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Sleep ApneaPODESANCT02954224

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

A study testing CPAP treatment in people with Sleep Apnea, run by University Health Network, Toronto at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Sleep Apnea
What is being tested?
CPAP treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
3 sitesCanada
Study dates
24 Mar 2016to 30 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Mount Sinai Hospital

    Toronto, Ontario

Other trials in Canada

About this study

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.

Read the 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.

Conditions
Sleep Apnea
Being tested
CPAP treatment
Keywords
sleep apnea, delirium
Medical subject headings
Sleep Apnea Syndromes, Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPAP treatmentOther

    Patients who are randomized to auto-titrating CPAP will use an auto CPAP device on postoperative days 1, 2, and 3

Study groups in NCT02954224
Study groupRoleWhat they receive
CPAP therapy armExperimentalAuto-titrating Continuous Positive Airway Pressure (CPAP)) treatment will be given on postoperative days 1, 2, and 3.
Receives: Other: CPAP treatment
Control armNo interventionno auto-titrating CPAP, standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative delirium

    The primary outcome is the incidence of postoperative delirium.

    Measured: 2 MONTHS

Secondary outcomes (3)

  1. Length of Hospital Stay

    This parameter depends on post operative recovery

    Measured: Depending on post operative recovery(2 days-2 months)

  2. Time to ambulate

    This parameter depending on lots of factors( eg; physiotherapy, weight, attitudes, other medical conditions ect...)

    Measured: 1 week to 2 months

  3. Perioperative Complications

    Post operative complications include ICU admissions, hypoxia, re-intubation, Myocardial Infarctions, Wound Infections, Deep Vein Thrombosis, Pneumonia, Sepsis, Urinary Tract Infection, Stroke, etc..)

    Measured: 10-14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2016 (estimated)
  2. Study start24 Mar 2016
  3. Primary completion30 Apr 2021
  4. Study completion30 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02954224
Sponsor's protocol ID
2014-0122-B
Acronym
PODESA
Status last verified
Oct 2022
First submitted
23 Sep 2016
Last updated
2 Nov 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Wong J, Doherty HR, Singh M, Choi S, Siddiqui N, Lam D, Liyanage N, Tomlinson G, Chung F. The prevention of delirium in elderly surgical patients with obstructive sleep apnea (PODESA): a randomized controlled trial. BMC Anesthesiol. 2022 Sep 14;22(1):290. doi: 10.1186/s12871-022-01831-1.

    PubMed 36104664

  • Wong J, Lam D, Choi S, Singh M, Siddiqui N, Sockalingam S, Chung F. The prevention of delirium in elderly with obstructive sleep apnea (PODESA) study: protocol for a multi-centre prospective randomized, controlled trial. BMC Anesthesiol. 2018 Jan 3;18(1):1. doi: 10.1186/s12871-017-0465-5.

    PubMed 29298664

Questions about this trial

What is this clinical trial studying?

A study testing CPAP treatment in people with Sleep Apnea, run by University Health Network, Toronto at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative delirium (time frame: 2 MONTHS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02954224, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.

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