jean Wong, University Health Network, Toronto:
sleep apnea, delirium

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Neurocognitive Disorders
Mental Disorders