<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/NCT03776773</url>
  </required_header>
  <id_info>
    <org_study_id>38RC18.264</org_study_id>
    <nct_id>NCT03776773</nct_id>
  </id_info>
  <brief_title>Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study</brief_title>
  <acronym>POLLAR</acronym>
  <official_title>Impact of Pollution on Allergic Rhinitis and Sleep Quality: the POLLAR Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</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>
      It has been demonstrated that allergic rhinitis (AR) reduces sleep quality by some components&#xD;
      such as nasal obstruction. Pollution and allergen exposure worsening AR, sleep quality is&#xD;
      deteriorated.&#xD;
&#xD;
      Sleep is associated to physical and mental health, alterations in sleep could explain the&#xD;
      link between AR and work productivity diminution, impairment in daily activities or emotional&#xD;
      problems.&#xD;
&#xD;
      However, interactions between air pollution, sleep and allergic diseases are insufficiently&#xD;
      understood.&#xD;
&#xD;
      The main objective of this study is to determine the impact of pollution and pollens on sleep&#xD;
      parameters.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over 150 million people have allergic rhinitis (AR) in Europe and around 30% have&#xD;
      uncontrolled AR during allergen exposure. It has been demonstrated that AR reduces sleep&#xD;
      quality by some components such as nasal obstruction. Pollution and allergen exposure&#xD;
      worsening AR, sleep quality is deteriorated.&#xD;
&#xD;
      Sleep is associated to physical and mental health, alterations in sleep could explain the&#xD;
      link between AR and work productivity diminution, impairment in daily activities or emotional&#xD;
      problems.&#xD;
&#xD;
      However, interactions between air pollution, sleep and allergic diseases are insufficiently&#xD;
      understood.&#xD;
&#xD;
      Moreover, the prevalence of OSA in patients with AR is higher than in subjects without AR.&#xD;
      Nasal obstruction could explain the increased risk of OSA.&#xD;
&#xD;
      This prospective, open study will compare sleep quality in 2 different groups: AR patients&#xD;
      and patients without AR during the pollen season and outside the pollen season.The main&#xD;
      objective is to determine the impact of pollution and pollens on sleep parameters for&#xD;
      subjects with AR&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 8, 2019</start_date>
  <completion_date type="Actual">January 25, 2020</completion_date>
  <primary_completion_date type="Actual">January 25, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective, open study comparing sleep quality in 2 different groups: AR patients and patients without AR during the pollen season and outside the pollen season.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of pollution on sleep</measure>
    <time_frame>6 days</time_frame>
    <description>Change in AHI according to the level of pollution particle matters and volatile organic compounds (VOCs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The impact of pollution and pollens on sleep quality in patients with AR.</measure>
    <time_frame>6 days</time_frame>
    <description>Change in Pittsburgh score according to the level of pollution particle matters and volatile organic compounds (VOCs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The impact of pollution on life quality</measure>
    <time_frame>6 days</time_frame>
    <description>Change in EQ-5D score according to the level of pollution particle matters and volatile organic compounds (VOCs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To analyze variations in medications and impact on sleep during the pollen season and outside the pollen season.</measure>
    <time_frame>6 days</time_frame>
    <description>Change in number of medications (antiallergics and hypnotics) according to the level of pollution particle matters and volatile organic compounds (VOCs)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Sleep Apnea</condition>
  <condition>Allergic Rhinitis</condition>
  <condition>Allergic Asthma</condition>
  <condition>Pollution Exposure</condition>
  <condition>Pollution Related Respiratory Disorder</condition>
  <arm_group>
    <arm_group_label>patients AR (+) and sleep apnea (+)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with AR and obstructive sleep apnea (OSA) will have sleep and pollution exposure recordings</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AR (-) and sleep apnea (+)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients without allergic rhinitis (+ sleep apnea) will have sleep and pollution exposure recordings</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AR (+) and sleep apnea (-)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with allergic rhinitis but no sleep apnea will have sleep and pollution exposure recordings</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AR (-) and sleep apnea (-)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Volunteers without allergic rhinitis and no sleep apnea will have sleep and pollution exposure recordings</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pollution exposure</intervention_name>
    <description>Pollution exposure and sleep data will be recorded by pollution sensor and polysomnography respectively. In order to compare the variations according to the pollinisation season and the allergic rhinitis status of the patients.</description>
    <arm_group_label>AR (+) and sleep apnea (-)</arm_group_label>
    <arm_group_label>AR (-) and sleep apnea (+)</arm_group_label>
    <arm_group_label>AR (-) and sleep apnea (-)</arm_group_label>
    <arm_group_label>patients AR (+) and sleep apnea (+)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years&#xD;
&#xD;
          -  Be able to use an application on a personal smartphone&#xD;
&#xD;
          -  Patient non treated for OSA&#xD;
&#xD;
          -  Be legally able to give consent&#xD;
&#xD;
          -  Person affiliated to social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Being unable to understand, follow objectives and methods due to cognition or language&#xD;
        problems Subjects listed in articles L1121-5 à L1121-8: Pregnant women, feeding and&#xD;
        parturient; subject under administrative or judicial control, persons who are protected&#xD;
        under the act.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Louis PEPIN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>March 12, 2020</last_update_submitted>
  <last_update_submitted_qc>March 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rhinitis</mesh_term>
    <mesh_term>Rhinitis, Allergic</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
    <mesh_term>Respiratory Tract Diseases</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/NCT03776773
org study id: 38RC18.264
nct id: NCT03776773
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It has been demonstrated that allergic rhinitis (AR) reduces sleep quality by some components
      such as nasal obstruction. Pollution and allergen exposure worsening AR, sleep quality is
      deteriorated.

      Sleep is associated to physical and mental health, alterations in sleep could explain the
      link between AR and work productivity diminution, impairment in daily activities or emotional
      problems.

      However, interactions between air pollution, sleep and allergic diseases are insufficiently
      understood.

      The main objective of this study is to determine the impact of pollution and pollens on sleep
      parameters.
Over 150 million people have allergic rhinitis (AR) in Europe and around 30% have
      uncontrolled AR during allergen exposure. It has been demonstrated that AR reduces sleep
      quality by some components such as nasal obstruction. Pollution and allergen exposure
      worsening AR, sleep quality is deteriorated.

      Sleep is associated to physical and mental health, alterations in sleep could explain the
      link between AR and work productivity diminution, impairment in daily activities or emotional
      problems.

      However, interactions between air pollution, sleep and allergic diseases are insufficiently
      understood.

      Moreover, the prevalence of OSA in patients with AR is higher than in subjects without AR.
      Nasal obstruction could explain the increased risk of OSA.

      This prospective, open study will compare sleep quality in 2 different groups: AR patients
      and patients without AR during the pollen season and outside the pollen season.The main
      objective is to determine the impact of pollution and pollens on sleep parameters for
      subjects with AR
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Prospective, open study comparing sleep quality in 2 different groups: AR patients and patients without AR during the pollen season and outside the pollen season.
primary purpose: Other
masking: None (Open Label)
measure: Impact of pollution on sleep
time frame: 6 days
description: Change in AHI according to the level of pollution particle matters and volatile organic compounds (VOCs)
measure: The impact of pollution and pollens on sleep quality in patients with AR.
time frame: 6 days
description: Change in Pittsburgh score according to the level of pollution particle matters and volatile organic compounds (VOCs)
measure: The impact of pollution on life quality
time frame: 6 days
description: Change in EQ-5D score according to the level of pollution particle matters and volatile organic compounds (VOCs)
measure: To analyze variations in medications and impact on sleep during the pollen season and outside the pollen season.
time frame: 6 days
description: Change in number of medications (antiallergics and hypnotics) according to the level of pollution particle matters and volatile organic compounds (VOCs)
arm group label: patients AR (+) and sleep apnea (+)
arm group type: Active Comparator
description: Patients with AR and obstructive sleep apnea (OSA) will have sleep and pollution exposure recordings
arm group label: AR (-) and sleep apnea (+)
arm group type: Active Comparator
description: Patients without allergic rhinitis (+ sleep apnea) will have sleep and pollution exposure recordings
arm group label: AR (+) and sleep apnea (-)
arm group type: Active Comparator
description: Patients with allergic rhinitis but no sleep apnea will have sleep and pollution exposure recordings
arm group label: AR (-) and sleep apnea (-)
arm group type: Sham Comparator
description: Volunteers without allergic rhinitis and no sleep apnea will have sleep and pollution exposure recordings
intervention type: Other
intervention name: Pollution exposure
description: Pollution exposure and sleep data will be recorded by pollution sensor and polysomnography respectively. In order to compare the variations according to the pollinisation season and the allergic rhinitis status of the patients.
arm group label: AR (+) and sleep apnea (-)
arm group label: AR (-) and sleep apnea (+)
arm group label: AR (-) and sleep apnea (-)
arm group label: patients AR (+) and sleep apnea (+)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Louis PEPIN
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
responsible party type: Sponsor
mesh term: Rhinitis
mesh term: Rhinitis, Allergic
mesh term: Respiration Disorders
mesh term: Respiratory Tract Diseases
sharing ipd: Undecided