330 Participants Needed

Personalized Treatment for Obstructive Sleep Apnea

(PRAISE Trial)

GJ
Overseen ByGirardin Jean-Louis, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Miami
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

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.12345

Is 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.13467

How 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.1891011

Research Team

GJ

Girardin Jean-Louis, PhD

Principal Investigator

University of Miami

Eligibility 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.
See 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.
See 1 more

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

Treatment Details

Interventions

  • Personalized OSA Treatment
Trial OverviewThe 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.
Participant Groups
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 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

Since 1981, continuous positive airway pressure (PAP) technology has significantly advanced, offering various devices that effectively treat different types of sleep-disordered breathing, including obstructive sleep apnea (OSA) and central sleep apnea (CSA).
Newer PAP devices, such as autotitrating and bilevel PAP, provide tailored treatment options that can address multiple breathing issues simultaneously, enhancing patient comfort and treatment efficacy.
Positive Airway Pressure Device Technology Past and Present: What's in the "Black Box"?Brown, LK., Javaheri, S.[2018]
In a study of 52 patients with obstructive sleep apnea (OSA) who struggled with CPAP therapy, bilevel positive airway pressure (BPAP) was found to significantly improve adherence, with patients using BPAP for an average of 7 hours per night compared to just 2.5 hours with CPAP.
BPAP also required lower pressure settings than CPAP and resulted in better symptom control, as indicated by a decrease in the Epworth Sleepiness Scale score, demonstrating its potential as a more tolerable alternative for patients who cannot adhere to CPAP.
BPAP is an effective second-line therapy for obese patients with OSA failing regular CPAP: A prospective observational cohort study.Ishak, A., Ramsay, M., Hart, N., et al.[2021]
Bilevel positive airway pressure (BPAP) therapy can be an effective alternative for patients with obstructive sleep apnea (OSA) who either do not respond well to continuous positive airway pressure (CPAP) or find it uncomfortable, potentially providing better ventilation at lower pressures.
The review discusses clinical guidelines for identifying suitable candidates for BPAP and offers insights on how to manually adjust BPAP settings for optimal treatment, particularly in patients with OSA complicated by conditions like chronic obstructive pulmonary disease or severe obesity.
Bilevel positive airway pressure for obstructive sleep apnea.Mansukhani, MP., Kolla, BP., Olson, EJ., et al.[2014]

References

Positive Airway Pressure Device Technology Past and Present: What's in the "Black Box"? [2018]
BPAP is an effective second-line therapy for obese patients with OSA failing regular CPAP: A prospective observational cohort study. [2021]
Bilevel positive airway pressure for obstructive sleep apnea. [2014]
Sleep-Related Breathing Disorders: When CPAP Is Not Enough. [2022]
Positive pressure therapy. [2019]
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]
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]
[Efficacy of demand of positive airway pressure therapy for treating obstructive sleep apnea syndrome]. [2018]
From CPAP to tailored therapy for obstructive sleep Apnoea. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Treatment of obstructive sleep apnea syndrome. [2010]
11.United Statespubmed.ncbi.nlm.nih.gov
Personalized Medicine for Obstructive Sleep Apnea Therapies: Are We There Yet? [2017]