Self-Management of Continuous Positive Airway Pressure Settings

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.

Inclusion Criteria:

The investigators' intent is to recruit a study population that is representative of
patients diagnosed with OSA. To this end, entry criteria are as inclusive as possible and
operationalized as follows:

- confirmed diagnosis of OSA

- being newly prescribed an OSA therapy

- having chronic symptoms per screening symptom checklist

- fluency in English

OSA diagnosis by the investigators' Pulmonary Sleep Program has been and is currently
consistent with published consensus statements50 that therapy is indicated when the
apnea-hypopnea index (AHI, number of apneas + hypopneas per hour of sleep) is either (1)
>30 or (2) 5-30 AND accompanied by documented OSA symptoms, including EDS, impaired
cognition, mood disorders, insomnia, or documented cardiovascular diseases. Because sleep
apnea is of increasing importance in women, the investigators' plan is to oversample women
by 50% so that they represent 15% of the final study sample.

Exclusion Criteria:

Criteria for exclusion include:

- cognitive impairment sufficient to cause inability to complete the protocol (e.g.,
documented MMSE < 24/30)

- low health literacy

- residence in a geographical area outside of San Diego County (which could make some
necessary in-person visits difficult)

- fatal comorbidity (life expectancy <6 months as indicated by treating physician)

- significant documented substance/chemical abuse

- other participant circumstances or characteristics that, in the opinion of a consensus
of study team, would interfere with the safety of a prospective participant or their
need for treatment (i.e.,:)

- clinical needs of patient outweighs needs of research study

No exclusion criteria or any other study design elements will be used directly or
indirectly to restrict study participation by women or members of minority groups. Some
minority groups are thought to have higher OSA prevalence rates than Caucasians, so
assuming they are being screened/diagnosed at the same rates as Caucasians, the
investigators expect minority groups to be included in the study at levels equal to or
higher than the VA San Diego minority composition.