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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 belowSelect...
I am prediabetic.
Select...
I have been diagnosed with sleep apnea.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of bleeding disorders.
Select...
I have diabetes.
Select...
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
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)
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?
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?
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Who is running the clinical trial?
University of ChicagoLead Sponsor
1,057 Previous Clinical Trials
763,331 Total Patients Enrolled
2 Trials studying Sleep Apnea
213 Patients Enrolled for Sleep Apnea
Mayo ClinicOTHER
3,350 Previous Clinical Trials
3,060,374 Total Patients Enrolled
4 Trials studying Sleep Apnea
1,479 Patients Enrolled for Sleep Apnea
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,938 Previous Clinical Trials
47,791,998 Total Patients Enrolled
15 Trials studying Sleep Apnea
5,258 Patients Enrolled for Sleep Apnea
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on medications that could affect test results.I am overweight or obese.I am prediabetic.I have a history of bleeding disorders.I have diabetes.You have a medical condition that may shorten your life or make treatment risky.I have very high blood pressure.I have been diagnosed with sleep apnea.
Research Study Groups:
This trial has the following groups:- Group 1: Niacin
- Group 2: Continuous positive airway pressure (CPAP) treatment
- Group 3: Untreated
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Sleep Apnea Patient Testimony for trial: Trial Name: NCT04234217 — N/A
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