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Early Management Strategy for Obstructive Sleep Apnea

N/A
Waitlist Available
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
Must not have
Significant co-morbid sleep disorder that would interfere with PAP acclimatization and adherence (e.g., severe insomnia, restless leg syndrome)
Severe hypertension requiring ≥ three antihypertensive medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week after sleep physician visit
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe sleep disorders like insomnia or restless leg syndrome.
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I need three or more medications to control my high blood pressure.
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I often feel very sleepy during the day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week after sleep physician visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week after sleep physician visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Positive airway pressure adherence
Secondary study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
808 Previous Clinical Trials
884,219 Total Patients Enrolled
Canadian Lung AssociationIndustry Sponsor
9 Previous Clinical Trials
65,495 Total Patients Enrolled
Sachin PendharkarPrincipal InvestigatorUniversity of Calgary

Media Library

Early Management Clinical Trial Eligibility Overview. Trial Name: NCT04613414 — N/A
Obstructive Sleep Apnea Research Study Groups: Usual Care, Early Management
Obstructive Sleep Apnea Clinical Trial 2023: Early Management Highlights & Side Effects. Trial Name: NCT04613414 — N/A
Early Management 2023 Treatment Timeline for Medical Study. Trial Name: NCT04613414 — N/A
~6 spots leftby Dec 2024
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