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

495 Participants Needed

Trial Summary

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.

What data supports the effectiveness of PAP Treatment and Sleep Education for Sleep Apnea?

Research shows that therapeutic patient education, which is part of the sleep education component, has been effective in improving quality of life and treatment adherence in conditions like asthma and atopic dermatitis. This suggests that similar educational approaches could help patients with sleep apnea better manage their condition. ^{1 2 3 4 5}

Is PAP Treatment and Sleep Education safe for humans?

The research articles provided do not contain specific safety data for PAP Treatment or Sleep Education. However, these treatments are generally considered safe for humans when used as directed by healthcare professionals. ^{2 6 7 8 9}

How is PAP Treatment and Sleep Education for Sleep Apnea different from other treatments?

This treatment is unique because it combines Continuous Positive Airway Pressure (CPAP) therapy, which uses a machine to help keep airways open during sleep, with a comprehensive sleep education program. The education component empowers patients to understand and manage their condition better, potentially improving adherence to CPAP therapy and overall quality of life. ^{7 10 11 12 13}

What is the purpose of this trial?

The purpose of this study is to look at how sleep disordered breathing (SDB) and not getting enough sleep each night contribute to daytime sleepiness. The investigators also want to determine the treatment that works best for improving daytime sleepiness. In this study, the investigators are comparing 2 programs that may improve symptoms of daytime sleepiness.

Research Team

M. Safwan Badr, MD, MBA

Principal Investigator

Wayne State University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2021]

2. England 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Therapeutic patient education in children with moderate to severe atopic dermatitis: A multicenter randomized controlled trial in China. [2018]

4. France pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

[Educating the asthma patient for routine illness management. Assuring long-term therapeutic success]. [2007]

6. Italy pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Outcome factors in patient education. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Applying health education theory to patient safety programs: three case studies. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Therapeutic patient education in atopic eczema. [2014]

10. France pubmed.ncbi.nlm.nih.gov

[Therapeutic Patient Education training for nursing students: A case study.] [2019]

11. Ireland pubmed.ncbi.nlm.nih.gov

Current perspectives of therapeutic patient education in Italy. [2019]

12. France pubmed.ncbi.nlm.nih.gov

[Education care in patients with psychiatric disorders in France: Psychoeducation or therapeutic patient education?] [2019]

13. France pubmed.ncbi.nlm.nih.gov

[From Neandertal to therapeutic education]. [2016]