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IIR 16-277 – HSR&D Study

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IIR 16-277
Self-Management of Continuous Positive Airway Pressure Settings for Veterans with Sleep Apnea
Carl J Stepnowsky, Jr. PhD
VA San Diego Healthcare System, San Diego, CA
San Diego, CA
Funding Period: May 2018 - April 2022

BACKGROUND/RATIONALE:
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.

OBJECTIVE(S):
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 (automatic positive airway pressure) 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.

METHODS:
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.

FINDINGS/RESULTS:
NA

IMPACT:
Positive findings from this study will result in a Toolkit that can be distributed through the VA Sleep Network and the American Sleep Apnea Association to provide patients and providers with the knowledge necessary to improve the clinical management of OSA.

PUBLICATIONS:
None at this time.


DRA: Other Conditions
DRE: Treatment - Efficacy/Effectiveness Clinical Trial, TRL - Applied/Translational
Keywords: Patient Preferences, Patient-Provider Interaction
MeSH Terms: none