PAP Treatment and Sleep Education for Sleep Apnea (RESTORE Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByM. Safwan Badr, MD, MBA
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wayne State University
No Placebo Group
Trial Summary
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.
What data supports the idea that PAP Treatment and Sleep Education for Sleep Apnea is an effective treatment?The available research does not provide specific data on PAP Treatment and Sleep Education for Sleep Apnea. Instead, it discusses therapeutic education for other conditions like asthma, COPD, and atopic dermatitis. These studies show that education programs can improve quality of life and treatment adherence for these conditions. However, without direct evidence for sleep apnea, we cannot conclude the effectiveness of PAP Treatment and Sleep Education for this specific condition based on the provided information.3891013
Do I have to stop taking my current medications for the trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you are using sedative-hypnotic medications above the maximal acceptable therapeutic dose, you may not be eligible to participate.
Is PAP Treatment and Sleep Education a promising treatment for sleep apnea?Yes, PAP Treatment and Sleep Education is promising because it helps patients understand their condition and treatment, encourages them to take an active role in their care, and aims to improve their quality of life.2461112
What safety data exists for PAP treatment and sleep education for sleep apnea?The provided research does not directly address safety data for PAP treatment and sleep education for sleep apnea. However, it highlights the importance of patient education in managing chronic conditions, suggesting that effective education can improve adherence, prevent complications, and enhance quality of life. This implies that well-structured educational programs, which are part of the treatment, could contribute to patient safety by ensuring better management of the condition.125710
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
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.
I have been diagnosed with central sleep apnea.
I do not have severe sleep disorders like insomnia or narcolepsy.
I use sleep or anxiety medication more than the recommended dose.
Participant Groups
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.
2Treatment groups
Active Control
Group I: Sleep Education IActive Control1 Intervention
Participants will attend four weekly sessions to receive education about strategies to improve sleep.
Group II: PAP TreatmentActive Control1 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, Australia 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)
🇦🇺 Approved in Australia as CPAP Therapy for:
- Obstructive Sleep Apnea (OSA)
- Central Sleep Apnea (CSA)
- Sleep-Disordered Breathing (SDB)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Wayne State UniversityDetroit, MI
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Who is running the clinical trial?
Wayne State UniversityLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Techniques and impact of education in adult asthmatics. [2016]A major cause for the discrepancy between the increase of mortality and morbidity due to asthma and advances in clinical assessment and treatment of the disease is inefficient asthma management. Patient education is a powerful tool for helping patients to gain the motivation and skills to control their asthma. An effective teaching and treatment programme for asthmatics should include information about the disease, prevention and treatment of asthma attacks and bronchial infections, and training of self-management of airflow limitation by the patients. On the basis of the currently evaluated programmes for asthmatic adults, patient education diminishes the frequency of asthma attacks and decreases the disability of the patients. By a reduction of emergency treatments, hospitalizations, and days lost from work a decrease in the costs of the often life-long treatment of asthmatics can be expected. Therefore, patient education should be an integrated part of current asthma management.
Outcome factors in patient education. [2019]Patient education requires a thorough knowledge of the subject and accurate assessment of patient abilities, readiness, and motivation. The teaching process involves agreement between the PA and the patient on what is to be learned and a clear, hands-on presentation that uses visual and other aids as appropriate. Feedback is essential, both from the PA in the form of correction and rewards and from the patient to draw attention to areas that need further clarification. As it can be extremely difficult to persuade a patient to modify his/her lifestyle over the long term, repetition and a flexible approach are vital.
[Educating the asthma patient for routine illness management. Assuring long-term therapeutic success]. [2007]Although education programs for adult asthmatics promotes improved knowledge of the disease, it has been found that this alone does not result in any change in patient behavior. Against this background, the National Asthma Education Program Expert Panel (NAEP) recommends adapting the contents of the education programs more closely to the needs of the individual patient. This is to be achieved through self-monitoring, more influence on environmental factors, improved knowledge of the disease process and self-medication skills, and greater self-sufficiency on the part of the patient. Other studies have discussed various possible ways of implementing these recommendations, including the training of physical self-awareness, consideration and correction of subjective notions of the disease, dealing with disease-related emotions, and providing concrete advice on coping with the situations met with in daily life. A new patient education program developed by the Alpenklinik in Oberjoch serves to illustrate how the NAEP recommendations can be implemented.
Current perspectives of therapeutic patient education in Italy. [2019]Therapeutic patient education is a well-defined branch of health education aimed at patient empowerment. It consists of helping the patient to understand his own disease and its treatment, actively collaborating to its fulfillment and to take care of his own health status in order to maintain and improve his life quality. The correct implementation of both communication and therapeutic patient education involves the mastery of specific professional skills by healthcare personnel. In Italy, institutional therapeutic patient education is delivered mainly to diabetic patients. However, other activities and projects aimed at therapeutic education of chronic patients are gradually appearing. An overview of current situation and perspective of therapeutic patient education practice in Italy are presented.
Applying health education theory to patient safety programs: three case studies. [2016]Program planning for patient safety is challenging because intervention-oriented surveillance data are not yet widely available to those working in this nascent field. Even so, health educators are uniquely positioned to contribute to patient safety intervention efforts because their theoretical training provides them with a guide for designing and implementing prevention programs. This article demonstrates the utility of applying health education concepts from three prominent patient safety campaigns, including the concepts of risk perception, community participation, and social marketing. The application of these theoretical concepts to patient safety programs suggests that health educators possess a knowledge base and skill set highly relevant to patient safety and that their perspective should be increasingly brought to bear on the design and evaluation of interventions that aim to protect patients from preventable medical error.
[From Neandertal to therapeutic education]. [2016]Therapeutic education will be part of every patient's care. It is not an additional tool in the medical care but a new way to consider the relationship between patients and physicians. In therapeutic education, the medical knowledge transfer is essential but probably insufficient to obtain a real change in the patient's behaviour. Looking back, the origins of the words may help patients and physicians understand the real issues of therapeutic education and therefore, render it more efficient.
Therapeutic patient education in atopic eczema. [2014]Therapeutic patient education (TPE) is a patient-centred process that entails the transfer of skills (e.g. self-management, treatment adaptation) from a trained healthcare professional to patients and/or their carers. TPE has been shown to help improve adherence, prevent complications, and improve quality of life (QoL) in chronic illnesses such as diabetes, asthma and cardiovascular disease. Recently, TPE recommendations for patients with atopic eczema have been proposed. TPE is a four-step process: understanding the patient's knowledge, beliefs and hopes; setting age-appropriate educational objectives; helping the patient (or carer) to acquire skills; and assessing the success of the programme. TPE programmes always involve a multidisciplinary team of healthcare professionals, including nurses, psychologists, doctors and dieticians who are expert in the disease area. TPE should be offered to (never forced upon) any patient who has experienced treatment failure, or to families who feel they lack social support. High-quality TPE programmes should be evidence-based, tailored to a patient's individual educational and cultural background (rather than being standardized in form and content), and have well-defined content and activities.
[Therapeutic education of children who are victims or at risk of a stroke]. [2017]Therapeutic patient education is one of the health improvement projects. It provides personalised support for a child who has suffered or is at risk of suffering a stroke, and their family. This approach requires the sharing and transfer of knowhow, behaviour and attitude on the part of specially trained health professionals.
Therapeutic patient education in children with moderate to severe atopic dermatitis: A multicenter randomized controlled trial in China. [2018]Therapeutic patient education is a continuous, systematic, patient-centered learning process to help patients and their families acquire and maintain the skills they need to manage their lives with a chronic disease. It has been proven effective in increasing treatment adherence and improving quality of life for patients with atopic dermatitis (AD) in Western countries. We introduce the first multicenter, randomized controlled clinical trial of therapeutic patient education in Chinese children with AD.
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]Therapeutic patient education (TPE) improves quality of life and reduces health care utilization among patients with chronic obstructive pulmonary disease (COPD). However, benefits from TPE might depend on the performance of the educators and training is needed to ensure the effective delivery of TPE interventions. Based on the framework by Moore et al. (J Contin Educ Health Prof 29:1-15, 2009), we will compare the impact of two continuing education (CE) activities on TPE in regard to the following educational outcomes: (1) learning, (2) self-report of competence, (3) performance of the educators, and (4) outcomes of COPD patients who will meet the newly trained educators for TPE.
[Therapeutic Patient Education training for nursing students: A case study.] [2019]Many educational institutions offer professionals continuing education in therapeutic patient education (TPE). Some also provide it for students in initial training.
[Education care in patients with psychiatric disorders in France: Psychoeducation or therapeutic patient education?] [2019]Psychoeducation and therapeutic patient education can be effectively included in treatments for patients with psychiatric disorders. These two effective educational therapies have the common purpose of improving disorder-related morbidity, compliance with treatment and patients' quality of life. While they have different methods of application, both teach patients to play an active role in their own care. However, it is still critical to combine them for care of patients with psychiatric and addiction disorders in a manner that allows for specificity. To do this, the differences between psychoeducation and therapeutic patient education must be considered, and their potential for the management of patients with psychiatric and addiction disorders must be determined.
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]Patient education is fundamental in asthma management, especially at pediatric age. It is increasingly recognized as effective in reducing the burden of the disease, but is less clear in improving the quality of life of children with asthma and their parents. This study assessed the effect of an asthma therapeutic education program on pulmonary function and quality of life in children with asthma and their parents.