<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03018912</url>
  </required_header>
  <id_info>
    <org_study_id>KPSleep-002</org_study_id>
    <nct_id>NCT03018912</nct_id>
  </id_info>
  <brief_title>Validating the Use of a Subjectively Reported Sleep Vital Sign</brief_title>
  <acronym>SSVS</acronym>
  <official_title>Validating the Use of a Novel Subjectively Reported Sleep Vital Sign for the Identification and Management of Sleep Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaiser Permanente</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sleep disorders are commonly under-recognized in the primary care setting and available&#xD;
      screening tools are often are limited. The study inestigators hypothesize that the use of a&#xD;
      novel subjective sleep vital sign (VS) will improve recognition of patients with sleep&#xD;
      disorders and can be utilized to track outcomes to sleep therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      The ability to identify patients with sleep disorders is recognized as increasingly important&#xD;
      given its association with cardiovascular disease and impact on daytime functioning and&#xD;
      quality of life. The Center for Disease Control recently characterized insufficient sleep as&#xD;
      a public health issue, while also estimating that 1 in 25 adults admit to falling asleep&#xD;
      while driving in a given month. 50 to 70 million Americans are affected by chronic sleep&#xD;
      disorders and intermittent sleep problems, yet sleep problems are under-recognized; for&#xD;
      example, 80 to 90% of adults with sleep disordered breathing remain undiagnosed. Sleep&#xD;
      disorder screening tools are available, but are often limited by the following factors:&#xD;
&#xD;
        1. Surveys may be extensive and thereby limit utilization&#xD;
&#xD;
        2. Screening tools are often targeted for specific sleep disorders (e.g. obstructive sleep&#xD;
           apnea (OSA)) rather than to more comprehensively screen for a wide range of sleep&#xD;
           disorders&#xD;
&#xD;
        3. Screening tools may not be useful in assessing outcomes during follow-up care&#xD;
&#xD;
      We propose the development of a sleep vital sign (VS) constructed as a simple-to-use survey&#xD;
      tool that can assist primary care in identifying patients with sleep disorders and&#xD;
      potentially useful to assess response to treatment. Improved identification of sleep&#xD;
      disorders can potentially result in a benefit to the individual patient, to the health&#xD;
      system, and to the greater public health.&#xD;
&#xD;
      Study Proposal We plan to investigate the use of a sleep VS (subjective patient reported&#xD;
      metric) as a potential tool to identify patients with sleep disorders and to measure outcomes&#xD;
      during follow-up care.&#xD;
&#xD;
      This pilot study is structured as a 2-arm randomized, prospective clinical trial with the&#xD;
      following specific aims:&#xD;
&#xD;
        1. To determine whether subjective sleep vital signs can improve the rate of identifying&#xD;
           patients with sleep disorders in a primary care setting.&#xD;
&#xD;
        2. To determine if subjective sleep vital signs can track patient therapy response for&#xD;
           various sleep disorders.&#xD;
&#xD;
        3. To correlate subjective sleep vital sign results with validated sleep measurements (e.g.&#xD;
           sleep surveys, Continuous Positive Airway (CPAP) usage)&#xD;
&#xD;
      Methods&#xD;
&#xD;
      This study is a 2-arm randomized clinical trial. Patients checking into Kaiser Fontana&#xD;
      Medical Center primary care clinics (Internal Medicine), will be randomized into one of the&#xD;
      following pathways: Sleep Vital Sign (VS) Pathway or Usual Care (refer to Workflow Figure).&#xD;
      We intend to use the first day of recruitment to identify challenges with protocol&#xD;
      implementation in a primary care clinic. Data collected during this day will only be used to&#xD;
      compare sleep VS to the other validated sleep questionnaires in the survey packet; however,&#xD;
      this data will not be used to compare rates of identifying sleep disorders between sleep VS&#xD;
      and usual care pathways.&#xD;
&#xD;
      Sleep VS Pathway When enrolling, we plan to inform the patients that we are performing a&#xD;
      study pertaining generally to overall well-being and quality of life, while withholding&#xD;
      information that the study pertains specifically to screening for sleep disorders. We believe&#xD;
      it is necessary to withhold information (incomplete disclosure) that the study is&#xD;
      specifically about sleep disorders in order to limit the risk of selection bias. If &quot;sleep&#xD;
      disorders&quot; was provided as full disclosure as the topic of the study, it may incentivize&#xD;
      patients with sleep problems to participate in the study (while dis-incentivizing those&#xD;
      without sleep problems from participating), thus introducing a potential selection bias.&#xD;
      Selection bias could affect the determined accuracy of the sleep VS in identifying sleep&#xD;
      disorders which is the primary aim of this study, and negatively affect the scientific and&#xD;
      educational value of this study. Furthermore, it would limit our understanding on proper&#xD;
      practical implementation into healthcare delivery workflows.&#xD;
&#xD;
      At check-in, a research associate will ask patients if they are interested in participating&#xD;
      in a research study. If patient expresses interest, the research associate will explain the&#xD;
      study and give an informational sheet utilizing an anticipated IRB approved script. Those who&#xD;
      have given verbal consent, after reviewing the information sheet, will be provided a Sleep VS&#xD;
      survey packet (packet includes: Sleep VS, sleep-wake assessment, ESS, FOSQ-10, and ISI).&#xD;
&#xD;
      Debriefing process: immediately after the patient completes this &quot;Sleep VS survey packet&quot;,&#xD;
      the investigator will inform the patient that the purpose of this study specifically pertains&#xD;
      to discovering tools that may help medical providers better identify patients with sleep&#xD;
      disorders and will provide patient with contact for Dr. Dennis Hwang, the study's primary&#xD;
      investigator, in the event that the patient wishes to withdraw their data from inclusion in&#xD;
      study analysis.&#xD;
&#xD;
      The proposed Sleep VS is based on the following 2 questions:&#xD;
&#xD;
        1. How many days a week are you not satisfied with your sleep?&#xD;
&#xD;
        2. How many days a week is sleepiness a problem?&#xD;
&#xD;
      For the purposes of this study, the Sleep VS will be considered a positive screen if patients&#xD;
      response to 1) or 2) is ≥4 days. Investigators or research associates will review the Sleep&#xD;
      VS, and patients that screen positive will be:&#xD;
&#xD;
        1. Asked an extended set of sleep questions (refer to Triaging Algorithm Figure)&#xD;
&#xD;
        2. Brought to the attention of the primary care physician.&#xD;
&#xD;
      A triaging algorithm will be available based on answers to the extended sleep questions to&#xD;
      assist the primary care physician with assessment and triaging care (refer to Triaging&#xD;
      Algorithm Figure). Patients will primarily be triaged to sleep medicine (for OSA assessment,&#xD;
      complex insomnia patients, and other patients with more complex sleep disorders), to health&#xD;
      education 4-week cognitive behavioral therapy (CBT) program for less complex insomnia or&#xD;
      remain under the care of the primary care physician. If the patient is referred to sleep&#xD;
      medicine, the sleep VS will be performed at each sleep center appointment (it is already part&#xD;
      of our standard usual clinical care). The triaging algorithm is a tool to assist the primary&#xD;
      care physician with management suggestions, but the physician has the flexibility to manage&#xD;
      the patient according to best clinical judgment.&#xD;
&#xD;
      Patients that screen &quot;negative&quot; will not be asked the extended sleep questions nor will they&#xD;
      be brought to the attention of the primary care physician. They will proceed with &quot;usual&#xD;
      care.&quot; If during the course of &quot;usual care&quot;, a potential sleep disorder is discussed, the&#xD;
      extended sleep questions with triaging algorithm can still be utilized to assist in&#xD;
      determining management.&#xD;
&#xD;
      Usual Care Pathway Patients will not be provided the sleep VS packet during check-in. If&#xD;
      during the course of usual care, a potential sleep disorder is discussed, the extended sleep&#xD;
      questions with triaging algorithm can still be utilized to assist in determining management&#xD;
      at the discretion of the primary care physician.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 22, 2018</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep Disorder Identification Rates</measure>
    <time_frame>3 months</time_frame>
    <description>Compare the rate of identification of sleep disorders between each pathway</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Referral Rates</measure>
    <time_frame>3 months</time_frame>
    <description>Compare the rate of referrals to sleep medicine, health education, and/or other departments for sleep disorders between each pathway</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep VS vs Sleep Questionnaires</measure>
    <time_frame>Every time patient completes the Sleep VS survey packet over a 3 month period.</time_frame>
    <description>Compare the Sleep VS results with the other establish sleep questionnaires (ESS, FOSQ-10, and ISI) between the Active and Non-Active pathways</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing response to treatment using Sleep VS</measure>
    <time_frame>Every time patient completes the Sleep VS survey packet over a 3 month period.</time_frame>
    <description>Compare Sleep VS at baseline and during follow-up care between the Active and Non-Active pathways, and correlating such assessments with sleep diagnosis and therapy provided.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medications and Encounters</measure>
    <time_frame>3 months</time_frame>
    <description>Compare the use of sleep/psychiatric medications and healthcare encounters.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Obstructive Sleep Apnea (OSA)</condition>
  <condition>Insomnia</condition>
  <condition>Restless Leg Syndrome (RLS)</condition>
  <condition>Hypersomnia Type; Sleep Disorder</condition>
  <condition>Shift Work Sleep Disorders</condition>
  <arm_group>
    <arm_group_label>Sleep VS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients check-in for their primary care physician visit and are provided a Sleep VS survey packet. Investigators or research associates will review the Sleep VS, and patients that screen positive on their Sleep VS will be asked to complete an extended set of sleep questions. 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. Patients that screen &quot;negative&quot; will not be asked the extended sleep questions nor will they be brought to the attention of the primary care physician and proceed with &quot;usual care.&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients check-in for their primary care physician visit and proceed with &quot;usual care&quot;. Although the sleep vital sign will not be collected, the medical providers can still use the extended sleep questionnaire and triaging algorithm, if in the course of caring of the patient a potential sleep disorder is recognized.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sleep VS</intervention_name>
    <description>During check in patients are instructed to complete the Sleep VS survey packet only. The Sleep VS survey packet will take approximately 4 minutes to complete. The packet includes the subjective Sleep VS and additional sleep questionnaires, such as ESS, FOSQ-10, ISI, and sleep-wake pattern questions.&#xD;
The subjective Sleep VS is composed of the following 2 questions:&#xD;
How many days a week are you satisfied with your sleep?&#xD;
How many days a week is sleepiness a problem?</description>
    <arm_group_label>Sleep VS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients that have a scheduled office visit with their primary care physician.&#xD;
&#xD;
          -  Patients have to be Kaiser Permanente members&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking patients unable to understand English to complete the surveys.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis Hwang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaiser Permanente</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sleep Center; Fontana Medical Center, Kaiser Permanente</name>
      <address>
        <city>Fontana</city>
        <state>California</state>
        <zip>92335</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.cdc.gov/features/dssleep/</url>
    <description>&quot;Insufficient Sleep is a Public Health Problem.&quot;</description>
  </link>
  <link>
    <url>http://www.cdc.gov/features/dsdrowsydriving/</url>
    <description>&quot;Drowsy Driving: Asleep at the Wheel.&quot;</description>
  </link>
  <reference>
    <citation>Institute of Medicine (US) Committee on Sleep Medicine and Research; Colten HR, Altevogt BM, editors. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. Washington (DC): National Academies Press (US); 2006. Available from http://www.ncbi.nlm.nih.gov/books/NBK19960/</citation>
    <PMID>20669438</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 1, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>July 5, 2022</last_update_submitted>
  <last_update_submitted_qc>July 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kaiser Permanente</investigator_affiliation>
    <investigator_full_name>Dennis Hwang, MD</investigator_full_name>
    <investigator_title>Department Medical Director</investigator_title>
  </responsible_party>
  <keyword>Subjective Sleep Vital Sign (VS)</keyword>
  <keyword>Primary Care</keyword>
  <keyword>Sleep Medicine</keyword>
  <keyword>Cognitive Behavioral Therapy (CBT)</keyword>
  <keyword>Obstructive Sleep Apnea (OSA)</keyword>
  <keyword>Insomnia</keyword>
  <keyword>Complex Sleep Disorders</keyword>
  <keyword>Predictive Analytics</keyword>
  <keyword>Screening</keyword>
  <keyword>Therapy Outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Restless Legs Syndrome</mesh_term>
    <mesh_term>Disorders of Excessive Somnolence</mesh_term>
    <mesh_term>Sleep Disorders, Circadian Rhythm</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This study will be conducted solely within Kaiser Permanente, and it is unnecessary to release IPD to external sources or organizations.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03018912
org study id: KPSleep-002
nct id: NCT03018912
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sleep disorders are commonly under-recognized in the primary care setting and available
      screening tools are often are limited. The study inestigators hypothesize that the use of a
      novel subjective sleep vital sign (VS) will improve recognition of patients with sleep
      disorders and can be utilized to track outcomes to sleep therapy.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Sleep Disorder Identification Rates
time frame: 3 months
description: Compare the rate of identification of sleep disorders between each pathway
measure: Referral Rates
time frame: 3 months
description: Compare the rate of referrals to sleep medicine, health education, and/or other departments for sleep disorders between each pathway
measure: Sleep VS vs Sleep Questionnaires
time frame: Every time patient completes the Sleep VS survey packet over a 3 month period.
description: Compare the Sleep VS results with the other establish sleep questionnaires (ESS, FOSQ-10, and ISI) between the Active and Non-Active pathways
measure: Assessing response to treatment using Sleep VS
time frame: Every time patient completes the Sleep VS survey packet over a 3 month period.
description: Compare Sleep VS at baseline and during follow-up care between the Active and Non-Active pathways, and correlating such assessments with sleep diagnosis and therapy provided.
measure: Medications and Encounters
time frame: 3 months
description: Compare the use of sleep/psychiatric medications and healthcare encounters.
arm group label: Sleep VS
arm group type: Experimental
description: Patients check-in for their primary care physician visit and are provided a Sleep VS survey packet. Investigators or research associates will review the Sleep VS, and patients that screen positive on their Sleep VS will be asked to complete an extended set of sleep questions. 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. 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 and proceed with "usual care."
arm group label: Usual Care
arm group type: No Intervention
description: Patients check-in for their primary care physician visit and proceed with "usual care". Although the sleep vital sign will not be collected, the medical providers can still use the extended sleep questionnaire and triaging algorithm, if in the course of caring of the patient a potential sleep disorder is recognized.
intervention type: Other
intervention name: Sleep VS
description: During check in patients are instructed to complete the Sleep VS survey packet only. The Sleep VS survey packet will take approximately 4 minutes to complete. The packet includes the subjective Sleep VS and additional sleep questionnaires, such as ESS, FOSQ-10, ISI, and sleep-wake pattern questions.
The subjective Sleep VS is composed of the following 2 questions:
How many days a week are you satisfied with your sleep?
How many days a week is sleepiness a problem?
arm group label: Sleep VS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dennis Hwang, MD
role: Principal Investigator
affiliation: Kaiser Permanente
facility: 
country: United States
url: http://www.cdc.gov/features/dssleep/
description: "Insufficient Sleep is a Public Health Problem."
url: http://www.cdc.gov/features/dsdrowsydriving/
description: "Drowsy Driving: Asleep at the Wheel."
citation: Institute of Medicine (US) Committee on Sleep Medicine and Research; Colten HR, Altevogt BM, editors. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. Washington (DC): National Academies Press (US); 2006. Available from http://www.ncbi.nlm.nih.gov/books/NBK19960/
PMID: 20669438
responsible party type: Principal Investigator
investigator affiliation: Kaiser Permanente
investigator full name: Dennis Hwang, MD
investigator title: Department Medical Director
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Restless Legs Syndrome
mesh term: Disorders of Excessive Somnolence
mesh term: Sleep Disorders, Circadian Rhythm
sharing ipd: No
ipd description: This study will be conducted solely within Kaiser Permanente, and it is unnecessary to release IPD to external sources or organizations.