What side effects are associated with this type of intervention?

Common treatments for sleep apnea include pharmacologic agents like antimuscarinics (e.g., oxybutynin) and noradrenergic agents (e.g., atomoxetine), which can cause side effects such as dry mouth, constipation, urinary retention, and increased heart rate. Continuous Positive Airway Pressure (CPAP) therapy, another prevalent treatment, may lead to nasal congestion, dry mouth, and discomfort from the mask. Surgical interventions, though less common, can result in pain, swelling, and infection risks. Each treatment option has its own profile of potential adverse effects, and patients should discuss these with their healthcare provider to determine the best approach for their condition.

What prior FDA approvals exist?

FDA-approved treatments for sleep apnea include continuous positive airway pressure (CPAP), which is the most common and effective treatment. Pharmacotherapy options like modafinil and armodafinil are approved to manage residual excessive daytime sleepiness in OSA patients. Additionally, hypoglossal nerve stimulation is an FDA-approved treatment that helps maintain airway patency during sleep. These treatments focus on improving sleep quality and reducing intermittent hypoxia, which can positively impact glucose metabolism and insulin sensitivity.

What other types of research exist?

Promising novel alternatives to CPAP therapy for sleep apnea management in 2024 include nasal expiratory positive airway pressure (PAP), oral negative pressure devices, upper airway muscle stimulation, and bariatric surgery. These alternatives aim to improve sleep quality and reduce intermittent hypoxia, potentially enhancing glucose metabolism and insulin sensitivity.

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Device

CPAP + Niacin for Sleep Apnea and Prediabetes

N/A

Recruiting

Led By Esra Tasali, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prediabetic

Sleep apnea

Must not have

Any history of known bleeding disorders

Diabetic

Timeline

Screening 3 weeks

Treatment Varies

Follow Up niacin, within 4 months of screening

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how different treatments for sleep apnea affect blood sugar levels in patients with prediabetes. The goal is to see how these methods influence blood sugar control.

Who is the study for?

This trial is for individuals who are prediabetic, have sleep apnea, and are overweight or obese. It's not open to those with diabetes, severe high blood pressure, bleeding disorders, pregnant or nursing women, anyone with a life-limiting disease or on medications that could affect the study results.

What is being tested?

The study is testing whether Niacin (a vitamin) and Continuous Positive Airway Pressure (CPAP), which helps keep airways open during sleep, can prevent diabetes in people with sleep apnea.

What are the potential side effects?

Niacin may cause flushing of the skin, itching or rash; CPAP might lead to discomfort at the mask site, dry nose or throat. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am prediabetic.

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I have been diagnosed with sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of bleeding disorders.

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I have diabetes.

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I have very high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ niacin, within 4 months of screening

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~niacin, within 4 months of screening

This trial's timeline: 3 weeks for screening, Varies for treatment, and niacin, within 4 months of screening for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Plasma norepinephrine levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: NiacinActive Control1 Intervention

Untreated, pharmacological suppression of lipolysis by Niacin

Group II: Continuous positive airway pressure (CPAP) treatmentActive Control1 Intervention

Continuous positive airway pressure (CPAP) treatment

Group III: UntreatedActive Control1 Intervention

Untreated condition (obstructive sleep apnea)

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Sleep Apnea, such as Continuous Positive Airway Pressure (CPAP), work by maintaining open airways through a steady stream of air, preventing intermittent hypoxia and sleep fragmentation. This is vital for improving sleep quality and reducing metabolic dysfunctions like insulin resistance. Emerging therapies, including carbonic anhydrase inhibitors and neuromuscular training, aim to reduce airway collapsibility and stimulate respiratory drive, offering alternative options for patients who cannot tolerate CPAP. These treatments are important as they provide more personalized and potentially more effective management, enhancing overall health outcomes for Sleep Apnea patients.

Sleep apnea, metabolic disease, and the cutting edge of therapy.Obstructive sleep apnea and abnormal glucose metabolism.Is obstructive sleep apnea a risk factor for diabetes?