CPAP + Niacin for Sleep Apnea and Prediabetes
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Chicago
Must not be taking: Confounding medications
Disqualifiers: Diabetes, Severe hypertension, Bleeding disorders, others
No Placebo Group
Approved in 5 Jurisdictions
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.
12345Is 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.
36789How 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.
2391011Eligibility 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.
+3 more
Trial 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
Participant Groups
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.
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)
Continuous positive airway pressure is already approved in European Union, United States, Canada, Australia, 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 Australia 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of ChicagoChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
Mayo ClinicCollaborator
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
AdventHealthCollaborator
References
Efficacy of preoxygenation with non-invasive low positive pressure ventilation in obese patients: crossover physiological study. [2013]The impact of non-invasive positive pressure ventilation (NIPPV), which is a combination of inspiratory positive airway pressure (IPAP) and positive end expiratory pressure (PEEP), on the effectiveness of preoxygenation in obese patients was evaluated.
Nocturnal non-invasive ventilation for cardio-respiratory disorders in adults. [2013]Following the classic 'iron lung' non-invasive negative pressure ventilator, non-invasive positive pressure ventilation (NIPPV), particularly used 'nocturnally' has developed a broad role in both the acute hospital setting and domiciliary long-term use for many cardio-respiratory disorders associated with acute and chronic ventilatory failure. This role is based in part upon the perceived relative ease of application and discontinuation of NIPPV, ability to avoid intubation or tracheostomy and their associated morbidities and availability of increasingly portable pressure and volume cycled NIPPV devices. Nevertheless, the many methodologies necessary for optimal NIPPV use are often underappreciated by health care workers and patients alike. This review focuses on the rationale, practice, and future directions for 'nocturnal' use of non-invasive positive pressure ventilation (nNIV) in cardio-respiratory disorders in adults which are commonly associated with sleep-related apnea, hypoventilation and hypoxemia: congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), obesity hypoventilation syndrome (OHS), cystic fibrosis (CF) and neuromuscular disorders.
Noninvasive ventilation in respiratory failure due to cystic fibrosis. [2005]Noninvasive positive-pressure ventilation (NIPPV) is increasingly used as an effective means of avoiding endotracheal intubation and mechanical ventilation in patients with respiratory insufficiency or failure.
Systematic review of non-invasive positive pressure ventilation for chronic respiratory failure. [2018]This systematic review examined the effect of non-invasive positive pressure ventilation (NIPPV) on patient reported outcomes (PROs) and survival for individuals with or at risk of chronic respiratory failure (CRF).
Non-invasive ventilation in the management of respiratory failure. [2019]Non-invasive positive pressure ventilation (NIPPV) has been used increasingly to treat various forms of respiratory failure, with benefits in terms of gas exchange improvement, avoidance of endotracheal intubation and a decreased mortality. This review will focus on the recent developments and recommendations in the use of NIPPV in the treatment of acute and chronic respiratory failure, the methodology in the application of NIPPV, and briefly on its proposed mechanism of action.
Noninvasive positive pressure ventilation or conventional mechanical ventilation for neonatal continuous positive airway pressure failure. [2022]The aim of this study was to assess the success rate of nasal intermittent positive pressure ventilation (NIPPV) for treatment of continuous positive airway pressure (CPAP) failure and prevention of conventional ventilation (CV) in preterm neonates.
Early predictors of success of non-invasive positive pressure ventilation in hypercapnic respiratory failure. [2020]Non-invasive positive pressure ventilation (NIPPV) has emerged as a significant advancement in the management of acute hypercapnic respiratory failure.
Nasal continuous positive airway pressure versus nasal intermittent positive pressure ventilation for preterm neonates: a systematic review and meta-analysis. [2019]To determine whether nasal intermittent positive pressure ventilation (NIPPV) is more effective in preterm infants than nasal continuous positive airway pressure (NCPAP) in reducing the rate of extubation failure following mechanical ventilation, and reducing the frequency of apnoea of prematurity and subsequent need for endotracheal intubation.
Pre-hospital non-invasive ventilation for acute respiratory failure: a systematic review and cost-effectiveness evaluation. [2022]Non-invasive ventilation (NIV), in the form of continuous positive airway pressure (CPAP) or bilevel inspiratory positive airway pressure (BiPAP), is used in hospital to treat patients with acute respiratory failure. Pre-hospital NIV may be more effective than in-hospital NIV but requires additional ambulance service resources.
Nasal ventilation to facilitate weaning in patients with chronic respiratory insufficiency. [2019]The non-invasive technique of nasal intermittent positive pressure ventilation (NIPPV) has an established role in providing domiciliary nocturnal ventilatory support in patients with chest wall disorders, neuromuscular disease, and chronic obstructive lung disease. NIPPV was used to simplify ventilatory management and assist the return of spontaneous breathing in patients with chronic respiratory insufficiency who had failed to wean from conventional intermittent positive pressure ventilation (IPPV).
Nocturnal non-invasive positive pressure ventilation for stable chronic obstructive pulmonary disease. [2022]Non-invasive positive pressure ventilation (NIPPV) is effective in treating acute exacerbations of chronic obstructive pulmonary disease (COPD). Nocturnal non-invasive positive pressure ventilation (nocturnal-NIPPV) has been proposed as an intervention for stable hypercapnic patients with COPD.