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Early Management Strategy for Obstructive Sleep Apnea
N/A
Recruiting
Led By Sachin Pendharkar
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week after sleep physician visit
Awards & highlights
Study Summary
This trialwill assess the effect of quicker care for OSA on acceptance of treatment, patient satisfaction, sleepiness and quality of life.
Who is the study for?
This trial is for individuals with obstructive sleep apnea who have moderate sleepiness and haven't been hospitalized recently for unstable heart/lung conditions, don't have upcoming major surgery, no recent car accidents, not on multiple blood pressure meds, not in a safety-critical job, without other severe sleep issues or extreme daytime sleepiness, and no prior OSA treatment.Check my eligibility
What is being tested?
The study tests if getting care quickly after an obstructive sleep apnea diagnosis improves sticking to positive airway pressure therapy at three months. It also looks at whether this early management betters patient's reported sleepiness, quality of life and satisfaction compared to usual care.See study design
What are the potential side effects?
While the trial itself doesn’t involve medication that would cause side effects typically associated with drugs, using positive airway pressure therapy can sometimes lead to discomfort like dry mouth/nose or mask-related irritation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week after sleep physician visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week after sleep physician visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Positive airway pressure adherence
Secondary outcome measures
Adherent to positive airway pressure
Disease-specific health-related quality of life: Change in Sleep Apnea Quality of Life Index
General health-related quality of life: Change in EuroQoL-5D-3L
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Early ManagementExperimental Treatment1 Intervention
Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage
Group II: Usual CareActive Control1 Intervention
Scheduled for sleep physician appointment approximately 6 months after home sleep apnea test/triage
Find a Location
Who is running the clinical trial?
University of CalgaryLead Sponsor
792 Previous Clinical Trials
868,984 Total Patients Enrolled
Canadian Lung AssociationIndustry Sponsor
9 Previous Clinical Trials
65,495 Total Patients Enrolled
Sachin PendharkarPrincipal InvestigatorUniversity of Calgary
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated for sleep apnea before.Your sleep test result shows that you have moderate sleep apnea and you experience mild to moderate daytime sleepiness.I was hospitalized for heart or lung problems in the last 30 days.You were in a car accident within the past year.I do not have severe sleep disorders like insomnia or restless leg syndrome.You have a high number of breathing events while sleeping and you score between 10 and 15 on the Epworth Sleepiness Scale.I need three or more medications to control my high blood pressure.I am scheduled for a major surgery within the next six months.I often feel very sleepy during the day.Your oxygen levels drop very low while sleeping.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: Early Management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts still ongoing for this experiment?
"According to clinicaltrials.gov, this trial is not currently accepting new patients; it was first posted on June 24th 2022 and last updated November 2nd 2022. Nevertheless, 291 other medical trials are actively recruiting participants at the moment."
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