<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/NCT03264963</url>
  </required_header>
  <id_info>
    <org_study_id>1606S88671</org_study_id>
    <nct_id>NCT03264963</nct_id>
  </id_info>
  <brief_title>Upper Airway Training for Treatment of Snoring</brief_title>
  <official_title>Upper Airway Training for Treatment of Snoring Using Smartphone Application</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UMN Medical Devices Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fairview Sleep Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</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>
      The objective of this study is to reduce the incidence or intensity of snoring in a patient&#xD;
      population of known simple snorers without sleep apnea using smartphone based application&#xD;
      which allows participants to play voice controlled games using various articulations&#xD;
      resulting in tongue base movements.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2016</start_date>
  <completion_date type="Actual">May 18, 2017</completion_date>
  <primary_completion_date type="Actual">April 15, 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Snoring Intensity</measure>
    <time_frame>12 weeks</time_frame>
    <description>Snoring sounds &gt;60 db</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Snoring Rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>Snoring sounds/hour of sleep</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>12 weeks</time_frame>
    <description>Self reported sleep quality on likert scale (0 to 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bed Partner Sleep Quality</measure>
    <time_frame>12 weeks</time_frame>
    <description>Bed partner reported sleep quality on likert scale (0 to 5)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleepiness</measure>
    <time_frame>12 weeks</time_frame>
    <description>Epworth sleepiness score</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Snoring</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Smart phone game play</intervention_name>
    <description>Voice controlled smart phone game play 15 minutes daily and recording sounds of sleep environment 2 night per week for 12 weeks</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Recording of sleep environment 2 nights per week for 12 weeks</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Fluent in English.&#xD;
&#xD;
          2. Age is between 20 and 65.&#xD;
&#xD;
          3. BMI less than 32&#xD;
&#xD;
          4. Less than 5% variance in weight since sleep study.&#xD;
&#xD;
          5. Snoring without health risk related to sleep apnea and not currently receiving&#xD;
             treatment.&#xD;
&#xD;
               1. Mild OSA or negative HSAT or PSG within past year with AHI 0-14&#xD;
&#xD;
               2. Has refused oral appliances, CPAP, weight loss, surgery or positional therapy.&#xD;
&#xD;
          6. Owns an iPhone 4 or newer and is comfortable downloading and using apps.&#xD;
&#xD;
          7. Complaint of habitual snoring 3 or more nights per week&#xD;
&#xD;
          8. Rated by polysomnograph technologist as moderate or loud snoring.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non-fluent in English.&#xD;
&#xD;
          2. Persistent rhinitis diagnosis or nasal obstruction.&#xD;
&#xD;
          3. BMI &gt; 32&#xD;
&#xD;
          4. Greater than 5% variance in weight since sleep study.&#xD;
&#xD;
          5. Diagnosis of moderate to severe sleep apnea or any other sleep disorder (insomnia,&#xD;
             RLS)&#xD;
&#xD;
          6. Insufficient sleep, defined as getting fewer than 6 hours of sleep on an average night&#xD;
             based on self report.&#xD;
&#xD;
          7. Spouse/partner is also a habitual snorer.&#xD;
&#xD;
          8. Lacking ability to consent for themselves.&#xD;
&#xD;
          9. Heavy drinker (self reported average more than 2 drinks per day).&#xD;
&#xD;
         10. Regular narcotics (greater than 3 times/week)&#xD;
&#xD;
         11. Epworth sleepiness scale score &gt; 11 or one near miss accident in the past 6 months.&#xD;
&#xD;
         12. Medical conditions as follows: symptomatic cardiopulmonary disease, chronic renal&#xD;
             insufficiency, poorly controlled mental illness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>November 6, 2017</last_update_submitted>
  <last_update_submitted_qc>November 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Upper airway exercises</keyword>
  <keyword>Smart phone application</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Snoring</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03264963
org study id: 1606S88671
nct id: NCT03264963
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to reduce the incidence or intensity of snoring in a patient
      population of known simple snorers without sleep apnea using smartphone based application
      which allows participants to play voice controlled games using various articulations
      resulting in tongue base movements.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Snoring Intensity
time frame: 12 weeks
description: Snoring sounds >60 db
measure: Snoring Rate
time frame: 12 weeks
description: Snoring sounds/hour of sleep
measure: Sleep Quality
time frame: 12 weeks
description: Self reported sleep quality on likert scale (0 to 5)
measure: Bed Partner Sleep Quality
time frame: 12 weeks
description: Bed partner reported sleep quality on likert scale (0 to 5)
measure: Sleepiness
time frame: 12 weeks
description: Epworth sleepiness score
arm group label: Control
arm group type: Active Comparator
arm group label: Intervention
arm group type: Experimental
intervention type: Other
intervention name: Smart phone game play
description: Voice controlled smart phone game play 15 minutes daily and recording sounds of sleep environment 2 night per week for 12 weeks
arm group label: Intervention
intervention type: Other
intervention name: Control
description: Recording of sleep environment 2 nights per week for 12 weeks
arm group label: Control
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Snoring
sharing ipd: Undecided