CPAP for Obstructive Sleep Apnea

(T1D and OSA Trial)

Overseen By Becky Tucker

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must be taking: Insulin

Must not be taking: Glucocorticoids, Antipsychotics, Thiazides, others

Disqualifiers: Severe hypoglycemia, Proliferative retinopathy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sleep apnea, a condition where breathing stops and starts during sleep, affects blood sugar control in adults with Type 1 diabetes. Participants will either receive CPAP treatment, which helps keep airways open during sleep, or no treatment for their sleep apnea. The trial targets adults aged 18 to 50 who have Type 1 diabetes, use an insulin pump, and have been diagnosed with moderate to severe sleep apnea. As an unphased trial, it offers participants the chance to contribute to understanding the impact of sleep apnea treatment on diabetes management.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that can affect metabolic assessments, such as systemic glucocorticoids, antipsychotics, thiazide diuretics, beta-blockers, and some others. If you're on any of these, you may need to stop them to participate.

What prior data suggests that this CPAP treatment is safe for adults with Type 1 diabetes?

Research has shown that CPAP (Continuous Positive Airway Pressure) treatment is generally safe for people with obstructive sleep apnea. Studies indicate that using CPAP can improve quality of life and may reduce the risk of heart problems and death. For instance, one study found that people using CPAP had fewer heart-related issues. Another study discovered that it also helped people feel less sleepy during the day. These findings suggest that CPAP is well-tolerated and offers significant benefits for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Continuous Positive Airway Pressure (CPAP) for obstructive sleep apnea (OSA) because it offers a non-invasive way to keep airways open during sleep. Most treatments for OSA, like lifestyle changes and surgical options, can be invasive or require significant lifestyle adjustments. CPAP stands out because it uses a gentle, steady stream of air to prevent airway collapse, making it an effective, immediate solution that can significantly improve sleep quality and reduce daytime sleepiness. This approach directly addresses the root cause of OSA, providing relief without the need for surgery or long-term medications.

What evidence suggests that CPAP is effective for obstructive sleep apnea?

Research has shown that continuous positive airway pressure (CPAP) can greatly improve the quality of life for people with severe and moderate obstructive sleep apnea (OSA). In this trial, participants will either receive CPAP treatment or remain untreated. Using CPAP for at least four hours each night is linked to a lower risk of death. It keeps airways open during sleep, reducing snoring and aiding breathing. Over time, CPAP effectively manages OSA, but symptoms like snoring might return if treatment stops for several years. The success of CPAP in treating OSA suggests it might also help control blood sugar levels in people with Type 1 diabetes. ^{1 6 7 8}

Who Is on the Research Team?

Esra Tasali, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

Adults with Type 1 Diabetes for 3-20 years, using insulin pumps and CGM devices, who also have moderate to severe Obstructive Sleep Apnea as confirmed by a home sleep test. They should have a glucose management indicator of 5.5% to 8.5% and normal hemoglobin levels.

Inclusion Criteria

I have Type 1 Diabetes for 3-20 years, use an insulin pump and CGM, and my GMI is between 5.5% and 8.5%.

I have moderate to severe sleep apnea diagnosed by a home test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CPAP treatment for obstructive sleep apnea

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous positive airway pressure (CPAP)

Trial Overview The trial is studying the use of Continuous Positive Airway Pressure (CPAP) therapy on adults with Type 1 Diabetes who suffer from Obstructive Sleep Apnea, to see if it improves blood sugar control.

How Is the Trial Designed?

Group I: Untreated Active Control 1 Intervention

No treatment for OSA

Group II: Treated: Continuous positive airway pressure (CPAP) treatment Active Control 1 Intervention

Treatment for OSA by CPAP

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5436801/

IMPACT OF CONTINOUS POSITIVE AIRWAY PRESSURE ... We found that long-term improvement in quality of life occurs with the use of CPAP in persons with severe and possibly moderate sleep apnea.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590041224000151

Continuous positive airway pressure treatment for ... In the first year following CPAP initiation, OSA patients were more likely to be hospitalized than controls, but the primary diagnoses were remarkably different ...

3. cjrt.ca cjrt.ca/article/92080-positive-airway-pressure-therapy-adherence-and-outcomes-in-obstructive-sleep-apnea-an-exploratory-longitudinal-retrospective-randomized-chart-review

Positive airway pressure therapy adherence and outcomes ... Observational studies have found a significant reduction in mortality with four or more hours per night of PAP therapy compared to no usage9–12; ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39407808/

Effectiveness of Treating Obstructive Sleep Apnea by ... Surgical interventions and CPAP therapy showed potential long-term effectiveness in managing OSA. Snoring symptoms reappeared about 3.9-5.3 years after ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823539

Positive Airway Pressure, Mortality, and CV Risk in Older ... In this cohort study of Medicare beneficiaries with OSA, PAP utilization was associated with lower all-cause mortality and MACE incidence.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1389945724001096

Real-world impact of continuous positive airway pressure ... After starting CPAP treatment, the overall median (IQR) ESS score decreased (improved) by 2 (6) points from baseline to follow-up, and mean ESS scores decreased ...

7. 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 ...

8. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(24)00087-2/fulltext

May continuous positive airway pressure (CPAP) treatment ... CPAP treatment would reduce this risk by correcting the hypoxic burden and sleep fragmentation. However, randomized controlled trials failed to ...