Self-Management of Continuous Positive Airway Pressure Settings
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of
      millions of Americans. Per the Institute of Medicine new treatment adherence strategies are
      needed to help improve the quality of care, reduce social and economic costs, and help those
      with chronic conditions, including OSA, live healthier and more productive lives through
      better management of their conditions. Adherence with continuous positive airway pressure
      (PAP) therapy is disappointingly low, and new methods to increase both the use and efficacy
      of therapy are needed. Historically, patients have not been formally instructed to adjust
      their pressure settings on their PAP devices; practically, however, allowing patients to
      adjust their pressure settings fosters engagement, self-confidence, and control with therapy.
    

Detailed description: 
      Because of clinical demands, patients are often under-educated and under-supported about the
      features of their positive airway pressure (PAP) devices. The most engaged patients are ones
      who understand the details of their device and change the feature settings so that they can
      maximize the benefits of therapy. Features settings include humidification level, expiratory
      pressure relief, pressure ramping, mask alert, auto pressure start, among other important
      comfort features. Historically, patients have not been provided with access to alter or
      modify therapy pressure settings, which requires physician prescription. Allied medical staff
      can carry out subsequent pressure setting changes. It is clear that it is difficult for the
      healthcare system to engage in optimal chronic disease management, and accommodate the needs
      of sleep apnea patients early in the treatment initialization process, which requires
      multiple visits/contacts to ensure that patients are maximizing the use of therapy.

      The overarching aim of the proposed project is to examine the effect of providing patients
      with the ability to adjust their PAP pressure levels on therapy adherence and outcomes. To
      answer these research questions, the proposed randomized, controlled two-group trial of Sleep
      Apnea Self-Management Program (SM) and SM plus Individualized Pressure Adjustment (IPA) has
      the following specific aims related to APAP adherence and efficacy, patient-reported
      outcomes, and utilization: (1) To examine the effect of Individualized Pressure Adjustment
      (IPA) of settings on treatment adherence and efficacy (i.e., mask leak and residual
      apnea-hypopnea index); (2) To examine the effect of SM+IPA versus SM on patient self-reported
      treatment outcomes; and (3) To describe the effects of SM-IPA and SM groups on utilization.

      Sleep apnea is one of the most common chronic conditions in the VA. Positive airway pressure
      (PAP) therapy is the gold-standard therapy for sleep apnea, but adherence with PAP is
      suboptimal. VA sleep programs are understaffed relative to clinical demand for education and
      support. While adaption to PAP therapy has traditionally been achieved through sequential
      visits and pressure changes initiated by providers during office-based care, self-monitoring
      and individualized pressure adjustment is an important strategy that would empower Veterans
      to achieve better control of their OSA. The key impacts of this project are significant for
      both patients (improved outcomes) and the VA (improved staff efficiencies).

      While patients have control over a wide range of comfort features on their PAP devices,
      historically they have not been formally educated and supported to adjust pressure settings.
      The unique aspect of this study is the focus on individualizing pressure settings to allow
      for the maximizing therapeutic benefit, including increased PAP adherence. Importantly, this
      is done within the context of provider oversight.

      The proposed study is a 6-month randomized, controlled, non-blinded, single-center study
      comparing the Sleep Apnea Self-Management Program (SM) to SM plus Individualized Pressure
      Adjustment (IPA). Both groups will receive the SM protocol to ensure that they receive
      identical OSA and PAP education and support. Participants in the intervention arm will be
      provided with additional education and support that will allow them to adjust their PAP
      pressures.

      Positive findings from this study will result in a Toolkit that can be distributed to provide
      patients and providers with the knowledge necessary to improve the clinical management of
      OSA.
    

Intervention name(s): Sleep Apnea Self-Management Program
Intervention type(s): Behavioral
Intervention description(s): Protocol-based sleep apnea and CPAP education and support
Other intervention name(s): SASMP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Sleep Apnea Syndromes; Chronic Disease; Adherence; Self-Care; Patient Outcomes