Validating the Use of a Subjectively Reported Sleep Vital Sign

Background

The ability to identify patients with sleep disorders is recognized as increasingly important
given its association with cardiovascular disease and impact on daytime functioning and
quality of life. The Center for Disease Control recently characterized insufficient sleep as
a public health issue, while also estimating that 1 in 25 adults admit to falling asleep
while driving in a given month. 50 to 70 million Americans are affected by chronic sleep
disorders and intermittent sleep problems, yet sleep problems are under-recognized; for
example, 80 to 90% of adults with sleep disordered breathing remain undiagnosed. Sleep
disorder screening tools are available, but are often limited by the following factors:

1. Surveys may be extensive and thereby limit utilization

2. Screening tools are often targeted for specific sleep disorders (e.g. obstructive sleep
apnea (OSA)) rather than to more comprehensively screen for a wide range of sleep
disorders

3. Screening tools may not be useful in assessing outcomes during follow-up care

We propose the development of a sleep vital sign (VS) constructed as a simple-to-use survey
tool that can assist primary care in identifying patients with sleep disorders and
potentially useful to assess response to treatment. Improved identification of sleep
disorders can potentially result in a benefit to the individual patient, to the health
system, and to the greater public health.

Study Proposal We plan to investigate the use of a sleep VS (subjective patient reported
metric) as a potential tool to identify patients with sleep disorders and to measure outcomes
during follow-up care.

This pilot study is structured as a 2-arm randomized, prospective clinical trial with the
following specific aims:

1. To determine whether subjective sleep vital signs can improve the rate of identifying
patients with sleep disorders in a primary care setting.

2. To determine if subjective sleep vital signs can track patient therapy response for
various sleep disorders.

3. To correlate subjective sleep vital sign results with validated sleep measurements (e.g.
sleep surveys, Continuous Positive Airway (CPAP) usage)

Methods

This study is a 2-arm randomized clinical trial. Patients checking into Kaiser Fontana
Medical Center primary care clinics (Internal Medicine), will be randomized into one of the
following pathways: Sleep Vital Sign (VS) Pathway or Usual Care (refer to Workflow Figure).
We intend to use the first day of recruitment to identify challenges with protocol
implementation in a primary care clinic. Data collected during this day will only be used to
compare sleep VS to the other validated sleep questionnaires in the survey packet; however,
this data will not be used to compare rates of identifying sleep disorders between sleep VS
and usual care pathways.

Sleep VS Pathway When enrolling, we plan to inform the patients that we are performing a
study pertaining generally to overall well-being and quality of life, while withholding
information that the study pertains specifically to screening for sleep disorders. We believe
it is necessary to withhold information (incomplete disclosure) that the study is
specifically about sleep disorders in order to limit the risk of selection bias. If "sleep
disorders" was provided as full disclosure as the topic of the study, it may incentivize
patients with sleep problems to participate in the study (while dis-incentivizing those
without sleep problems from participating), thus introducing a potential selection bias.
Selection bias could affect the determined accuracy of the sleep VS in identifying sleep
disorders which is the primary aim of this study, and negatively affect the scientific and
educational value of this study. Furthermore, it would limit our understanding on proper
practical implementation into healthcare delivery workflows.

At check-in, a research associate will ask patients if they are interested in participating
in a research study. If patient expresses interest, the research associate will explain the
study and give an informational sheet utilizing an anticipated IRB approved script. Those who
have given verbal consent, after reviewing the information sheet, will be provided a Sleep VS
survey packet (packet includes: Sleep VS, sleep-wake assessment, ESS, FOSQ-10, and ISI).

Debriefing process: immediately after the patient completes this "Sleep VS survey packet",
the investigator will inform the patient that the purpose of this study specifically pertains
to discovering tools that may help medical providers better identify patients with sleep
disorders and will provide patient with contact for Dr. Dennis Hwang, the study's primary
investigator, in the event that the patient wishes to withdraw their data from inclusion in
study analysis.

The proposed Sleep VS is based on the following 2 questions:

1. How many days a week are you not satisfied with your sleep?

2. How many days a week is sleepiness a problem?

For the purposes of this study, the Sleep VS will be considered a positive screen if patients
response to 1) or 2) is ≥4 days. Investigators or research associates will review the Sleep
VS, and patients that screen positive will be:

1. Asked an extended set of sleep questions (refer to Triaging Algorithm Figure)

2. Brought to the attention of the primary care physician.

A triaging algorithm will be available based on answers to the extended sleep questions to
assist the primary care physician with assessment and triaging care (refer to Triaging
Algorithm Figure). Patients will primarily be triaged to sleep medicine (for OSA assessment,
complex insomnia patients, and other patients with more complex sleep disorders), to health
education 4-week cognitive behavioral therapy (CBT) program for less complex insomnia or
remain under the care of the primary care physician. If the patient is referred to sleep
medicine, the sleep VS will be performed at each sleep center appointment (it is already part
of our standard usual clinical care). The triaging algorithm is a tool to assist the primary
care physician with management suggestions, but the physician has the flexibility to manage
the patient according to best clinical judgment.

Patients that screen "negative" will not be asked the extended sleep questions nor will they
be brought to the attention of the primary care physician. They will proceed with "usual
care." If during the course of "usual care", a potential sleep disorder is discussed, the
extended sleep questions with triaging algorithm can still be utilized to assist in
determining management.

Usual Care Pathway Patients will not be provided the sleep VS packet during check-in. If
during the course of usual care, a potential sleep disorder is discussed, the extended sleep
questions with triaging algorithm can still be utilized to assist in determining management
at the discretion of the primary care physician.

Inclusion Criteria:

- Patients that have a scheduled office visit with their primary care physician.

Exclusion Criteria:

- Non-English speaking patients unable to understand English to complete the surveys.