Early Management Strategy for Obstructive Sleep Apnea

Overseen By Sachin Pendharkar

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Severe hypoxemia, Hypersomnolence, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether faster care for obstructive sleep apnea (OSA) improves adherence to breathing machines (PAP therapy) after three months. It also examines if quicker care reduces sleepiness, enhances quality of life, and increases satisfaction with treatment. The trial compares usual care, where patients see a doctor about six months after diagnosis, to early management, where they see a doctor within one month. Suitable participants have symptoms of OSA and have not yet received treatment. As an unphased trial, this study provides a unique opportunity to contribute to understanding the benefits of early intervention in OSA care.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have severe hypertension requiring three or more medications, you may not be eligible to participate.

What prior data suggests that this early management strategy is safe for obstructive sleep apnea?

Studies have shown that people with obstructive sleep apnea (OSA) may face a higher risk of certain health problems. Specifically, research indicates that individuals with OSA are more likely to experience breathing issues during surgery. However, these findings relate to OSA itself, not the safety of its treatments.

The trial focuses on "Early Management" of OSA, emphasizing the importance of consulting a sleep doctor sooner rather than later. This approach does not involve new drugs or devices; it centers on the timing and management of care. Since the trial does not introduce new or experimental treatments, there are no new safety concerns to report.

Typically, managing OSA includes using positive airway pressure (PAP) therapy, a well-known and widely used treatment. Research has shown that PAP therapy can improve long-term health outcomes for people with OSA. While any treatment can have potential side effects, PAP therapy is considered safe for most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores an early management strategy for obstructive sleep apnea (OSA), which could significantly improve patient outcomes compared to the usual care. Unlike the standard approach, where patients may wait up to six months for a follow-up after their initial sleep test, this early management strategy schedules a sleep physician appointment within just one month. This faster intervention can potentially lead to quicker diagnosis and treatment, possibly improving quality of life and reducing the risks associated with untreated OSA, such as cardiovascular issues and daytime fatigue. By testing this streamlined approach, researchers hope to demonstrate that early intervention can make a significant difference in managing OSA effectively.

What evidence suggests that this early management strategy is effective for obstructive sleep apnea?

Research has shown that starting treatment for obstructive sleep apnea (OSA) early can lead to better patient outcomes. In this trial, participants in the Early Management arm will see a sleep physician within one month of their home sleep apnea test/triage. Studies have found that receiving care sooner can improve adherence to positive airway pressure (PAP) therapy, a key treatment for OSA. PAP therapy reduces daytime sleepiness and enhances overall quality of life. Additionally, starting treatment earlier can increase patient satisfaction and engagement in their therapy. Evidence suggests that beginning treatment sooner leads to better health improvements and greater success in managing OSA symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Sachin Pendharkar

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Your sleep test result shows that you have moderate sleep apnea and you experience mild to moderate daytime sleepiness.

You have a high number of breathing events while sleeping and you score between 10 and 15 on the Epworth Sleepiness Scale.

Exclusion Criteria

I have been treated for sleep apnea before.

I was hospitalized for heart or lung problems in the last 30 days.

You were in a car accident within the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Management

Participants receive timely care for obstructive sleep apnea and are scheduled for a sleep physician appointment within 1 month of home sleep apnea test/triage

1 month

1 visit (in-person)

Usual Care

Participants are scheduled for a sleep physician appointment approximately 6 months after home sleep apnea test/triage

6 months

1 visit (in-person)

Follow-up

Participants are monitored for adherence to positive airway pressure therapy and other outcomes such as sleepiness, quality of life, and patient satisfaction

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Early Management

Trial Overview 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.

How Is the Trial Designed?

Group I: Early Management Experimental Treatment 1 Intervention

Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage

Group II: Usual Care Active Control 1 Intervention

Scheduled for sleep physician appointment approximately 6 months after home sleep apnea test/triage

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Canadian Lung Association

Industry Sponsor

Trials

10

Recruited

65,700+

Published Research Related to This Trial

In a study of 452 adult obstructive sleep apnea patients undergoing head and neck airway surgery, 89% of the surgeries were performed on an outpatient basis, which is contrary to existing guidelines.

The study found a zero catastrophic complication rate among ambulatory patients, indicating that such surgeries can be performed safely, although pain-related emergency room visits were common.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of outpatient surgery for obstructive sleep apnea. Baugh, R., Burke, B., Fink, B., et al.[2013]

Surgical procedures like laser-assisted uvulopalatoplasty and radiofrequency ablation show limited efficacy in improving daytime sleepiness, quality of life, and reducing the apnea-hypopnea index or snoring, based on a systematic review of four studies.

About half of the patients experienced persistent side effects from uvulopalatopharyngoplasty and uvulopalatoplasty, with common issues including difficulty swallowing and voice changes, highlighting the need for caution and further research into safer surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and side-effects of surgery for snoring and obstructive sleep apnea--a systematic review. Franklin, KA., Anttila, H., Axelsson, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12486363/

Obstructive Sleep Apnoea Treatments—Where Are We Now? Long‐term data on safety, adherence, and efficacy outcomes are therefore essential before incretins can be considered first‐line options or ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12547021/

Effect of sleep apnoea interventions on multiple health outcomes This umbrella review identified CPAP as the most effective intervention for reducing AHI and daytime sleepiness in patients with OSA, while ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0278239124006827

Comparing Treatment Effectiveness and Patient-Reported ... The primary outcome variable was efficacy defined as the therapeutic response to treatment measured using mean disease alleviation, a calculated variable ( ...

4. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.9750

Electronic health record–derived outcomes in obstructive ... An improvement in BP was noted within a year of CPAP therapy in newly diagnosed patients with OSA, with no difference in the magnitude of improvement.

5. mdpi.com mdpi.com/2077-0383/14/21/7586

Advancing Obstructive Sleep Apnea Management Data support liraglutide's efficacy in improving OSA severity alongside weight loss, with systematic reviews ... Presents Early Clinical Outcomes of the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7491676/

Outcomes and safety among patients with obstructive sleep ... The risk of post-operative death within 30 days was 0.02% higher in low or moderate OSA risk patients than in high risk or diagnosed OSA ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK459252/

Obstructive Sleep Apnea - StatPearls - NCBI Bookshelf Obstructive sleep apnea (OSA) is a sleep disorder characterized by repeated episodes of complete (apnea) or partial (hypopnea) collapse of the upper airway.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1087079224001333

Adverse events in patients with obstructive sleep apnea ... The odds of respiratory adverse events were significantly increased for patients with OSA (OR 1.65, 95 % CI 1.03–2.66, P = 0.04). Furthermore, the odds of ...

9. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10832

Long-term health outcomes for patients with obstructive sleep ... These authors reported a risk ratio of 0.43 (95% confidence interval: 0.30–0.63) for MVCs following CPAP therapy, similar to the overall point estimate. These ...

10. aasm.org aasm.org/resources/clinicalguidelines/osa_adults.pdf

Clinical Guideline for the Evaluation, Management and ... OSA should be approached as a chronic disease requiring long4term, multidisciplinary management. For each treat4 ment option, appropriate outcome measures and ...