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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment CPAP + Niacin for Sleep Apnea and Prediabetes?

Research shows that non-invasive positive pressure ventilation (NIPPV), similar to CPAP, is effective in improving breathing and avoiding more invasive procedures in people with respiratory issues. This suggests that CPAP could help manage sleep apnea by improving airflow during sleep. ^{1 2 3 4 5}

Is CPAP or Niacin safe for humans?

CPAP (Continuous Positive Airway Pressure) and similar non-invasive ventilation methods are generally considered safe for treating breathing problems, as they help avoid more invasive procedures like intubation. However, specific safety data for using CPAP combined with Niacin (Vitamin B3) for sleep apnea and prediabetes is not available in the provided research. ^{2 6 7 8 9}

How does the CPAP treatment for sleep apnea and prediabetes differ from other treatments?

CPAP (Continuous Positive Airway Pressure) is unique because it provides a steady stream of air through a mask to keep airways open during sleep, which is different from medications or surgeries that might be used for sleep apnea. This treatment is non-invasive and can be used at home, making it more convenient for long-term management compared to more invasive procedures. ^{1 2 6 10 11}

Research Team

Esra Tasali, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

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

Nocturnal non-invasive ventilation for cardio-respiratory disorders in adults. [2013]

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

Noninvasive ventilation in respiratory failure due to cystic fibrosis. [2005]

3. France pubmed.ncbi.nlm.nih.gov

Efficacy of preoxygenation with non-invasive low positive pressure ventilation in obese patients: crossover physiological study. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Systematic review of non-invasive positive pressure ventilation for chronic respiratory failure. [2018]

5. Australia pubmed.ncbi.nlm.nih.gov

Non-invasive ventilation in the management of respiratory failure. [2019]

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

Pre-hospital non-invasive ventilation for acute respiratory failure: a systematic review and cost-effectiveness evaluation. [2022]

7. Iran pubmed.ncbi.nlm.nih.gov

Noninvasive positive pressure ventilation or conventional mechanical ventilation for neonatal continuous positive airway pressure failure. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Early predictors of success of non-invasive positive pressure ventilation in hypercapnic respiratory failure. [2020]

9. Norway 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. [2019]

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

Nasal ventilation to facilitate weaning in patients with chronic respiratory insufficiency. [2019]

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

Nocturnal non-invasive positive pressure ventilation for stable chronic obstructive pulmonary disease. [2022]