<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/NCT02204696</url>
  </required_header>
  <id_info>
    <org_study_id>HS-13-00794</org_study_id>
    <nct_id>NCT02204696</nct_id>
  </id_info>
  <brief_title>Tonsillectomy in Adults With Tonsillar Hypertrophy and Obstructive Sleep Apnea</brief_title>
  <official_title>The Role of Tonsillectomy in Adults With Marked Tonsillar Hypertrophy and Obstructive Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine if tonsillectomy eliminates symptoms of obstructive&#xD;
      sleep apnea in patients with obstructive sleep apnea and marked tonsillar hypertrophy with&#xD;
      normal soft palate and uvula length.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose: To determine if tonsillectomy eliminates symptoms of obstructive sleep apnea in&#xD;
      patients with obstructive sleep apnea and marked tonsillar hypertrophy with normal soft&#xD;
      palate and uvula length.&#xD;
&#xD;
      Specific Aims: 1. To determine if tonsillectomy eliminates obstructive sleep apnea as&#xD;
      determined by polysomnography. 2. To determine if tonsillectomy eliminates excessive daytime&#xD;
      sleepiness and other obstructive sleep apnea symptoms.&#xD;
&#xD;
      Rationale: Current surgical procedures for obstructive sleep apnea include tonsillectomy with&#xD;
      soft palate surgery (including uvulopalatopharyngoplasty). Tonsillectomy alone may provide&#xD;
      sufficient benefit in adults with marked tonsillar hypertrophy and normal soft palate and&#xD;
      uvula length, avoiding the need for additional soft palate surgery.&#xD;
&#xD;
      Intervention: Tonsillectomy will be performed as standard of care, in patients who would be&#xD;
      undergoing said surgery regardless of study. Study intervention includes multiple home sleep&#xD;
      studies to determine effect of tonsillectomy in impacting symptoms of sleep apnea.&#xD;
&#xD;
      Study Population: Inclusion criteria: Subjects must be at least 18 years old, have documented&#xD;
      obstructive sleep apnea; be willing to undergo 3 home sleep studies; and have markedly&#xD;
      hypertrophic (3+ or 4+) tonsils. Exclusion criteria: Subjects must not have any craniofacial&#xD;
      abnormality; normal soft palate length (&lt;4 cm) and uvula length ((&lt;2 cm); must have no&#xD;
      history of chronic obstructive pulmonary disease, untreated psychological disorder, restless&#xD;
      leg syndrome, alcohol or drug abuse; must have a body mass index &lt;35; must not plan to use&#xD;
      continuous positive airway pressure during the study period, and lack significant nasal&#xD;
      obstruction. The subjects will serve as their own control.&#xD;
&#xD;
      Methods and Follow Up: This two-center prospective study will include evaluation of&#xD;
      demographics, clinical symptoms, extent of tonsillar hypertrophy, sleep habits, and home&#xD;
      sleep studies. All subjects will undergo a 4-8 week period of watchful waiting (standard&#xD;
      minimum delay for scheduling surgery), followed by tonsillectomy alone, with values at&#xD;
      baseline compared to a period of watchful waiting and post-tonsillectomy.&#xD;
&#xD;
      Outcomes: Primary outcome is apnea-hypopnea index (from home sleep study). Exploratory&#xD;
      outcomes include other sleep study results and subjective assessments (sleep-related quality&#xD;
      of life with the Functional Outcome of Sleep Questionnaire and daytime sleepiness with the&#xD;
      Epworth Sleepiness Scale).&#xD;
&#xD;
      Statistics and Plans for Analysis: The minimum sample size is 44 subjects, with an enrollment&#xD;
      target of 60 subjects that will accommodate a 25% dropout rate. Standard statistical tests&#xD;
      (e.g., paired t-tests for continuous measures) will evaluate potential differences between&#xD;
      outcome measures at baseline vs. post-watchful waiting and baseline vs. post-tonsillectomy.&#xD;
      Similarly, standard and appropriate statistical tests (e.g, t-tests for continuous measures)&#xD;
      will compare changes with watchful waiting vs. tonsillectomy (e.g., baseline vs.&#xD;
      post-watchful against baseline vs. post-tonsillectomy).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants enrolled&#xD;
  </why_stopped>
  <start_date>December 2010</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>apnea-hypopnea index</measure>
    <time_frame>8 weeks</time_frame>
    <description>This will be determined by home sleep study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale score</measure>
    <time_frame>8 weeks</time_frame>
    <description>This measure of daytime sleepiness will be assessed by questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Outcomes of Sleep Questionnaire score</measure>
    <time_frame>8 weeks</time_frame>
    <description>This measure of sleep-related quality of life will be assessed by questionnaire.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Insomnia Severity Index</measure>
    <time_frame>8 weeks</time_frame>
    <description>This measure of insomnia severity will be assessed by questionnaire.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Tonsillectomy</arm_group_label>
    <description>All participants will undergo baseline sleep study, a second preoperative sleep study after a period of watchful waiting, and a postoperative sleep study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tonsillectomy</intervention_name>
    <description>Study participants will be scheduled for tonsillectomy based on clinical indications, with the need for surgery determined prior to study enrollment and not based on study enrollment.</description>
    <arm_group_label>Tonsillectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with obstructive sleep apnea and tonsillar hypertrophy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Documented obstructive sleep apnea (with central apneas of the total number of apneas&#xD;
             plus hypopneas)&#xD;
&#xD;
          -  Able to complete all forms in English and follow-up appointments&#xD;
&#xD;
          -  Willing to undergo 3 home sleep studies; and markedly hypertrophic (3+ or 4+) tonsils&#xD;
&#xD;
          -  Tonsil size of 3+ or 4+ corresponds to tonsils that occupy more than 50% of the space&#xD;
             between the tonsillar fossa (side of the throat) and midline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No craniofacial abnormality&#xD;
&#xD;
          -  No history of COPD, untreated psychological disorder, other sleep disorder, alcohol or&#xD;
             drug abuse&#xD;
&#xD;
          -  Body mass index &lt;35 kg/m2&#xD;
&#xD;
          -  Unable to tolerate other treatments for obstructive sleep apnea&#xD;
&#xD;
          -  Soft palate length &gt; 4 cm&#xD;
&#xD;
          -  Uvula length &gt; 2 cm&#xD;
&#xD;
          -  No significant nasal obstruction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Keck Hospital of USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Eric Kezirian</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>sleep apnea</keyword>
  <keyword>obstructive sleep apnea</keyword>
  <keyword>sleepiness</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Hypertrophy</mesh_term>
  </condition_browse>
  <!-- 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/NCT02204696
org study id: HS-13-00794
nct id: NCT02204696
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to determine if tonsillectomy eliminates symptoms of obstructive
      sleep apnea in patients with obstructive sleep apnea and marked tonsillar hypertrophy with
      normal soft palate and uvula length.
Purpose: To determine if tonsillectomy eliminates symptoms of obstructive sleep apnea in
      patients with obstructive sleep apnea and marked tonsillar hypertrophy with normal soft
      palate and uvula length.

      Specific Aims: 1. To determine if tonsillectomy eliminates obstructive sleep apnea as
      determined by polysomnography. 2. To determine if tonsillectomy eliminates excessive daytime
      sleepiness and other obstructive sleep apnea symptoms.

      Rationale: Current surgical procedures for obstructive sleep apnea include tonsillectomy with
      soft palate surgery (including uvulopalatopharyngoplasty). Tonsillectomy alone may provide
      sufficient benefit in adults with marked tonsillar hypertrophy and normal soft palate and
      uvula length, avoiding the need for additional soft palate surgery.

      Intervention: Tonsillectomy will be performed as standard of care, in patients who would be
      undergoing said surgery regardless of study. Study intervention includes multiple home sleep
      studies to determine effect of tonsillectomy in impacting symptoms of sleep apnea.

      Study Population: Inclusion criteria: Subjects must be at least 18 years old, have documented
      obstructive sleep apnea; be willing to undergo 3 home sleep studies; and have markedly
      hypertrophic (3+ or 4+) tonsils. Exclusion criteria: Subjects must not have any craniofacial
      abnormality; normal soft palate length (<4 cm) and uvula length ((<2 cm); must have no
      history of chronic obstructive pulmonary disease, untreated psychological disorder, restless
      leg syndrome, alcohol or drug abuse; must have a body mass index <35; must not plan to use
      continuous positive airway pressure during the study period, and lack significant nasal
      obstruction. The subjects will serve as their own control.

      Methods and Follow Up: This two-center prospective study will include evaluation of
      demographics, clinical symptoms, extent of tonsillar hypertrophy, sleep habits, and home
      sleep studies. All subjects will undergo a 4-8 week period of watchful waiting (standard
      minimum delay for scheduling surgery), followed by tonsillectomy alone, with values at
      baseline compared to a period of watchful waiting and post-tonsillectomy.

      Outcomes: Primary outcome is apnea-hypopnea index (from home sleep study). Exploratory
      outcomes include other sleep study results and subjective assessments (sleep-related quality
      of life with the Functional Outcome of Sleep Questionnaire and daytime sleepiness with the
      Epworth Sleepiness Scale).

      Statistics and Plans for Analysis: The minimum sample size is 44 subjects, with an enrollment
      target of 60 subjects that will accommodate a 25% dropout rate. Standard statistical tests
      (e.g., paired t-tests for continuous measures) will evaluate potential differences between
      outcome measures at baseline vs. post-watchful waiting and baseline vs. post-tonsillectomy.
      Similarly, standard and appropriate statistical tests (e.g, t-tests for continuous measures)
      will compare changes with watchful waiting vs. tonsillectomy (e.g., baseline vs.
      post-watchful against baseline vs. post-tonsillectomy).
observational model: Cohort
time perspective: Prospective
measure: apnea-hypopnea index
time frame: 8 weeks
description: This will be determined by home sleep study.
measure: Epworth Sleepiness Scale score
time frame: 8 weeks
description: This measure of daytime sleepiness will be assessed by questionnaire.
measure: Functional Outcomes of Sleep Questionnaire score
time frame: 8 weeks
description: This measure of sleep-related quality of life will be assessed by questionnaire.
measure: Insomnia Severity Index
time frame: 8 weeks
description: This measure of insomnia severity will be assessed by questionnaire.
arm group label: Tonsillectomy
description: All participants will undergo baseline sleep study, a second preoperative sleep study after a period of watchful waiting, and a postoperative sleep study.
intervention type: Procedure
intervention name: Tonsillectomy
description: Study participants will be scheduled for tonsillectomy based on clinical indications, with the need for surgery determined prior to study enrollment and not based on study enrollment.
arm group label: Tonsillectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Eric Kezirian
investigator title: Professor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Hypertrophy