<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/NCT03288376</url>
  </required_header>
  <id_info>
    <org_study_id>SNORE_SOUNDS</org_study_id>
    <nct_id>NCT03288376</nct_id>
  </id_info>
  <brief_title>SNORE (Smartphone Analyses of Nocturnal Obstruction by Respiratory Evaluation) SOUNDS</brief_title>
  <acronym>SNORESOUNDS</acronym>
  <official_title>SNORE (Smartphone Analyses of Nocturnal Obstruction by Respiratory Evaluation) SOUNDS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incyphae, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Incyphae, Inc.</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>
      This is a prospective multipart clinical performance study to compare the ability of the&#xD;
      SnoreSounds algorithm with polysomnography (PSG) and a type III Home Sleep Testing (HST)&#xD;
      device to identify patients with obstructive sleep apnea (OSA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consecutive patients referred to a sleep lab for possible OSA (obstructive sleep apnea) will&#xD;
      be offered participation in this study. Study subjects will participate in either Part A,&#xD;
      Part B or Part C of the study. Subjects will not participate in more than one part of the&#xD;
      study. Study sites can participate in multiple parts of the study.&#xD;
&#xD;
      Part A: Sleep Lab&#xD;
&#xD;
      Consecutive patients referred to a sleep lab for possible OSA will be offered participation.&#xD;
      Participants who provide informed consent will fill out a questionnaire and then have PSG, as&#xD;
      it would normally be performed. During PSG additional sound recordings will be made in three&#xD;
      ways:&#xD;
&#xD;
        1. Microphone placed 50-100 cm (20-40 inches) from the patient's mouth.&#xD;
&#xD;
        2. Android type Smart Phone with a recording application (app). The phone will be placed on&#xD;
           a table 50-100 cm (20-40 inches)) from patient's mouth.&#xD;
&#xD;
        3. iPhone type Smart Phone with a recording app. Phone will be placed on a table 50-100 cm&#xD;
           (20-40 inches) from patient's mouth.&#xD;
&#xD;
      The sound recordings obtained via the microphone and Smart Phones will be analyzed&#xD;
      electronically for OSA by the sponsor's proprietary algorithm. A blinded comparison will be&#xD;
      made between the PSG results and SnoreSounds algorithm results.&#xD;
&#xD;
      PSG will be performed and scored in a manner consistent with current (2012) American Academy&#xD;
      of Sleep Medicine (AASM) standards. PSGs will be scored twice - with each scoring performed&#xD;
      independently. If the Apnea Hypopnea Index (AHI) for each score places the patient in the&#xD;
      same OSA severity range [0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, &gt;30 severe] the&#xD;
      average of the two scores will be utilized. If however the scores put the patent in different&#xD;
      OSA severity ranges, then the study will be scored by an independent sleep medicine&#xD;
      physician-sleep technician team and assigned an AHI.&#xD;
&#xD;
      The results of the SnoreSounds testing will not be known to the sleep lab and the results&#xD;
      obtained from Snore Sounds analysis will not be utilized in the clinical management of study&#xD;
      participants.&#xD;
&#xD;
      Part B: Comparison of SnoreSounds algorithm to Home Sleep Testing (HST) (currently not&#xD;
      enrolling in Part B)&#xD;
&#xD;
      Part C: Comparison of SnoreSounds algorithm to Home Sleep Testing (HST) and to&#xD;
      Polysomnography (PSG) (currently not enrolling in Part C)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 13, 2015</start_date>
  <completion_date type="Actual">January 31, 2017</completion_date>
  <primary_completion_date type="Actual">January 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Agreement between algorithm with PSG reference standard for detection of OSA at an AHI cut-off of 15</measure>
    <time_frame>immediate</time_frame>
    <description>Agreement between algorithm with PSG reference standard for detection of OSA at an AHI cut-off of 15</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison between algorithm and PSG assignment of OSA severity based on AHI [0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, &gt;30 severe].</measure>
    <time_frame>immediate</time_frame>
    <description>Comparison between algorithm and PSG assignment of OSA severity based on AHI [0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, &gt;30 severe].</description>
  </secondary_outcome>
  <enrollment type="Actual">272</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Men and women aged &gt;or= 18 years who are referred for polysomnography (PSG) or Home Sleep&#xD;
        Test (HST) because of possible obstructive sleep apnea (OSA).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt;or= 18 years old who are referred for polysomnography (PSG) or Home Sleep&#xD;
             Test (HST) because of possible obstructive sleep apnea (OSA)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous PSG or HST confirming OSA&#xD;
&#xD;
          -  Prior surgery for snoring or OSA&#xD;
&#xD;
          -  Medical contraindication for PSG&#xD;
&#xD;
          -  Cognitive impairment that might interfere with obtaining informed consent or&#xD;
             completing Clinical Questionnaire&#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>Ruchir Sehra, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Incyphae, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peninsula Sleep Center</name>
      <address>
        <city>Burlingame</city>
        <state>California</state>
        <zip>94010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Medical Group</name>
      <address>
        <city>New London</city>
        <state>Connecticut</state>
        <zip>06320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doctors Community Hospital</name>
      <address>
        <city>Lanham</city>
        <state>Maryland</state>
        <zip>20706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>August 5, 2019</last_update_submitted>
  <last_update_submitted_qc>August 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obstructive sleep apnea</keyword>
  <keyword>polysomnography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03288376
org study id: SNORE_SOUNDS
nct id: NCT03288376
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective multipart clinical performance study to compare the ability of the
      SnoreSounds algorithm with polysomnography (PSG) and a type III Home Sleep Testing (HST)
      device to identify patients with obstructive sleep apnea (OSA).
Consecutive patients referred to a sleep lab for possible OSA (obstructive sleep apnea) will
      be offered participation in this study. Study subjects will participate in either Part A,
      Part B or Part C of the study. Subjects will not participate in more than one part of the
      study. Study sites can participate in multiple parts of the study.

      Part A: Sleep Lab

      Consecutive patients referred to a sleep lab for possible OSA will be offered participation.
      Participants who provide informed consent will fill out a questionnaire and then have PSG, as
      it would normally be performed. During PSG additional sound recordings will be made in three
      ways:

        1. Microphone placed 50-100 cm (20-40 inches) from the patient's mouth.

        2. Android type Smart Phone with a recording application (app). The phone will be placed on
           a table 50-100 cm (20-40 inches)) from patient's mouth.

        3. iPhone type Smart Phone with a recording app. Phone will be placed on a table 50-100 cm
           (20-40 inches) from patient's mouth.

      The sound recordings obtained via the microphone and Smart Phones will be analyzed
      electronically for OSA by the sponsor's proprietary algorithm. A blinded comparison will be
      made between the PSG results and SnoreSounds algorithm results.

      PSG will be performed and scored in a manner consistent with current (2012) American Academy
      of Sleep Medicine (AASM) standards. PSGs will be scored twice - with each scoring performed
      independently. If the Apnea Hypopnea Index (AHI) for each score places the patient in the
      same OSA severity range [0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, >30 severe] the
      average of the two scores will be utilized. If however the scores put the patent in different
      OSA severity ranges, then the study will be scored by an independent sleep medicine
      physician-sleep technician team and assigned an AHI.

      The results of the SnoreSounds testing will not be known to the sleep lab and the results
      obtained from Snore Sounds analysis will not be utilized in the clinical management of study
      participants.

      Part B: Comparison of SnoreSounds algorithm to Home Sleep Testing (HST) (currently not
      enrolling in Part B)

      Part C: Comparison of SnoreSounds algorithm to Home Sleep Testing (HST) and to
      Polysomnography (PSG) (currently not enrolling in Part C)
observational model: Case-Only
time perspective: Prospective
measure: Agreement between algorithm with PSG reference standard for detection of OSA at an AHI cut-off of 15
time frame: immediate
description: Agreement between algorithm with PSG reference standard for detection of OSA at an AHI cut-off of 15
measure: Comparison between algorithm and PSG assignment of OSA severity based on AHI [0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, >30 severe].
time frame: immediate
description: Comparison between algorithm and PSG assignment of OSA severity based on AHI [0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, >30 severe].
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ruchir Sehra, MD
role: Principal Investigator
affiliation: Incyphae, Inc.
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sleep Apnea Syndromes
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Sleep Apnea, Obstructive
sharing ipd: No