Personalized Treatment for Obstructive Sleep Apnea

(PRAISE Trial)

Overseen By Girardin Jean-Louis, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Progressive illnesses, Cognitive impairment, 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: 6 months

330 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how effectively a personalized treatment plan can help individuals adhere to their sleep apnea therapy using Positive Airway Pressure (PAP). Participants will receive either a personalized sleep apnea treatment or standard care for up to six months. The trial seeks participants who are African American, African, Caribbean, or black, aged 60-85, and diagnosed with obstructive sleep apnea. As an unphased trial, it offers participants the chance to contribute to research that could enhance personalized treatment strategies for sleep apnea.

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 prior data suggests that the Personalized OSA Treatment is safe?

Research shows that Positive Airway Pressure (PAP) effectively treats obstructive sleep apnea (OSA). Studies have found that PAP is generally safe and improves sleep quality for many people. These studies have reported no serious safety issues.

PAP treatment involves wearing a mask during sleep to keep airways open, and most people find it comfortable. Some may experience minor side effects like a stuffy or dry nose, but adjusting the equipment usually resolves these issues.

While specific data on the personalized OSA treatment under study is not available, PAP is a common and approved method for treating sleep apnea. Therefore, the personalized treatment, likely building on PAP, is expected to be safe as well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Personalized OSA Treatment because it tailors therapy specifically to the individual needs of those with obstructive sleep apnea (OSA). Unlike traditional treatments like CPAP machines, which provide a one-size-fits-all approach, this personalized method considers unique patient characteristics and preferences, potentially improving comfort and adherence. This innovative approach may lead to more effective management of OSA by ensuring that each patient receives the most suitable treatment, enhancing their overall sleep quality and health outcomes.

What evidence suggests that the Personalized OSA Treatment is effective for sleep apnea?

This trial will compare personalized treatment for obstructive sleep apnea (OSA) with the standard of care. Research has shown that personalized treatment can improve patient adherence to treatment plans. Studies have found that tailoring treatment to individual needs increases regular use of Positive Airway Pressure (PAP) therapy. Consistent use of PAP therapy results in better long-term health, such as reduced heart issues. Personalized treatment is particularly beneficial for those who struggle with standard care. Overall, evidence supports that customizing OSA treatment enhances its effectiveness for patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Girardin Jean-Louis, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Personalized OSA Treatment

Trial Overview

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.

How Is the Trial Designed?

Group I: Personalized OSA Treatment Group Experimental Treatment 2 Interventions

Participants in this group receive personalized OSA treatment for sleep apnea for up to six months.

Group II: Standard of Care Group Active Control 1 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

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+

Published Research Related to This Trial

Bilevel positive airway pressure (BPAP) devices have been developed to effectively treat complex sleep-related breathing disorders that do not respond to traditional CPAP therapy, enhancing patient care for conditions like obstructive sleep apnea (OSA).

Advanced BPAP therapies, including adaptive servoventilation and volume-assured pressure support, provide tailored noninvasive ventilation options to address various hypoventilation disorders and central sleep apnea syndromes, showcasing their versatility in managing complex respiratory issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep-Related Breathing Disorders: When CPAP Is Not Enough. Selim, B., Ramar, K.[2022]

Continuous positive airway pressure (CPAP) therapy is a key treatment for obstructive sleep apnea syndrome (OSAS), and advancements in technology are enhancing its delivery and effectiveness.

The article reviews various treatment options for OSAS, including non-PAP methods like oral appliances and lifestyle changes, highlighting the importance of improving patient compliance with CPAP therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of obstructive sleep apnea syndrome. Freedman, N.[2010]

In a study involving 27 adults with obstructive sleep apnea syndrome (OSAS), both continuous positive airway pressure (CPAP) and novel bilevel (NBL) therapy effectively reduced the apnea-hypopnea index, indicating similar efficacy in treating the condition.

After one month of treatment, compliance rates and improvements in sleepiness and functional outcomes were comparable between CPAP and NBL, suggesting that NBL does not provide additional benefits over CPAP for first-time OSAS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, double-blind clinical trial comparing continuous positive airway pressure with a novel bilevel pressure system for treatment of obstructive sleep apnea syndrome. Gay, PC., Herold, DL., Olson, EJ.[2022]

In a study of 40 patients with obstructive sleep apnea who switched from CPAP to bilevel PAP, significant improvements were observed in therapy tolerance, with a reduction in side effects like mouth dryness and choking sensation after one year.

Patients reported better sleep quality and preferred bilevel PAP over CPAP, with device usage averaging 7 hours per night, indicating that bilevel PAP may enhance adherence to treatment for those struggling with CPAP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Palot, A., Nguyên, XL., Launois, S., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilevel positive airway pressure for obstructive sleep apnea. Mansukhani, MP., Kolla, BP., Olson, EJ., et al.[2014]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Positive airway pressure (PAP) therapies, including CPAP, bilevel positive airway pressure, and auto-CPAP, are effective treatments for obstructive sleep-disordered breathing (OSDB), helping to maintain open airways during sleep.

These therapies work by delivering a continuous flow of air to prevent airway collapse, but they can also have complications, highlighting the need for careful management and monitoring of patients using these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive pressure therapy. Strollo, PJ., Sanders, MH., Atwood, CW.[2019]

Continuous Positive Airway Pressure (CPAP) therapy is the standard treatment for Obstructive Sleep Apnoea (OSA) and is highly effective when used, but its real-world effectiveness is limited due to patient acceptance and usage issues.

There is a growing recognition of OSA's heterogeneity, which suggests that personalized treatment strategies, considering individual anatomical and pathophysiological differences, could improve overall treatment effectiveness and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From CPAP to tailored therapy for obstructive sleep Apnoea. Sutherland, K., Kairaitis, K., Yee, BJ., et al.[2020]

There is currently no reliable method to predict which treatments for obstructive sleep apnea will be most effective for individual patients, highlighting a gap in personalized medicine for this condition.

The review discusses existing personalized approaches to treating obstructive sleep apnea and suggests future directions for developing individualized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Medicine for Obstructive Sleep Apnea Therapies: Are We There Yet? Edwards, BA., Landry, S., Joosten, SA., et al.[2017]

In a study involving 18 patients with obstructive sleep apnea syndrome (OSAS), demand continuous positive airway pressure (nDPAP) was found to be as effective as the traditional manual titering continuous positive airway pressure (nCPAP) in managing the condition.

While both treatments showed similar effectiveness in most sleep and respiratory variables, nCPAP provided better oxygen saturation during REM sleep, indicating a slight advantage in that specific aspect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of demand of positive airway pressure therapy for treating obstructive sleep apnea syndrome]. García Arroyo, I., Terán Santos, J., Cordero Guevara, J., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Airway Pressure Device Technology Past and Present: What's in the "Black Box"? Brown, LK., Javaheri, S.[2018]

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