<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/NCT02987179</url>
  </required_header>
  <id_info>
    <org_study_id>RRI-16-002</org_study_id>
    <nct_id>NCT02987179</nct_id>
  </id_info>
  <brief_title>Identification of Desaturation Episodes by Means of Continuous Measurement of Oxygen Saturation During Hemodialysis</brief_title>
  <official_title>Identification of Desaturation Episodes by Means of Continuous Measurement of Oxygen Saturation During Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Renal Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Renal Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The clinical diagnosis of sleep apnea is difficult among ESRD patients since the&#xD;
      characteristic clinical features of sleep apnea may be absent and since sleep-related&#xD;
      symptoms, such as fatigue and sleepiness, may be attributed to kidney failure. However, the&#xD;
      evaluation of patients with possible sleep apnea is the same among ESRD patients as in the&#xD;
      general population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</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>Identifying Intradialytis desaturation episodes</measure>
    <time_frame>1 week</time_frame>
    <description>• To determine the sensitivity and specificity of the CLM for identifying intradialytic desaturation episodes, using the WatchPAT device as the reference method.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>ESRD</condition>
  <condition>Sleep Apnea</condition>
  <condition>Oxygen Deficiency</condition>
  <arm_group>
    <arm_group_label>ESRD Patients</arm_group_label>
    <description>The following inclusion criteria must be met for each subject.&#xD;
Age ≥18 years and able to give written informed consent to the study&#xD;
On chronic hemodialysis for ≥ 90 days at time of enrollment&#xD;
Ability to read&#xD;
Consent to have video recording taken during study visit</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>Collect anthropomorphic, WatchPAT, Crit-line Monitor measurements as well as sleep questionnaires and video records</description>
    <arm_group_label>ESRD Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Chronic hemodialysis patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years and able to give written informed consent to the study&#xD;
&#xD;
          -  On chronic hemodialysis for ≥ 90 days at time of enrollment&#xD;
&#xD;
          -  Ability to read&#xD;
&#xD;
          -  Consent to have video recording taken during study visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with cognitive impairment to consent&#xD;
&#xD;
          -  Sickle cell anemia&#xD;
&#xD;
          -  Prescription of nasal oxygen&#xD;
&#xD;
          -  Simultaneous participation in another clinical trial that may affect breathing&#xD;
             frequency/patterns, blood oxygenation, sleep/wake cycle or other parameters related to&#xD;
             the outcomes of interest to this study&#xD;
&#xD;
          -  Use of a breathing device, e.g. CPAP&#xD;
&#xD;
          -  Central venous catheter used as vascular access for hemodialysis&#xD;
&#xD;
          -  Artificial fingernails (may disturb the measurement of the WatchPAT)&#xD;
&#xD;
          -  Use of one of the following medications: alpha blockers, short acting nitrates (less&#xD;
             than 3 hours before the study).&#xD;
&#xD;
          -  Permanent pacemaker&#xD;
&#xD;
          -  Sustained non-sinus cardiac arrhythmias.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Renal Research Institute</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2016</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>Hypoxia</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/NCT02987179
org study id: RRI-16-002
nct id: NCT02987179
lead sponsor: 
has dmc: No
The clinical diagnosis of sleep apnea is difficult among ESRD patients since the
      characteristic clinical features of sleep apnea may be absent and since sleep-related
      symptoms, such as fatigue and sleepiness, may be attributed to kidney failure. However, the
      evaluation of patients with possible sleep apnea is the same among ESRD patients as in the
      general population.
observational model: Cohort
time perspective: Prospective
measure: Identifying Intradialytis desaturation episodes
time frame: 1 week
description: • To determine the sensitivity and specificity of the CLM for identifying intradialytic desaturation episodes, using the WatchPAT device as the reference method.
arm group label: ESRD Patients
description: The following inclusion criteria must be met for each subject.
Age ≥18 years and able to give written informed consent to the study
On chronic hemodialysis for ≥ 90 days at time of enrollment
Ability to read
Consent to have video recording taken during study visit
intervention type: Other
intervention name: Observational
description: Collect anthropomorphic, WatchPAT, Crit-line Monitor measurements as well as sleep questionnaires and video records
arm group label: ESRD Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypoxia