<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/NCT04448470</url>
  </required_header>
  <id_info>
    <org_study_id>19-002</org_study_id>
    <nct_id>NCT04448470</nct_id>
  </id_info>
  <brief_title>Daytime Sleepiness in Patients With the Assessment of a Sleep-related Respiratory Disorder</brief_title>
  <official_title>Comparison Between the Situational and the Time-of-day Recording of Daytime Sleepiness in Patients With the Assessment of a Sleep-related Respiratory Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heinrich-Heine University, Duesseldorf</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heinrich-Heine University, Duesseldorf</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is not yet known whether an analysis of daytime sleepiness over the course of the day can&#xD;
      predict the diagnosis or severity of sleep apnea. The goal of the study is to examine whether&#xD;
      a psychometric determination of daytime sleepiness can adequately and practicably record&#xD;
      daytime sleepiness in patients with mainly sleep apnea in comparison to other standardized&#xD;
      methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Detailed Description: Sleep-related respiratory disorders are a common disease in the general&#xD;
      population. Untreated sleep apnea is associated with an increased risk of accidents, an&#xD;
      increased risk of perioperative complications and various cardiovascular diseases such as&#xD;
      arterial hypertension, coronary heart disease or stroke. Sleep apnea is often undetected. As&#xD;
      part of the diagnosis of sleep apnea, screening is usually carried out to assess the&#xD;
      probability of pre-testing before a sleep medical examination by means of anamnesis,&#xD;
      examination and recording of risk factors and comorbidities. Questionnaires play a decisive&#xD;
      role here. The Epworth Sleepiness Scale (ESS) or the STOP BANG questionnaires are often used&#xD;
      for this purpose. ESS asks about the probability of falling asleep in different situations.&#xD;
      With STOP BANG, the points daytime tiredness, snoring, breathing stops and various risk&#xD;
      factors such as age, sex, neck circumference, high blood pressure and overweight are asked.&#xD;
      The quality of the questionnaire used to assess the risk of sleep apnea is of crucial&#xD;
      importance, as it is usually the basis for the decision whether or not to perform further&#xD;
      sleep medical diagnostics. To date, there is no established, easy-to-use method for measuring&#xD;
      daytime sleepiness during the day. However, it can be assumed that the degree of daytime&#xD;
      sleepiness can predict the presence of sleep apnea. In a proof-of-concept study, the&#xD;
      psychometric determination of daytime sleepiness in a time series on one day in patients with&#xD;
      mainly sleep apnea will be measured.&#xD;
&#xD;
      The following questions should be answered:&#xD;
&#xD;
        1. Does daytime sleepiness in patients with sleep apnea measured by a scale-based,&#xD;
           psychometric time-series test show one or more characteristic patterns over the day?&#xD;
&#xD;
        2. Is there a relation between the degree of the scale based psychometric time series test&#xD;
           for daytime sleepiness and the severity of sleep apnea?&#xD;
&#xD;
        3. Is the test quality of the scale based psychometric time series test for predicting&#xD;
           sleep apnea better than the established Epworth Sleepiness Scale or STOP BANG&#xD;
           questionnaires.&#xD;
&#xD;
      The quantification of daytime sleepiness can potentially be of crucial importance both for&#xD;
      diagnostic procedures and for the assessment of the use of therapeutic measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 24, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</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>Prediction of Sleep Apnea</measure>
    <time_frame>at Baseline</time_frame>
    <description>the degree of daytime sleepiness can predict the presence of sleep apnea the degree of daytime sleepiness can predict the presence of sleep apnea</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Sleep-related Respiratory Disorder</condition>
  <arm_group>
    <arm_group_label>patients with a clinical suspicion of sleep apnea (n=150)</arm_group_label>
    <description>patients with a clinical suspicion of sleep apnea</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy subjects (n=10)</arm_group_label>
    <description>healthy subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire for recording daytime sleepiness over the course of the day</intervention_name>
    <description>Questionnaire for recording daytime sleepiness over the course of the day</description>
    <arm_group_label>healthy subjects (n=10)</arm_group_label>
    <arm_group_label>patients with a clinical suspicion of sleep apnea (n=150)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Anamnesis and physicial examination</intervention_name>
    <description>Anamnesis and physical examination, e.g. medication, comorbidities, complaints</description>
    <arm_group_label>healthy subjects (n=10)</arm_group_label>
    <arm_group_label>patients with a clinical suspicion of sleep apnea (n=150)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire for quantifying daytime sleepiness</intervention_name>
    <description>the Epworth Sleepiness Scale (ESS) questionnaire and the STOP BANG Questionnaire</description>
    <arm_group_label>healthy subjects (n=10)</arm_group_label>
    <arm_group_label>patients with a clinical suspicion of sleep apnea (n=150)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pulmonary function test</intervention_name>
    <description>The measured values of spirometry/body plethysmography, CO diffusion and blood gas analysis are documented, if available.</description>
    <arm_group_label>healthy subjects (n=10)</arm_group_label>
    <arm_group_label>patients with a clinical suspicion of sleep apnea (n=150)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Polygraphy</intervention_name>
    <description>Polygraphy is a non-invasive portable examination method that the patient uses in the home environment at night to measure possible sleep-related breathing disorders. Typically, the following measurement signals are recorded: nasal airflow, thoracic and abdominal breathing excursions, snoring and breathing sounds via a microphone, pulse, oxygen saturation and position. The evaluation results and the findings are checked by a physician. Essential parameters include the apnoea-hypopnoea index, the number of obstructive, central and mixed apnoea/hypopnoea, the number and duration of desaturation, snoring or the association with a certain position.</description>
    <arm_group_label>healthy subjects (n=10)</arm_group_label>
    <arm_group_label>patients with a clinical suspicion of sleep apnea (n=150)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with the clinical suspicion of sleep apnea and healthy subject&#xD;
&#xD;
        The healthy subjects will be recruited at the Lung and Allergy Centre, Practice for&#xD;
        Internal Medicine, Pneumology, Allergology, Sleep and Sports Medicine Neuss in the clinical&#xD;
        routine. The patients are from the Lung and Allergy Centre, Practice for Internal Medicine,&#xD;
        Pneumology, Allergology, Sleep and Sports Medicine in Neuss and from the Div. of&#xD;
        Cardiology, Pulmonary Disease and Vascular Medicine from the University Hospital&#xD;
        Düsseldorf.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria for patients&#xD;
&#xD;
          -  Age 18-80 years&#xD;
&#xD;
          -  Written informed consent to participate in this study&#xD;
&#xD;
          -  Patients with a clinical suspicion of sleep apnea&#xD;
&#xD;
        Exclusion criteria for patients:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Lack of consent to participate in the study&#xD;
&#xD;
          -  Lack of willingness and ability to participate in the study&#xD;
&#xD;
          -  Pregnancy and breast feeding period&#xD;
&#xD;
        Inclusion criteria for healthy subjects:&#xD;
&#xD;
          -  Age 18-45 years&#xD;
&#xD;
          -  no internal or psychiatric illness requiring therapy&#xD;
&#xD;
          -  not long-term drug therapy&#xD;
&#xD;
          -  no known sleep apnea.&#xD;
&#xD;
          -  Written consent to participate in this study&#xD;
&#xD;
        Exclusion criteria for healthy subjects:&#xD;
&#xD;
          -  Patients with sleep apnea&#xD;
&#xD;
          -  Age &lt;18 years or ≥ 45 years&#xD;
&#xD;
          -  Lack of consent to participate in the study&#xD;
&#xD;
          -  Pregnancy and breast feeding period&#xD;
&#xD;
          -  Lack of willingness and ability to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Malte Kelm, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Düsseldorf</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stefanie Keymel, MD</last_name>
    <phone>+492118118800</phone>
    <email>ctsu@med.uni-duesseldorf.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rabea Wagstaff, M.A.</last_name>
    <phone>+492118118914</phone>
    <email>ctsu@med.uni-duesseldorf.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Heinrich-Heine-University</name>
      <address>
        <city>Düsseldorf</city>
        <state>North Rhine-Westphalia</state>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefanie Keymel, MD</last_name>
      <phone>+492118118800</phone>
      <email>ctsu@med.uni-duesseldorf.de</email>
    </contact>
    <contact_backup>
      <last_name>Rabea Wagstaff, M.A.</last_name>
      <email>ctsu@med.uni-duesseldorf.de</email>
    </contact_backup>
    <investigator>
      <last_name>Stefanie Keymel, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stefan Krüger, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Malte Kelm, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lung and Allergy Centre</name>
      <address>
        <city>Neuss</city>
        <state>North Rhine-Westphalia</state>
        <zip>41462</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Johannes Uerscheln, MD</last_name>
    </contact>
    <investigator>
      <last_name>Johannes Uerscheln, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Heinrich-Heine University, Duesseldorf</investigator_affiliation>
    <investigator_full_name>Klinik für Kardiologie, Pneumologie und Angiologie</investigator_full_name>
    <investigator_title>Principle Investigator Dr. Stefanie Keymel</investigator_title>
  </responsible_party>
  <keyword>daytime sleepiness</keyword>
  <keyword>respiratory disorder</keyword>
  <keyword>sleep apnea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiration Disorders</mesh_term>
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Disorders of Excessive Somnolence</mesh_term>
    <mesh_term>Sleepiness</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/NCT04448470
org study id: 19-002
nct id: NCT04448470
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
It is not yet known whether an analysis of daytime sleepiness over the course of the day can
      predict the diagnosis or severity of sleep apnea. The goal of the study is to examine whether
      a psychometric determination of daytime sleepiness can adequately and practicably record
      daytime sleepiness in patients with mainly sleep apnea in comparison to other standardized
      methods.
Detailed Description: Sleep-related respiratory disorders are a common disease in the general
      population. Untreated sleep apnea is associated with an increased risk of accidents, an
      increased risk of perioperative complications and various cardiovascular diseases such as
      arterial hypertension, coronary heart disease or stroke. Sleep apnea is often undetected. As
      part of the diagnosis of sleep apnea, screening is usually carried out to assess the
      probability of pre-testing before a sleep medical examination by means of anamnesis,
      examination and recording of risk factors and comorbidities. Questionnaires play a decisive
      role here. The Epworth Sleepiness Scale (ESS) or the STOP BANG questionnaires are often used
      for this purpose. ESS asks about the probability of falling asleep in different situations.
      With STOP BANG, the points daytime tiredness, snoring, breathing stops and various risk
      factors such as age, sex, neck circumference, high blood pressure and overweight are asked.
      The quality of the questionnaire used to assess the risk of sleep apnea is of crucial
      importance, as it is usually the basis for the decision whether or not to perform further
      sleep medical diagnostics. To date, there is no established, easy-to-use method for measuring
      daytime sleepiness during the day. However, it can be assumed that the degree of daytime
      sleepiness can predict the presence of sleep apnea. In a proof-of-concept study, the
      psychometric determination of daytime sleepiness in a time series on one day in patients with
      mainly sleep apnea will be measured.

      The following questions should be answered:

        1. Does daytime sleepiness in patients with sleep apnea measured by a scale-based,
           psychometric time-series test show one or more characteristic patterns over the day?

        2. Is there a relation between the degree of the scale based psychometric time series test
           for daytime sleepiness and the severity of sleep apnea?

        3. Is the test quality of the scale based psychometric time series test for predicting
           sleep apnea better than the established Epworth Sleepiness Scale or STOP BANG
           questionnaires.

      The quantification of daytime sleepiness can potentially be of crucial importance both for
      diagnostic procedures and for the assessment of the use of therapeutic measures.
observational model: Cohort
time perspective: Prospective
measure: Prediction of Sleep Apnea
time frame: at Baseline
description: the degree of daytime sleepiness can predict the presence of sleep apnea the degree of daytime sleepiness can predict the presence of sleep apnea
arm group label: patients with a clinical suspicion of sleep apnea (n=150)
description: patients with a clinical suspicion of sleep apnea
arm group label: healthy subjects (n=10)
description: healthy subjects
intervention type: Other
intervention name: Questionnaire for recording daytime sleepiness over the course of the day
description: Questionnaire for recording daytime sleepiness over the course of the day
arm group label: healthy subjects (n=10)
arm group label: patients with a clinical suspicion of sleep apnea (n=150)
intervention type: Other
intervention name: Anamnesis and physicial examination
description: Anamnesis and physical examination, e.g. medication, comorbidities, complaints
arm group label: healthy subjects (n=10)
arm group label: patients with a clinical suspicion of sleep apnea (n=150)
intervention type: Other
intervention name: Questionnaire for quantifying daytime sleepiness
description: the Epworth Sleepiness Scale (ESS) questionnaire and the STOP BANG Questionnaire
arm group label: healthy subjects (n=10)
arm group label: patients with a clinical suspicion of sleep apnea (n=150)
intervention type: Diagnostic Test
intervention name: Pulmonary function test
description: The measured values of spirometry/body plethysmography, CO diffusion and blood gas analysis are documented, if available.
arm group label: healthy subjects (n=10)
arm group label: patients with a clinical suspicion of sleep apnea (n=150)
intervention type: Diagnostic Test
intervention name: Polygraphy
description: Polygraphy is a non-invasive portable examination method that the patient uses in the home environment at night to measure possible sleep-related breathing disorders. Typically, the following measurement signals are recorded: nasal airflow, thoracic and abdominal breathing excursions, snoring and breathing sounds via a microphone, pulse, oxygen saturation and position. The evaluation results and the findings are checked by a physician. Essential parameters include the apnoea-hypopnoea index, the number of obstructive, central and mixed apnoea/hypopnoea, the number and duration of desaturation, snoring or the association with a certain position.
arm group label: healthy subjects (n=10)
arm group label: patients with a clinical suspicion of sleep apnea (n=150)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Malte Kelm, Prof. Dr.
role: Study Chair
affiliation: University Hospital Düsseldorf
last name: Stefanie Keymel, MD
phone: +492118118800
email: ctsu@med.uni-duesseldorf.de
last name: Rabea Wagstaff, M.A.
phone: +492118118914
email: ctsu@med.uni-duesseldorf.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Heinrich-Heine University, Duesseldorf
investigator full name: Klinik für Kardiologie, Pneumologie und Angiologie
investigator title: Principle Investigator Dr. Stefanie Keymel
mesh term: Respiration Disorders
mesh term: Respiratory Tract Diseases
mesh term: Disorders of Excessive Somnolence
mesh term: Sleepiness
sharing ipd: Undecided