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

170 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to evaluate the effect of more timely care for obstructive sleep apnea (OSA) on adherence to positive airway pressure (PAP) therapy at three months after treatment initiation. The secondary objectives are to determine if earlier care improves the treatment effect of PAP on patient reported sleepiness, quality of life and patient satisfaction. We will also evaluate the impact of shorter wait times on patient engagement in therapy by assessing initial acceptance of PAP therapy, patient activation and self-efficacy with respect to OSA treatment. The study hypothesis is that the early management strategy will be superior to usual care with respect to the primary outcome of PAP adherence at three months.

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 data supports the effectiveness of the treatment Early Management for obstructive sleep apnea?

Research shows that continuous positive airway pressure (CPAP), a common treatment for obstructive sleep apnea, significantly improves sleep quality and oxygen levels in patients. This suggests that similar treatments focusing on airway management can be effective in managing obstructive sleep apnea. ^{1 2 3 4 5}

Is the early management strategy for obstructive sleep apnea safe for humans?

Surgery for obstructive sleep apnea has been studied for safety, but the results are not clearly established. Some treatments like CPAP (a machine that helps keep your airway open) are widely used and generally safe, though they can cause minor issues like nasal congestion or mask discomfort. ^{6 7 8 9 10}

How does the Early Management treatment for obstructive sleep apnea differ from other treatments?

The Early Management treatment for obstructive sleep apnea may focus on early intervention strategies that differ from standard treatments like continuous positive airway pressure (CPAP), which is the first-line therapy for severe cases. This approach might include lifestyle modifications, patient education, and possibly new minimally invasive techniques, aiming for a more holistic and patient-centered management of the condition. ^{3 11 12 13 14}

Research Team

Sachin Pendharkar

Principal Investigator

University of Calgary

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparing methods of respiratory event detection during the treatment of obstructive sleep apnea. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Management of obstructive sleep apnea. [2005]

3. Italy pubmed.ncbi.nlm.nih.gov

Continuous positive airway pressure improves the quality of sleep and oxygenation in obstructive sleep apnea syndrome. [2019]

4. Ireland pubmed.ncbi.nlm.nih.gov

Risk factors analysis and intervention of lung dysfunction in children with obstructive sleep apnea: A retrospective case series study. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Nasal continuous positive airway pressure use in children with obstructive sleep apnea younger than 2 years of age. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety of outpatient surgery for obstructive sleep apnea. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Effects and side-effects of surgery for snoring and obstructive sleep apnea--a systematic review. [2022]

8. England pubmed.ncbi.nlm.nih.gov

An algorithm for the sedation of patients with obstructive sleep apnea by non-anesthesiologists. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Reporting results of obstructive sleep apnea syndrome surgery trials. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnea. Warding off the sometimes dire consequences. [2005]

12. England pubmed.ncbi.nlm.nih.gov

Obstructive sleep apnoea in adults. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Management of obstructive sleep apnea by continuous positive airway pressure. [2021]

14. China pubmed.ncbi.nlm.nih.gov

When continuous positive airway pressure (CPAP) fails. [2022]