PAP Treatment and Sleep Education for Sleep Apnea

(RESTORE Trial)

Overseen By Nishtha H Pandya

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wayne State University

Must not be taking: Sedative-hypnotics

Disqualifiers: Severe respiratory, cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how breathing problems during sleep and insufficient sleep contribute to daytime sleepiness. The researchers are testing two programs to determine which one most effectively reduces daytime sleepiness. One group will use a device called PAP (Positive Airway Pressure), while the other will attend sessions to learn about better sleep habits. Individuals with mild to moderate sleep breathing issues who frequently lack sufficient sleep may be suitable for this study. As an unphased trial, this study provides a unique opportunity to explore new methods for improving sleep quality and reducing daytime sleepiness.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using sedative-hypnotic medications above the recommended dose, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PAP (Positive Airway Pressure) treatment is generally well-accepted by adults with obstructive sleep apnea (OSA). Studies have found that PAP can significantly reduce the severity of OSA, as well as decrease sleepiness and high blood pressure. However, some people might experience common issues like a leaky mask, a stuffy nose, or a dry mouth. One study noted a higher risk of throat infections, especially if the PAP machine is used without added moisture. Despite these minor issues, PAP is widely recommended for its benefits in managing OSA.

Specific safety data for Sleep Education programs is not available, but as these are educational sessions rather than medical treatments, they are likely very safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PAP Treatment and Sleep Education methods for sleep apnea because they offer a more comprehensive approach compared to traditional treatments like CPAP machines alone. PAP Treatment combines the use of a positive airway pressure device with educational sessions, empowering patients to better understand and manage their condition. Meanwhile, the Sleep Education arm aims to improve sleep quality through targeted strategies, which could enhance overall treatment effectiveness. This holistic approach not only addresses physical symptoms but also equips patients with knowledge and skills to potentially improve long-term health outcomes.

What evidence suggests that this trial's treatments could be effective for sleep apnea?

This trial will compare PAP (Positive Airway Pressure) treatment with sleep education programs for sleep apnea. Studies have shown that PAP treatment effectively addresses sleep apnea, a condition that causes daytime sleepiness. Research indicates that PAP treatment can improve sleep quality and reduce daytime fatigue in individuals with obstructive sleep apnea (OSA). One study found that regular use of PAP therapy is associated with increased longevity and a lower risk of heart problems. Another review supports its use as a standard treatment for OSA due to its effectiveness. In contrast, sleep education programs, another focus of this trial, teach methods to enhance sleep but may lack the same level of direct evidence as PAP for reducing sleep apnea symptoms. ^{1 6 7 8 9}

Who Is on the Research Team?

M. Safwan Badr, MD, MBA

Principal Investigator

Wayne State University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with mild to moderate sleep disordered breathing (SDB) and who often get less than 7 hours of sleep. They should feel sleepy during the day, but not be at high risk for falling asleep in dangerous situations like driving. People using certain sleep medications or treatments, those with severe health issues, substance use disorders, or other major sleep conditions can't join.

Inclusion Criteria

You usually sleep less than 7 hours for at least 4 nights every week, as recorded in your sleep diary.

I have been diagnosed with a mild to moderate sleep breathing issue.

I am over 18 years old.

Exclusion Criteria

I am a commercial driver or at high risk for car accidents.

I do not have severe lung or heart disease.

I am currently using a device at night to help with my sleep breathing problem.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual or in-person)

Treatment

Participants receive education about SDB and sleep, with one group receiving PAP devices, over four weekly sessions

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments conducted immediately following the intervention and after 3 months

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PAP Treatment
• Sleep Education I
• Sleep Education II

Trial Overview The study aims to see which of two programs—PAP Treatment or Sleep Education I—is better at reducing daytime sleepiness for people with SDB and insufficient nightly sleep. Participants will try one of these approaches to find out how it affects their alertness during the day.

How Is the Trial Designed?

Group I: Sleep Education I Active Control 1 Intervention

Participants will attend four weekly sessions to receive education about strategies to improve sleep.

Group II: PAP Treatment Active Control 1 Intervention

Participants will receive a PAP device and will attend four weekly sessions to receive education about this treatment.

PAP Treatment is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as CPAP Therapy for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)
• Sleep-Disordered Breathing (SDB)

Approved in United States as CPAP Therapy for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)
• Sleep-Disordered Breathing (SDB)

Approved in Canada as CPAP Therapy for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)
• Sleep-Disordered Breathing (SDB)

Approved in Japan as CPAP Therapy for:

• Obstructive Sleep Apnea (OSA)
• Central Sleep Apnea (CSA)
• Sleep-Disordered Breathing (SDB)

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Effective patient education relies on a strong understanding of the subject and an accurate assessment of the patient's abilities and motivation, ensuring that both the patient and the provider agree on learning goals.

The teaching process should be interactive and adaptable, using visual aids and feedback to reinforce learning, while also emphasizing the importance of repetition to encourage long-term lifestyle changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome factors in patient education. Hafstad, L.[2019]

Therapeutic patient education is crucial for empowering patients by helping them understand their diseases and treatments, which can lead to better health management and improved quality of life.

In Italy, while therapeutic education is primarily focused on diabetic patients, there is a growing trend of expanding these educational practices to other chronic conditions, indicating a shift towards more comprehensive patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current perspectives of therapeutic patient education in Italy. Marcolongo, R., Rossato, E., Pavan, V., et al.[2019]

The study involved 19 semi-structured interviews with various stakeholders in nurse training, highlighting the importance of multiprofessional teaching methods and diverse pedagogical activities like role-playing to enhance student competencies in therapeutic patient education (TPE).

The training programs were found to align with established quality criteria, suggesting that similar training could be effectively implemented for other healthcare students or in interprofessional settings, although further assessment of the training's impact is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic Patient Education training for nursing students: A case study.] Kaci, C., Crozet, C., Gillard-Berthod, C., et al.[2019]

Health educators can play a crucial role in enhancing patient safety by applying their training in designing and implementing prevention programs, despite the current lack of comprehensive surveillance data.

Utilizing concepts from successful patient safety campaigns, such as risk perception and community participation, can improve the effectiveness of interventions aimed at reducing preventable medical errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying health education theory to patient safety programs: three case studies. Gilkey, MB., Earp, JA., French, EA.[2016]

Therapeutic patient education (TPE) is an effective, patient-centered approach that enhances self-management and treatment adherence in chronic illnesses, including atopic eczema, by transferring essential skills from healthcare professionals to patients and their caregivers.

TPE involves a structured four-step process and requires a multidisciplinary team, ensuring that educational programs are tailored to individual patient needs and cultural backgrounds, which can significantly improve quality of life and prevent complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic patient education in atopic eczema. Barbarot, S., Stalder, JF.[2014]

A multicenter, randomized controlled trial involving 580 Chinese children aged 2-14 with moderate to severe atopic dermatitis showed that therapeutic patient education significantly reduced eczema severity and improved quality of life after 6 months.

The intervention group not only had a greater reduction in atopic dermatitis severity scores but also demonstrated improved knowledge about the use of emollients, highlighting the effectiveness of education in managing chronic skin conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic patient education in children with moderate to severe atopic dermatitis: A multicenter randomized controlled trial in China. Liang, Y., Tian, J., Shen, CP., et al.[2018]

Psychoeducation is underutilized in psychiatry, despite its potential benefits, while the use of therapeutic patient education programs has increased but still represents less than 4% of validated programs in France, indicating a need for greater implementation.

Therapeutic patient education has a legal framework and established guidelines, making it a valuable approach for improving patient engagement and treatment outcomes in psychiatric and addiction disorders, ultimately enhancing patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Education care in patients with psychiatric disorders in France: Psychoeducation or therapeutic patient education?] Lang, JP., Jurado, N., Herdt, C., et al.[2019]

This study aims to evaluate the effectiveness of two different continuing education (CE) activities for educators on therapeutic patient education (TPE) for COPD patients, focusing on learning outcomes, self-reported competence, educator performance, and patient outcomes.

By comparing a role-playing simulation (experimental group) to a traditional lecture (comparison group), the study seeks to determine which method better enhances educator performance in delivering TPE, ultimately aiming to improve the quality of life and reduce healthcare utilization for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative impact of two continuing education activities targeted at COPD educators on educational outcomes: protocol for a non-randomized controlled study using mixed methods. Gagné, M., Moisan, J., Lauzier, S., et al.[2019]

Therapeutic education is essential in patient care, emphasizing a new approach to the relationship between patients and physicians rather than just an additional tool.

Effective therapeutic education requires more than just transferring medical knowledge; it aims to foster real behavioral changes in patients for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[From Neandertal to therapeutic education]. Houppe, JP.[2016]

Therapeutic patient education is a health improvement initiative that offers personalized support to children at risk of stroke and their families.

This approach relies on specially trained health professionals to share knowledge, behaviors, and attitudes necessary for effective care and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic education of children who are victims or at risk of a stroke]. Micaëlli, D.[2017]

Education programs for adult asthmatics improve knowledge about asthma but do not change patient behavior, highlighting the need for more personalized approaches.

The National Asthma Education Program recommends tailoring education to individual needs, focusing on self-monitoring, environmental influences, and self-medication skills to enhance patient self-sufficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Educating the asthma patient for routine illness management. Assuring long-term therapeutic success]. Heinl, KW., Goldt, S., Hägele, R., et al.[2007]

Patient education is crucial for effective asthma management, as it empowers patients with the knowledge and skills needed to control their condition, leading to fewer asthma attacks and reduced disability.

Implementing educational programs can lower the need for emergency treatments and hospitalizations, ultimately decreasing healthcare costs associated with long-term asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques and impact of education in adult asthmatics. Worth, H.[2016]

A family-based asthma education program significantly improved the quality of life for both children with asthma and their parents, as shown in a study involving 34 families in each group over a 12-month period.

Children with non-allergic asthma in the experimental group demonstrated better pulmonary function, specifically in forced expiratory maneuvers, compared to the control group, highlighting the program's effectiveness in managing asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Family Empowerment Education on Pulmonary Function and Quality of Life of Children With Asthma and Their Parents in Tunisia: A Randomized Controlled Trial. Dardouri, M., Sahli, J., Ajmi, T., et al.[2021]

Citations

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Positive airway pressure therapy adherence and outcomes in ... The present study sought to determine the efficacy of the present definition of PAP therapy adherence on longitudinal outcomes in patients with OSA.

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Treatment of Adult Obstructive Sleep Apnea With Positive ... The purpose of this systematic review is to provide supporting evidence for the clinical practice guideline for the treatment of obstructive sleep apnea (OSA) ...

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Positive airway pressure therapy adherence and outcomes ... The present study sought to determine the efficacy of the present definition of PAP therapy adherence on longitudinal outcomes in patients with OSA.

4. thelancet.com thelancet.com/journals/lanres/article/PIIS2213-2600(25)00002-5/abstract

Positive airway pressure therapy and all‐cause and ... Our results are consistent with a potentially beneficial effect of PAP therapy on all-cause and cardiovascular mortality in patients with OSA.

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823539

Positive Airway Pressure, Mortality, and CV Risk in Older ... In this cohort study of Medicare beneficiaries with OSA, PAP utilization was associated with lower all-cause mortality and MACE incidence.

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/resp.13808

Clinical side effects of continuous positive airway pressure ... In one study, OSA patients using CPAP therapy either with or without heated humidity had increased risk of upper airway infections compared to ...

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May continuous positive airway pressure (CPAP) treatment ... CPAP treatment would reduce this risk by correcting the hypoxic burden and sleep fragmentation. However, randomized controlled trials failed to ...

8. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.7640

Treatment of Adult Obstructive Sleep Apnea with Positive ... This guideline establishes clinical practice recommendations for positive airway pressure (PAP) treatment of obstructive sleep apnea (OSA) in adults.

9. mayoclinic.org mayoclinic.org/diseases-conditions/sleep-apnea/in-depth/cpap/art-20044164

CPAP machines: Tips for avoiding 10 common problems Common problems with CPAP include a leaky mask, trouble falling asleep, a stuffy nose and a dry mouth.