<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/NCT04501848</url>
  </required_header>
  <id_info>
    <org_study_id>NHR009417</org_study_id>
    <nct_id>NCT04501848</nct_id>
  </id_info>
  <brief_title>Parent-QoL and Sleep Disordered Breathing</brief_title>
  <official_title>The Impact of Sleep Disordered Breathing on Parental Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western Galilee Hospital-Nahariya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western Galilee Hospital-Nahariya</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In this prospective case-control study the investigators will enrolled parents of 45 children&#xD;
      younger than five years of age who were planned to undergo adenotonsillectomy due to an&#xD;
      obstructive airway indication in an academic medical center. A group of parents to healthy&#xD;
      children will comprise the control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parents of children with any chronic illness may experience increased anxiety and reduced&#xD;
      health-related quality of life (QoL).&#xD;
&#xD;
      In this study, the investigators will analyze QoL parameters among parents of obstructive&#xD;
      sleep disordered breathing (OSDB) children before and after surgical treatment.&#xD;
&#xD;
      In this prospective case-control study the investigators will enrolled parents of 45 children&#xD;
      younger than five years of age who are planned to undergo adenotonsillectomy due to an&#xD;
      obstructive airway indication in an academic medical center. A group of parents to healthy&#xD;
      children will comprisedthe control group.&#xD;
&#xD;
      The investigators will translate and validate the PAR-ENT-QoL questionnaire through&#xD;
      forward-backward translation method.&#xD;
&#xD;
      Main outcome measure: The questionnaire was tested for reliability, consistency,&#xD;
      reproducibility, responsiveness, and for its clinical use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>A change in the PAR-ENT-QoL questionnaire score</measure>
    <time_frame>Change from PAR-ENT-QoL questionnaire score, 1-3 weeks before surgery to 3-9 weeks after surgery</time_frame>
    <description>translated and validated the PAR-ENT-QoL questionnaire through forward-backward translation method.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Sleep Apnea Syndromes</condition>
  <arm_group>
    <arm_group_label>Study</arm_group_label>
    <description>parents of obstructive sleep disordered breathing (OSDB) children before and after surgical treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>A group of parents to healthy children comprised the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>adenotonsillectomy</intervention_name>
    <description>adenotonsillectomy surgery</description>
    <arm_group_label>Study</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population included parents of children younger than five years old who suffered&#xD;
        from OSDB and underwent tonsillectomy or tonsillotomy with or without adenoidectomy during&#xD;
        2018, in the Department of Otolaryngology at Galilee Medical Center, Israel.&#xD;
&#xD;
        The control group was composed of parents of healthy children of the same age group who did&#xD;
        not suffer from OSDB or any other acute or chronic disease and were recruited through an&#xD;
        online survey to complete the questionnaire&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents of children younger than five years old who suffered from OSDB and underwent&#xD;
             tonsillectomy or tonsillotomy with or without adenoidectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  We excluded parents of children who required immediate surgery or had any other&#xD;
             chronic diseases (such as ADHD, asthma, allergic rhinitis or severe medical or mental&#xD;
             impairments).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Galillee medical center</name>
      <address>
        <city>Nahariya</city>
        <zip>2210001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Berdeaux G, Hervie C, Smajda C, Marquis P. Parental quality of life and recurrent ENT infections in their children: development of a questionnaire. Rhinitis Survey Group. Qual Life Res. 1998 Aug;7(6):501-12. doi: 10.1023/a:1008874324258.</citation>
    <PMID>9737140</PMID>
  </reference>
  <reference>
    <citation>Shteinberg YH, Eisenbach N, Sela E, Gruber M, Ronen O. Translation and cultural adaptation of the Hebrew version of the Pediatric Sleep Questionnaire: a prospective, non-randomized control trial. Sleep Breath. 2021 Mar;25(1):399-410. doi: 10.1007/s11325-020-02073-6. Epub 2020 May 12.</citation>
    <PMID>32394315</PMID>
  </reference>
  <reference>
    <citation>Koller M, Aaronson NK, Blazeby J, Bottomley A, Dewolf L, Fayers P, Johnson C, Ramage J, Scott N, West K; EORTC Quality of Life Group. Translation procedures for standardised quality of life questionnaires: The European Organisation for Research and Treatment of Cancer (EORTC) approach. Eur J Cancer. 2007 Aug;43(12):1810-20. doi: 10.1016/j.ejca.2007.05.029. Epub 2007 Aug 3.</citation>
    <PMID>17689070</PMID>
  </reference>
  <reference>
    <citation>Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.</citation>
    <PMID>15804318</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Western Galilee Hospital-Nahariya</investigator_affiliation>
    <investigator_full_name>Ronen Ohad</investigator_full_name>
    <investigator_title>Director Head and Neck Surgery Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</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/NCT04501848
org study id: NHR009417
nct id: NCT04501848
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this prospective case-control study the investigators will enrolled parents of 45 children
      younger than five years of age who were planned to undergo adenotonsillectomy due to an
      obstructive airway indication in an academic medical center. A group of parents to healthy
      children will comprise the control group.
Parents of children with any chronic illness may experience increased anxiety and reduced
      health-related quality of life (QoL).

      In this study, the investigators will analyze QoL parameters among parents of obstructive
      sleep disordered breathing (OSDB) children before and after surgical treatment.

      In this prospective case-control study the investigators will enrolled parents of 45 children
      younger than five years of age who are planned to undergo adenotonsillectomy due to an
      obstructive airway indication in an academic medical center. A group of parents to healthy
      children will comprisedthe control group.

      The investigators will translate and validate the PAR-ENT-QoL questionnaire through
      forward-backward translation method.

      Main outcome measure: The questionnaire was tested for reliability, consistency,
      reproducibility, responsiveness, and for its clinical use.
observational model: Case-Control
time perspective: Prospective
measure: A change in the PAR-ENT-QoL questionnaire score
time frame: Change from PAR-ENT-QoL questionnaire score, 1-3 weeks before surgery to 3-9 weeks after surgery
description: translated and validated the PAR-ENT-QoL questionnaire through forward-backward translation method.
arm group label: Study
description: parents of obstructive sleep disordered breathing (OSDB) children before and after surgical treatment
arm group label: Control
description: A group of parents to healthy children comprised the control group.
intervention type: Procedure
intervention name: adenotonsillectomy
description: adenotonsillectomy surgery
arm group label: Study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Israel
citation: Berdeaux G, Hervie C, Smajda C, Marquis P. Parental quality of life and recurrent ENT infections in their children: development of a questionnaire. Rhinitis Survey Group. Qual Life Res. 1998 Aug;7(6):501-12. doi: 10.1023/a:1008874324258.
PMID: 9737140
citation: Shteinberg YH, Eisenbach N, Sela E, Gruber M, Ronen O. Translation and cultural adaptation of the Hebrew version of the Pediatric Sleep Questionnaire: a prospective, non-randomized control trial. Sleep Breath. 2021 Mar;25(1):399-410. doi: 10.1007/s11325-020-02073-6. Epub 2020 May 12.
PMID: 32394315
citation: Koller M, Aaronson NK, Blazeby J, Bottomley A, Dewolf L, Fayers P, Johnson C, Ramage J, Scott N, West K; EORTC Quality of Life Group. Translation procedures for standardised quality of life questionnaires: The European Organisation for Research and Treatment of Cancer (EORTC) approach. Eur J Cancer. 2007 Aug;43(12):1810-20. doi: 10.1016/j.ejca.2007.05.029. Epub 2007 Aug 3.
PMID: 17689070
citation: Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.
PMID: 15804318
responsible party type: Principal Investigator
investigator affiliation: Western Galilee Hospital-Nahariya
investigator full name: Ronen Ohad
investigator title: Director Head and Neck Surgery Unit
mesh term: Sleep Apnea Syndromes
sharing ipd: Undecided