CPAP + Niacin for Sleep Apnea and Prediabetes

Overseen By Becky Tucker, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Confounding medications

Disqualifiers: Diabetes, Severe hypertension, Bleeding disorders, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 months

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sleep apnea might lead to diabetes. Researchers are examining the effects of CPAP (a machine that aids breathing during sleep) and niacin (a vitamin that affects fat breakdown) on individuals with sleep apnea and prediabetes. Participants will join one of three groups: CPAP, niacin, or no treatment. This trial suits those who are overweight, have prediabetes, and struggle with sleep apnea. As an unphased trial, it offers a unique opportunity to contribute to understanding the link between sleep apnea and diabetes.

Will I have to stop taking my current medications?

The trial excludes people taking medications that can interfere with the study's assessments, so you might need to stop some medications. However, the protocol does not specify which medications are included.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both niacin and continuous positive airway pressure (CPAP) have important safety information. Niacin, a type of vitamin B3, is generally safe in normal amounts, but high doses can cause side effects like skin flushing, headaches, and dizziness. In rare cases, it might affect the liver.

CPAP, a common treatment for sleep apnea, has been shown to improve the quality of life for people with moderate to severe sleep apnea. However, some users may still feel sleepy during the day, even with treatment.

Both niacin and CPAP have known side effects, but they are generally well-tolerated. Considering these potential effects is important when deciding whether to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining CPAP and niacin for sleep apnea and prediabetes because it targets both airway obstruction and metabolic processes. Unlike standard treatments that primarily focus on keeping airways open, this approach also uses niacin to suppress lipolysis, potentially improving metabolic health. This dual-action strategy could offer a more comprehensive solution for individuals facing both sleep and metabolic issues.

What evidence suggests that this trial's treatments could be effective for sleep apnea and prediabetes?

Research has shown that using a continuous positive airway pressure (CPAP) machine, which participants in this trial may receive, can improve how the body processes sugar in people with prediabetes. One study found that using CPAP for 8 hours each night improved sugar control in just two weeks. Over five years, regular CPAP use has also been linked to lower blood pressure and better blood sugar levels. Another treatment option in this trial is niacin, known to affect how the body handles fats and potentially help manage prediabetes. Both treatments offer potential benefits, but stronger evidence supports the effectiveness of CPAP. ^{6 7 8 9 10}

Who Is on the Research Team?

Esra Tasali, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am overweight or obese.

I am prediabetic.

I have been diagnosed with sleep apnea.

Exclusion Criteria

I am not on medications that could affect test results.

I have a history of bleeding disorders.

I have diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo three in-laboratory conditions: untreated obstructive sleep apnea, CPAP treatment, and untreated with pharmacologically suppressed lipolysis using Niacin

4 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
• Niacin

Trial Overview 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.

How Is the Trial Designed?

Group I: Niacin Active Control 1 Intervention

Untreated, pharmacological suppression of lipolysis by Niacin

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

Continuous positive airway pressure (CPAP) treatment

Group III: Untreated Active Control 1 Intervention

Untreated condition (obstructive sleep apnea)

Continuous positive airway pressure is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as CPAP for:

• Obstructive sleep apnea
• Respiratory failure
• Congestive heart failure
• Chronic obstructive pulmonary disease (COPD)
• Pneumonia

Approved in United States as CPAP for:

• Obstructive sleep apnea
• Respiratory failure
• Congestive heart failure
• Chronic obstructive pulmonary disease (COPD)
• Pneumonia
• Acute bronchitis

Approved in Canada as CPAP for:

• Obstructive sleep apnea
• Respiratory failure
• Congestive heart failure
• Chronic obstructive pulmonary disease (COPD)
• Pneumonia

Approved in Japan as CPAP for:

• Obstructive sleep apnea
• Respiratory failure
• Congestive heart failure
• Chronic obstructive pulmonary disease (COPD)
• Pneumonia

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

AdventHealth

Collaborator

Trials

118

Recruited

31,800+

Published Research Related to This Trial

Non-invasive positive pressure ventilation (NIPPV) is increasingly used for both acute and chronic respiratory issues, particularly during sleep, as it helps avoid more invasive procedures like intubation, which can have serious complications.

This review highlights the importance of understanding the proper methodologies for using nocturnal NIPPV in treating conditions such as congestive heart failure, COPD, and obesity hypoventilation syndrome, emphasizing its role in improving patient outcomes in these disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nocturnal non-invasive ventilation for cardio-respiratory disorders in adults. Wahab, R., Basner, RC.[2013]

In a retrospective review of five cystic fibrosis patients, noninvasive positive-pressure ventilation (NIPPV) effectively treated respiratory failure without the need for endotracheal intubation, demonstrating its safety and efficacy in this population.

NIPPV led to significant improvements in respiratory rates, oxygen saturation, and carbon dioxide levels, indicating its role in managing acute pulmonary exacerbations and preventing further respiratory decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive ventilation in respiratory failure due to cystic fibrosis. Sprague, K., Graff, G., Tobias, DJ.[2005]

Non-invasive positive pressure ventilation (NIPPV) significantly improves patient-reported outcomes such as somnolence, fatigue, and sleep quality in individuals with chronic respiratory failure, particularly in conditions like ALS/MND and obesity hypoventilation syndrome (OHS).

Patients with ALS/MND also experience prolonged survival with NIPPV, while the effects on Duchenne muscular dystrophy (DMD) remain inconclusive, indicating that the benefits of NIPPV vary based on the underlying respiratory condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of non-invasive positive pressure ventilation for chronic respiratory failure. Hannan, LM., Dominelli, GS., Chen, YW., et al.[2018]

Pre-hospital continuous positive airway pressure (CPAP) significantly reduces mortality and intubation rates in adults with acute respiratory failure compared to standard care, based on a meta-analysis of 10 studies involving 650 patients.

While pre-hospital CPAP is more effective, it is also more expensive, with an incremental cost-effectiveness ratio of £20,514 per quality-adjusted life-year (QALY), indicating that its cost-effectiveness remains uncertain and warrants further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-hospital non-invasive ventilation for acute respiratory failure: a systematic review and cost-effectiveness evaluation. Pandor, A., Thokala, P., Goodacre, S., et al.[2022]

Nasal intermittent positive pressure ventilation (NIPPV), specifically synchronized NIPPV (SNIPPV), significantly reduces the rate of extubation failure in preterm infants compared to nasal continuous positive airway pressure (NCPAP), with a relative risk of 0.21 and a number needed to treat of 3.

While NIPPV shows promise in reducing the frequency of apnoea of prematurity, further research is needed to fully understand its effectiveness in this area, as current studies indicate a trend favoring NIPPV but do not provide conclusive meta-analysis results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal continuous positive airway pressure versus nasal intermittent positive pressure ventilation for preterm neonates: a systematic review and meta-analysis. De Paoli, AG., Davis, PG., Lemyre, B.[2019]

Non-invasive positive pressure ventilation (NIPPV) is increasingly recognized for its effectiveness in treating respiratory failure, improving gas exchange, and reducing the need for intubation, which can lead to lower mortality rates.

Recent developments and recommendations highlight the importance of proper methodology in applying NIPPV, emphasizing its role in both acute and chronic respiratory failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive ventilation in the management of respiratory failure. Chan, JK., Leung, RC., Lai, CK.[2019]

In a trial involving 22 patients with difficulties weaning off conventional ventilation, 18 successfully transitioned to nasal intermittent positive pressure ventilation (NIPPV), allowing them to be discharged home after a median of 11 days.

NIPPV not only helped facilitate spontaneous breathing but also reduced the need for intensive care, with 16 patients remaining well after discharge, and 10 continuing NIPPV at home, demonstrating its efficacy in managing chronic respiratory insufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal ventilation to facilitate weaning in patients with chronic respiratory insufficiency. Udwadia, ZF., Santis, GK., Steven, MH., et al.[2019]

A meta-analysis of seven studies involving 245 stable hypercapnic COPD patients found that nocturnal non-invasive positive pressure ventilation (NIPPV) did not show consistent significant improvements in key health measures such as gas exchange, exercise tolerance, or quality of life.

While the mean increase in six-minute walking distance (6MWD) was 27.7 meters, this change was not statistically significant, indicating that the true effect of NIPPV on exercise capacity remains uncertain, especially given the small sample sizes of the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nocturnal non-invasive positive pressure ventilation for stable chronic obstructive pulmonary disease. Struik, FM., Lacasse, Y., Goldstein, R., et al.[2022]

In a study of 55 preterm neonates with CPAP failure, 74% responded positively to nasal intermittent positive pressure ventilation (NIPPV), avoiding the need for intubation and mechanical ventilation.

NIPPV also resulted in a shorter duration of oxygen therapy (7.77 days) compared to conventional ventilation (9.28 days), suggesting it may be a more effective treatment option for these infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive positive pressure ventilation or conventional mechanical ventilation for neonatal continuous positive airway pressure failure. Badiee, Z., Nekooie, B., Mohammadizadeh, M.[2022]

In a study involving 30 obese patients, non-invasive positive pressure ventilation (NIPPV) improved the likelihood of achieving an expiratory O2 fraction (FeO2) of 90% or higher compared to tidal volume breathing (TVB), with 80% of patients reaching this level with NIPPV versus 60% with TVB.

While NIPPV did not significantly increase the overall FeO2 after 3 minutes compared to TVB, it resulted in a smaller tidal volume during preoxygenation, indicating that NIPPV can be beneficial for oxygenation in obese patients without compromising comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of preoxygenation with non-invasive low positive pressure ventilation in obese patients: crossover physiological study. Georgescu, M., Tanoubi, I., Fortier, LP., et al.[2013]

In a study of 100 patients with acute hypercapnic respiratory failure, 76% showed significant improvement in clinical parameters and arterial blood gas measurements after starting non-invasive positive pressure ventilation (NIPPV).

Improvement in heart rate, respiratory rate, pH, and PCO2 within the first hour of NIPPV treatment was a strong predictor of treatment success, while those who failed to respond often required intubation shortly after.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early predictors of success of non-invasive positive pressure ventilation in hypercapnic respiratory failure. Bhattacharyya, D., Prasad, B., Tampi, PS., et al.[2020]

Citations

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Eight Hours of Nightly Continuous Positive Airway ... In patients with prediabetes, 8-hour nightly CPAP treatment for 2 weeks improves glucose metabolism compared with placebo.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24705611/

Clinical outcomes and cost-effectiveness of continuous ... Results: Using CPAP was associated with significantly lower blood pressure at 5 years and increasingly lower HbA1c levels over 5 consecutive years compared with ...

3. diabetesjournals.org diabetesjournals.org/care/article/37/5/1263/38196/Clinical-Outcomes-and-Cost-effectiveness-of

Clinical Outcomes and Cost-effectiveness of Continuous ... Using CPAP was associated with significantly lower blood pressure at 5 years and increasingly lower HbA1c levels over 5 consecutive years compared with ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945719300048

Efficacy of continuous positive airway pressure (CPAP) ... The use of a CPAP device in addition to preventing apnea, hypopnea and snoring may improve insulin sensitivity, glucose metabolism, lipids, fat distribution and ...

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/486425

Type 2 Diabetes, Glycemic Control, and Continuous ... One study of 10 patients treated with CPAP for 4 months found an improvement in insulin responsiveness as measured by hyperinsulinemic euglycemic clamp analysis ...

6. 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.

7. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=204

Continuous Positive Airway Pressure (CPAP) Therapy for ... Coverage of CPAP is initially limited to a 12 week period for beneficiaries diagnosed with OSA as subsequently described.

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

May continuous positive airway pressure (CPAP) treatment ... May continuous positive airway pressure (CPAP) treatment be detrimental in obstructive sleep apnea?

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

Real-world impact of continuous positive airway pressure ... Excessive daytime sleepiness (EDS) persists in some patients with obstructive sleep apnea (OSA) despite continuous positive airway pressure (CPAP) treatment.

10. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/resp.13808

Clinical side effects of continuous positive airway pressure ... This review highlights the range of side effects associated with CPAP therapy in patients with OSA. This information is important for the initiation of ...