Personalized Treatment for Obstructive Sleep Apnea
(PRAISE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Miami
Disqualifiers: Progressive illnesses, Cognitive impairment, others
No Placebo Group
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this research is to see how effective the Personalized obstructive sleep apnea (OSA) Treatment Adherence Model called PRAISE is in helping the patient stick to the physician recommended OSA treatment plan Positive Airway Pressure (PAP).
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Personalized Obstructive Sleep Apnea Treatment?
Research shows that bilevel positive airway pressure (BPAP) can be an effective alternative for patients with obstructive sleep apnea (OSA) who do not respond well to continuous positive airway pressure (CPAP). BPAP may improve treatment adherence and outcomes, especially in patients who struggle with CPAP, by providing a more comfortable and adjustable pressure support.
12345Is personalized treatment for obstructive sleep apnea safe for humans?
Positive airway pressure therapies, including CPAP and bilevel PAP, have been used for decades to treat obstructive sleep apnea and are generally considered safe for humans. Some people may experience issues with comfort or side effects, but different modes of therapy can help alleviate these problems.
13467How is Personalized OSA Treatment different from other treatments for obstructive sleep apnea?
Personalized OSA Treatment is unique because it tailors the therapy to the individual's specific needs, using advanced technology to adjust the pressure levels automatically based on the patient's breathing patterns. This personalized approach aims to improve treatment effectiveness and patient comfort compared to standard treatments like fixed-pressure CPAP.
1891011Eligibility Criteria
This trial is for African American, African, Caribbean or black individuals aged 60-85 with obstructive sleep apnea (OSA). Participants must be reachable by phone and give consent to release medical data. It's not for those planning to move soon, with terminal illnesses, or cognitive impairments that prevent participation.Inclusion Criteria
Consent, including permission to release medical data
I am between 60 and 85 years old.
I have been diagnosed with obstructive sleep apnea.
+2 more
Exclusion Criteria
I am mentally and physically able to participate in the study.
Family member currently enrolled
You plan to move to a new place within the next year.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive personalized or standard of care OSA treatment for sleep apnea
6 months
Follow-up
Participants are monitored for changes in various biomarkers and cognitive functions
6 months
Participant Groups
The study tests the PRAISE model's effectiveness in improving adherence to Positive Airway Pressure (PAP) treatment for OSA. It compares standard care against a personalized approach to see if it can better manage OSA and impact Alzheimer’s disease biomarkers and cognition.
2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized OSA Treatment GroupExperimental Treatment2 Interventions
Participants in this group receive personalized OSA treatment for sleep apnea for up to six months.
Group II: Standard of Care GroupActive Control1 Intervention
Participants in this group receive the standard of care treatment for sleep apnea for up to six months.
Personalized OSA Treatment is already approved in United States, European Union, Canada, Japan, Australia for the following indications:
🇺🇸 Approved in United States as PAP Therapy for:
- Obstructive Sleep Apnea
🇪🇺 Approved in European Union as PAP Therapy for:
- Obstructive Sleep Apnea
🇨🇦 Approved in Canada as PAP Therapy for:
- Obstructive Sleep Apnea
🇯🇵 Approved in Japan as PAP Therapy for:
- Obstructive Sleep Apnea
🇦🇺 Approved in Australia as PAP Therapy for:
- Obstructive Sleep Apnea
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
University of MiamiLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Positive Airway Pressure Device Technology Past and Present: What's in the "Black Box"? [2018]Since the introduction of continuous positive airway pressure (PAP) for the treatment of obstructive sleep apnea (OSA) in 1981, PAP technology has diversified exponentially. Compact and quiet fixed continuous PAP flow generators, autotitrating PAP devices, and bilevel PAP devices that can treat multiple sleep-disordered breathing phenotypes including OSA, central sleep apnea (CSA), combinations of OSA and CSA, and hypoventilation are available. Adaptive servo-ventilators can suppress Hunter-Cheyne-Stokes breathing and CSA and treat coexisting obstructive events. Volume-assured pressure support PAP apparatus purports to provide a targeted degree of ventilatory assistance while also treating cooccurring OSA and/or CSA.
BPAP is an effective second-line therapy for obese patients with OSA failing regular CPAP: A prospective observational cohort study. [2021]Continuous positive airway pressure (CPAP) is the most common treatment for obstructive sleep apnoea (OSA), but many patients fail long-term therapy. Bilevel positive airway pressure (BPAP) is a potential alternative. We hypothesized that BPAP could improve treatment adherence and outcomes in patients who cannot tolerate CPAP.
Bilevel positive airway pressure for obstructive sleep apnea. [2014]For most patients with obstructive sleep apnea syndrome (OSA), continuous positive airway pressure (CPAP) is an effective therapy. However, for a subset of individuals, CPAP is either not effective or is poorly tolerated. Bilevel positive airway pressure (BPAP) is potentially capable of treating OSA at a lower mean pressure than CPAP and can help augment ventilation via pressure support. This review summarizes the evidence for the use of BPAP in spontaneous mode in the initial treatment of patients with OSA and in those who are poorly compliant with CPAP therapy. It also examines evidence regarding use of BPAP in OSA with associated hypoventilation, such as in chronic obstructive pulmonary disease or severe obesity. Finally, current clinical guidelines that help determine which patients would be candidates for a BPAP device and how to manually titrate BPAP to determine the optimal settings to be prescribed are also discussed.
Sleep-Related Breathing Disorders: When CPAP Is Not Enough. [2022]Three decades ago, continuous positive airway pressure (CPAP) was introduced to treat obstructive sleep apnea (OSA). Shortly after, bilevel positive airway pressure devices (BPAP) that independently adjusted inspiratory and expiratory positive airway pressure were developed to treat complex sleep-related breathing disorders unresponsive to CPAP. Based on the bilevel positive airway pressure platform (hardware) governed by propriety algorithms (software), advanced modes of noninvasive ventilation (NIV) were developed to address complex cardiorespiratory pathophysiology beyond OSA. This review summarizes key aspects of different bilevel PAP therapies (BPAP with/without backup rate, adaptive servoventilation, and volume-assured pressure support) to treat common sleep-related hypoventilation disorders, treatment-emergent central sleep apnea, and central sleep apnea syndromes.
Positive pressure therapy. [2019]Positive airway pressure in the treatment of obstructive sleep-disordered breathing (OSDB) is reviewed. Continuous positive airway pressure (CPAP), bilevel positive airway pressure, and variable (auto-CPAP) pressure, their mechanisms of action, benefits, and complications are examined. A perspective on the future of positive airway pressure therapy for OSDB is provided.
A randomized, double-blind clinical trial comparing continuous positive airway pressure with a novel bilevel pressure system for treatment of obstructive sleep apnea syndrome. [2022]To obtain efficacy, objective compliance, and self-assessment data from obstructive sleep apnea syndrome (OSAS) patients treated with continuous positive airway pressure (CPAP) or a novel bilevel (NBL) therapy.
Effect of switching from continuous to bilevel positive airway pressure on sleep quality in patients with obstructive sleep apnea: the prospective POP IN VAuto study. [2023]Label="Background" NlmCategory="UNASSIGNED">Issues with tolerability and side effects can decrease continuous positive airway pressure (CPAP) device usage and the benefits of therapy. Different positive airway pressure (PAP) therapy modes providing expiratory pressure relief or using a different pressure during inspiration vs. expiration (bilevel PAP) may alleviate some of these issues. This multicenter, prospective study evaluated the effects of switching from CPAP to bilevel PAP (VAuto mode) on respiratory parameters, device usage, side effects and patient-reported outcomes in patients with obstructive sleep apnea (OSA).
[Efficacy of demand of positive airway pressure therapy for treating obstructive sleep apnea syndrome]. [2018]The treatment of choice for obstructive sleep apnea syndrome (OSAS) is nasal continuous positive airway pressure (nCPAP). The precise level of pressure is adjusted by polysomnography. Devices to deliver pressure on demand have recently been designed to adapt the level of pressure to each respiratory cycle according to flow modification.
From CPAP to tailored therapy for obstructive sleep Apnoea. [2020]Obstructive Sleep Apnoea (OSA) is a common sleep disorder that is associated with daytime symptoms and a range of comorbidity and mortality. Continuous Positive Airway Pressure (CPAP) therapy is highly efficacious at preventing OSA when in use and has long been the standard treatment for newly diagnosed patients. However, CPAP therapy has well recognised limitations in real world effectiveness due to issues with patient acceptance and suboptimal usage. There is a clear need to enhance OSA treatment strategies and options. Although there are a range of alternative treatments (e.g. weight loss, oral appliances, positional devices, surgery, and emerging therapies such as sedatives and oxygen), generally there are individual differences in efficacy and often OSA will not be completely eliminated. There is increasing recognition that OSA is a heterogeneous disorder in terms of risk factors, clinical presentation, pathophysiology and comorbidity. Better characterisation of OSA heterogeneity will enable tailored approaches to therapy to ensure treatment effectiveness. Tools to elucidate individual anatomical and pathophysiological phenotypes in clinical practice are receiving attention. Additionally, recognising patient preferences, treatment enhancement strategies and broader assessment of treatment effectiveness are part of tailoring therapy at the individual level. This review provides a narrative of current treatment approaches and limitations and the future potential for individual tailoring to enhance treatment effectiveness.
Treatment of obstructive sleep apnea syndrome. [2010]Several treatment options are available for obstructive sleep apnea syndrome (OSAS), including various types of positive airway pressure (PAP) therapy, oral appliances, surgery, and conservative approaches including weight loss and positional therapy. This article focuses on continuous positive airway pressure treatment and technological advancements in the delivery of PAP therapy for OSAS, reviews indications for treatment, treatment outcomes, and methods of improving compliance, and discusses the other non-PAP treatment options.
Personalized Medicine for Obstructive Sleep Apnea Therapies: Are We There Yet? [2017]Currently there is no method to predict which treatments for obstructive sleep apnea will have the best outcomes in individual patients. Given that there is increasing interest in a personalized medicine approach to the treatment of a variety of disorders, this review describes the personalized approaches that are currently available for the treatment of obstructive sleep apnea as well as future directions for individualized obstructive sleep apnea treatment.