Lifestyle Counseling + PAP Therapy for Obstructive Sleep Apnea
(MaST Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Miami
Must not be taking: Oral corticosteroids
Disqualifiers: Diabetes, Heart failure, Cancer, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this research study is to see if obstructive sleep apnea (OSA) is associated with abnormalities in fat metabolism. Through this research study, the Investigator will evaluate how fat is metabolized in people with and without sleep apnea, what substances the fat tissue releases, and how these substances might change the way the body uses energy and sugar.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use oral corticosteroids or have unstable medical conditions. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the treatment Lifestyle Counseling + PAP Therapy for Obstructive Sleep Apnea?
Research shows that lifestyle counseling, which includes motivational interviewing and brief action planning, can help patients adopt healthier behaviors by increasing their motivation and commitment to change. This approach, combined with the use of PAP therapy (a machine that helps keep your airways open while you sleep), may improve outcomes for patients with obstructive sleep apnea by addressing both behavioral and physical aspects of the condition.
12345Is lifestyle counseling and PAP therapy safe for humans?
Lifestyle counseling, which includes techniques like motivational interviewing, is generally considered safe and is used to help people adopt healthier habits. PAP therapy, including CPAP, BiPAP, and APAP, is widely used for treating sleep apnea and is generally safe, though some people may experience minor side effects like nasal congestion or discomfort.
24567How is the Lifestyle Counseling + PAP Therapy treatment for obstructive sleep apnea different from other treatments?
This treatment is unique because it combines lifestyle counseling, which helps patients make healthier choices, with PAP therapy, a common method that uses air pressure to keep airways open during sleep. The combination aims to improve adherence and effectiveness by addressing both behavioral and physical aspects of sleep apnea.
89101112Eligibility Criteria
This trial is for adults aged 18-70 with moderate-to-severe obstructive sleep apnea who can use a PAP device for at least 4 hours on most nights. It's not for those with diabetes, severe heart conditions, certain sleep disorders, or a BMI over 40. Participants should not be using other OSA treatments or involved in another clinical study.Inclusion Criteria
I use a CPAP machine for more than 4 hours a night, most nights.
I have moderate-to-severe sleep apnea.
Ability to provide consent
+2 more
Exclusion Criteria
I do not have any severe health conditions like uncontrolled heart issues, severe lung disease, or major depression.
I use or have used a CPAP machine or oral appliance for sleep apnea.
I have diabetes (Type 1 or Type 2).
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
3-4 weeks
Several testing procedures
Treatment
Participants receive Lifestyle Intervention and/or PAP therapy for 12 weeks
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 3 months
Participant Groups
The study looks at how fat metabolism might be different in people with obstructive sleep apnea compared to those without it. It involves lifestyle counseling and the use of Positive Airway Pressure (PAP) therapy to see if these interventions affect body energy and sugar usage.
3Treatment groups
Experimental Treatment
Active Control
Group I: PAP Therapy and Lifestyle Intervention (Aim 2) GroupExperimental Treatment2 Interventions
Participants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive the PAP therapy and Lifestyle Intervention for 12 weeks.
Group II: Lifestyle Intervention Only (Aim 2) GroupExperimental Treatment1 Intervention
Participants in the Aim 1 Group found to have moderate to severe OSA (defined as having a Apnea-Hypopnea Index (AHI) of 15.0 events/hour or more) randomized to this arm will receive only the Lifestyle Intervention for 12 weeks.
Group III: No Intervention (Aim 1) GroupActive Control1 Intervention
Participants in this group will not receive an intervention and will only undergo several testing procedures conducted within 3 to 4 weeks to assess OSA severity.
Lifestyle Counseling Intervention is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Lifestyle Counseling Intervention for:
- Obstructive Sleep Apnea (OSA)
🇪🇺 Approved in European Union as Lifestyle Counseling Intervention for:
- Obstructive Sleep Apnea (OSA)
- Sleep Disorders
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?
University of MiamiLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Facilitating patient participation: the doctor-patient encounter. [2005]Our purpose in undertaking this review has been to extract from the literature behavioral prescriptions for physicians and strategies for prevention. We have demonstrated that the physician who wishes to be a successful counselor needs to ensure that the patient knows what to do, work toward patient commitment to behavior change, negotiate and tailor the specifics of the treatment, and be a warm, attentive interviewer who provides support to patients by attending to emotional responses as they arise. We have suggested ways that the encounter can be embedded in a functioning primary care organization where other members of the team are involved, and where follow-up mobilization of social support and the systematic application of behavioral techniques can achieve permanent behavior change.
Using motivational interviewing and brief action planning for adopting and maintaining positive health behaviors. [2023]Lifestyle medicine practice can be enhanced with interpersonal communication skills to help patients adopt and maintain positive health behaviors, such as improving diet or initiating exercise. We review two approaches that incorporate evidenced-based skills for this purpose: motivational interviewing and brief action planning (BAP). Motivational interviewing involves four processes conducted in a climate of compassion, acceptance, partnership, and empowerment. First, "engaging" (or connecting) with patients uses the "relational" skills of active listening and empathic communication. Second, "focusing" elicits patients' full spectrum of concerns, expectations, and desires to negotiate a collaborative agenda. Third, "evoking motivation," utilizes uniquely innovative skills (e.g., "softening sustain talk" and "cultivating change talk") to increase intrinsic motivation of patients with ambivalence (or resistance) to become more open to choosing healthier behaviors for themselves. Fourth, "planning for change," uses collaborative goal-setting skills to help patients specify concrete action plans for health. To this end, brief action planning (BAP) has been developed as a specific pragmatic algorithmic approach, utilizing collaborative "SMART" (specific, measurable, achievable, relevant, and time-based) action planning, encouragement of patient commitment statements, scaling for confidence, problem-solving to reduce barriers for change, fostering patient accountability, and emphasizing follow-up. BAP can be introduced at any point in a patient encounter when patients are ready or nearly ready for change.
Collaboration and Negotiation: The Key to Therapeutic Lifestyle Change. [2023]Counseling patients on behavior change is an important skill that traditional medical training does not emphasize. Most practitioners are trained in the expert approach to handle problems, which is useful in the acute care setting. However, in the case of chronic disease, a coach approach is more effective. This approach allows the patient to reflect on his or her own motivators for change as well as obstacles hindering the change. Changing from the expert approach to the coach approach is contingent on the lifestyle medicine practitioner sharing information when the patient is ready to receive it, listening mindfully, asking open-ended questions, treating problems as opportunities to learn and grow, and encouraging patients to take responsibility for their actions. By collaborating with the patient, the practitioner can guide patients to find solutions to the problems they are facing and foster an environment that leads patients to self-discovery, accepting responsibility for their behaviors, and ultimately, achieving goals that result in healthier daily habits. As a framework and a guide, lifestyle medicine practitioners can use a 5-step cycle of collaboration and a ladder of behavior change when working with patients on behavior change.
Healthier lifestyles: how to motivate older patients to change. [2007]A 1- to 3-minute clear discussion by the family physician of the risks of unhealthy lifestyles has been found to be quite successful in countering patients' denial of personal risk. Studies indicate that the physician's authority lends credibility to the need to make a change and is a strong motivator. An office-based physician counseling model has proven effective in motivating older patients to adopt healthier lifestyles. The model includes four basic steps: patient assessment, discussion of risk and delivery of a message to change, a prescription for change (planning and carrying out of a behavior change strategy), and prevention of relapse through a maintenance program.
How to help patients adopt and maintain a healthy lifestyle? A review of behavioral evidence of determinants and means. [2018]A significant part of the population do not follow dietary and exercise recommendations. In Current Care Guidelines, lifestyle counseling is considered as part of good medical care. Lifestyle diseases are, however, not decreasing. Does counseling fail to reach its goal, or is it being provided at all? In the narrative review article based on systematic surveys, we approach the change in lifestyle through both conscious and automatic psychosocial processes. Research evidence indicates that a change in behavior can be supported through both processes. While intervention studies have been so far conducted mainly by influencing conscious processes, evidence of benefits of using automated processes is growing stronger. We present practical measures to support the desire for change and skills and establishments of habits. The same methods may in part be utilized to change professionals in their own behavior so that provision of quick and simple lifestyle counseling becomes a matter actualized in everyday life.
Role of Counseling to Promote Adherence in Healthy Lifestyle Medicine: Strategies to Improve Exercise Adherence and Enhance Physical Activity. [2023]Although healthy lifestyles (HL) offer a number of health benefits, nonadherence to recommended lifestyle changes remains a frequent and difficult obstacle to realizing these benefits. Behavioral counseling can improve adherence to an HL. However, individuals' motivation for change and resistance to altering unhealthy habits must be considered when developing an effective approach to counseling. In the present article, we review psychological, behavioral, and environmental factors that may promote adherence and contribute to nonadherence. We discuss two established models for counseling, motivational interviewing and the transtheoretical model of behavior change, and provide an example of how these approaches can be used to counsel patients to exercise and increase their levels of physical activity.
Counseling patients for lifestyle change: making a 15-minute office visit work. [2015]Lifestyle counseling is an intervention that can improve chronic disease management as well as patient and provider satisfaction. Patients and providers are often frustrated with difficulties faced in the implementation and maintenance of lifestyle change. Can we change this paradigm? Are there new strategies that work and can be implemented in a typical office visit? The medical literature confirms the effectiveness of lifestyle interventions and recommends that lifestyle counseling be considered as a cornerstone of care. Here we present a case study of a midlife woman to show how motivational interviewing can be used to help her identify and meet her health goals.
Positive Airway Pressure Therapy for Obstructive Sleep Apnea. [2017]Positive airway pressure (PAP) is considered first-line therapy for moderate to severe obstructive sleep apnea and may also be considered for mild obstructive sleep apnea, particularly if it is symptomatic or there are concomitant cardiovascular disorders. Continuous PAP is most commonly used. Other modes, such as bilevel airway pressure, autotitrating positive airway pressure, average volume assured pressure support, and adaptive support ventilation, play important roles in the management of sleep-related breathing disorders. This article outlines the indications, description, and comfort features of each mode. Despite the proven efficacy of PAP in treating obstructive sleep apnea syndrome and its sequelae, adherence to therapy is low. Close follow-up of patients for evaluation of adherence to and effectiveness of treatment is important.
Adherence to positive airway pressure therapy in adults and children. [2012]Positive airway pressure (PAP) therapy is commonly prescribed treatment for obstructive sleep apnea (OSA) in both adults and children. However, the effectiveness of PAP therapy is undermined by poor adherence. The purpose of this review is to improve our understanding of the causes and consequences of nonadherence to PAP therapy and highlight interventions that promote adherence.
[Conservative treatment of obstructive sleep apnea using non-PAP therapies]. [2020]In Germany about one third of adults aged between 30 and 69 years suffer from obstructive sleep apnea (OSA). Snoring, inspiratory flow limitations, hypopneas, and apneas occur, leading to disturbed sleep, reduced daytime performance, and increased cardiovascular morbidity and mortality. Positive airway pressure therapy (PAP therapy) can be successfully administered in every OSA severity. However, other conservative treatments have to be considered for some patients, particularly in PAP failure or intolerance. The individual treatment concept is based on poly(somno)graphic, morphological, and functional assessment, taking treatment acceptance, adherence, and compliance into account.
Treatment of obstructive sleep apnea syndrome. [2010]Several treatment options are available for obstructive sleep apnea syndrome (OSAS), including various types of positive airway pressure (PAP) therapy, oral appliances, surgery, and conservative approaches including weight loss and positional therapy. This article focuses on continuous positive airway pressure treatment and technological advancements in the delivery of PAP therapy for OSAS, reviews indications for treatment, treatment outcomes, and methods of improving compliance, and discusses the other non-PAP treatment options.
A review of EPAP nasal device therapy for obstructive sleep apnea syndrome. [2021]Expiratory positive airway pressure (EPAP) nasal devices provide a new therapeutic option for obstructive sleep apnea (OSA).