Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Obstructive Sleep Apnea
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT03536572
Collaborators
Not Provided
Investigators
Principal Investigator: Carl J Stepnowsky, Jr., PhD VA San Diego Healthcare System, San Diego, CA