<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/NCT02983565</url>
  </required_header>
  <id_info>
    <org_study_id>15IC2590</org_study_id>
    <nct_id>NCT02983565</nct_id>
  </id_info>
  <brief_title>Intelligent Oxygen Therapy During Sleep</brief_title>
  <official_title>The Assessment of Intelligent Oxygen Therapy (iO2T) in Patients With Respiratory Failure on Long-term Oxygen Therapy During Sleep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Long-term oxygen therapy improves survival in patients with severe hypoxia. However, some&#xD;
      patients despite this oxygen, experience episodes of low oxygen levels (intermittent hypoxia)&#xD;
      especially during sleep which may be harmful. In order to overcome this, the investigators&#xD;
      have designed an auto-titrating oxygen system (called intelligent oxygen therapy) which&#xD;
      automatically adjusts oxygen flow rates to maintain oxygen levels in patients already on&#xD;
      oxygen. This study will investigate whether the intelligent oxygen therapy system can prevent&#xD;
      intermittent hypoxia during sleep in patients already on long-term oxygen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Long-term oxygen therapy (LTOT) improves survival in patients with chronic obstructive&#xD;
      pulmonary disease (COPD) and severe persistent hypoxia. LTOT is prescribed at a fixed-flow&#xD;
      rate with the aim of maintaining a partial pressure of oxygen greater than or equal to 8&#xD;
      kilopascals (kPa). However, a number of studies have demonstrated that patients on home LTOT&#xD;
      experience episodes of intermittent hypoxia during rest, activities and especially sleep.&#xD;
      Simply increasing the oxygen flow rate at night can relieve this hypoxia but at the expense&#xD;
      of hyperoxia with its detrimental effects of hypercapnia and respiratory acidosis. Therefore,&#xD;
      a more targeted approach is needed to oxygen delivery. The investigators have devised an&#xD;
      auto-titrating oxygen system (intelligent oxygen therapy [iO2Ts]) which delivers variable&#xD;
      flow oxygen to maintain a pre-set specific oxygen saturation ( SpO2) target. The system can&#xD;
      avoid the dual hazards of hypoxia and hyperoxia and potentially optimise LTOT.&#xD;
&#xD;
      This study will be investigating whether the iO2Ts can reduce intermittent hypoxia during&#xD;
      sleep compared to usual fixed flow oxygen in patients on LTOT. Nineteen patients will be&#xD;
      recruited to undergo two sleep studies each on two different nights; one on their usual LTOT&#xD;
      flow rate and one of the iO2Ts. During both sleep studies, all participants will have full&#xD;
      polysomnography, oxygen and transcutaneous carbon dioxide monitoring. The primary outcome&#xD;
      will the percentage of time spent with SpO2 &lt; 90% during sleep.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of time spent with SpO2 &lt;90% during sleep</measure>
    <time_frame>10 hours during sleep</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of time spent with SpO2 &gt;96% during sleep</measure>
    <time_frame>10 hours during sleep</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean transcutaneous carbon dioxide level during sleep</measure>
    <time_frame>10 hours during sleep</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The peak transcutaneous carbon dioxide level during sleep</measure>
    <time_frame>10 hours during sleep</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The mean sleep SpO2</measure>
    <time_frame>10 hours during sleep</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality as measured on a visual analogue scale (0 - 100mm).</measure>
    <time_frame>10 hours during sleep</time_frame>
    <description>The morning after the sleep study, participants will complete a visual analogue scale of their sleep quality. The visual analogue scale is on a A4 paper, it is a straight line of 100mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Sleep time</measure>
    <time_frame>10 hours during sleep</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep efficiency. This is the total amount of time the patients actually slept divided by the total time they were in bed.</measure>
    <time_frame>10 hours during sleep</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">19</enrollment>
  <condition>Respiration Failure</condition>
  <arm_group>
    <arm_group_label>Sleep study on usual long-term oxygen therapy flow rate</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will have a sleep study on their usual LTOT flow rate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sleep study on the intelligent oxygen therapy system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will have a sleep study on the intelligent oxygen therapy system. This system will supply variable flow oxygen to match a pre-set oxygen saturation target of 93% during sleep.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intelligent oxygen therapy system (iO2Ts)</intervention_name>
    <arm_group_label>Sleep study on the intelligent oxygen therapy system</arm_group_label>
    <other_name>Auto-titrating oxygen system</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  On or eligible for long-term oxygen therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Nocturnal use of non-invasive ventilation (NIV) or continuous positive airways&#xD;
             pressure (CPAP)&#xD;
&#xD;
          2. A diagnosis of obstructive sleep apnoea&#xD;
&#xD;
          3. A diagnosis of a neuromuscular disease&#xD;
&#xD;
          4. Daytime partial pressure of carbon dioxide &gt; 8.0 kPa&#xD;
&#xD;
          5. Inability to consent for the study&#xD;
&#xD;
          6. Exacerbation of the underlying lung disease or chest infection in the previous 4 weeks&#xD;
&#xD;
          7. Pregnancy&#xD;
&#xD;
          8. Severe co-morbidities&#xD;
&#xD;
          9. Patients with a tracheostomy&#xD;
&#xD;
         10. Long-term oxygen therapy flow rate ≥ 4 litre per minute&#xD;
&#xD;
         11. Inability to understand the English language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohammad E Moghal, MBBS</last_name>
    <phone>020 7352 8121</phone>
    <phone_ext>4183</phone_ext>
    <email>m.moghal@rbht.nhs.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Royal Brompton and Harefield NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammad E Moghal, MBBS</last_name>
      <phone>020 7352 8121</phone>
      <phone_ext>4183</phone_ext>
      <email>m.moghal@rbht.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 2, 2016</last_update_submitted>
  <last_update_submitted_qc>December 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Long-term oxygen therapy</keyword>
  <keyword>Intelligent oxygen therapy system</keyword>
  <keyword>Auto-titrating oxygen system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share IPD.</ipd_description>
  </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/NCT02983565
org study id: 15IC2590
nct id: NCT02983565
lead sponsor: 
has dmc: No
Long-term oxygen therapy improves survival in patients with severe hypoxia. However, some
      patients despite this oxygen, experience episodes of low oxygen levels (intermittent hypoxia)
      especially during sleep which may be harmful. In order to overcome this, the investigators
      have designed an auto-titrating oxygen system (called intelligent oxygen therapy) which
      automatically adjusts oxygen flow rates to maintain oxygen levels in patients already on
      oxygen. This study will investigate whether the intelligent oxygen therapy system can prevent
      intermittent hypoxia during sleep in patients already on long-term oxygen.
Long-term oxygen therapy (LTOT) improves survival in patients with chronic obstructive
      pulmonary disease (COPD) and severe persistent hypoxia. LTOT is prescribed at a fixed-flow
      rate with the aim of maintaining a partial pressure of oxygen greater than or equal to 8
      kilopascals (kPa). However, a number of studies have demonstrated that patients on home LTOT
      experience episodes of intermittent hypoxia during rest, activities and especially sleep.
      Simply increasing the oxygen flow rate at night can relieve this hypoxia but at the expense
      of hyperoxia with its detrimental effects of hypercapnia and respiratory acidosis. Therefore,
      a more targeted approach is needed to oxygen delivery. The investigators have devised an
      auto-titrating oxygen system (intelligent oxygen therapy [iO2Ts]) which delivers variable
      flow oxygen to maintain a pre-set specific oxygen saturation ( SpO2) target. The system can
      avoid the dual hazards of hypoxia and hyperoxia and potentially optimise LTOT.

      This study will be investigating whether the iO2Ts can reduce intermittent hypoxia during
      sleep compared to usual fixed flow oxygen in patients on LTOT. Nineteen patients will be
      recruited to undergo two sleep studies each on two different nights; one on their usual LTOT
      flow rate and one of the iO2Ts. During both sleep studies, all participants will have full
      polysomnography, oxygen and transcutaneous carbon dioxide monitoring. The primary outcome
      will the percentage of time spent with SpO2 < 90% during sleep.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The percentage of time spent with SpO2 <90% during sleep
time frame: 10 hours during sleep
measure: The percentage of time spent with SpO2 >96% during sleep
time frame: 10 hours during sleep
measure: The mean transcutaneous carbon dioxide level during sleep
time frame: 10 hours during sleep
measure: The peak transcutaneous carbon dioxide level during sleep
time frame: 10 hours during sleep
measure: The mean sleep SpO2
time frame: 10 hours during sleep
measure: Sleep quality as measured on a visual analogue scale (0 - 100mm).
time frame: 10 hours during sleep
description: The morning after the sleep study, participants will complete a visual analogue scale of their sleep quality. The visual analogue scale is on a A4 paper, it is a straight line of 100mm.
measure: Total Sleep time
time frame: 10 hours during sleep
measure: Sleep efficiency. This is the total amount of time the patients actually slept divided by the total time they were in bed.
time frame: 10 hours during sleep
arm group label: Sleep study on usual long-term oxygen therapy flow rate
arm group type: No Intervention
description: Participants will have a sleep study on their usual LTOT flow rate.
arm group label: Sleep study on the intelligent oxygen therapy system
arm group type: Experimental
description: Participants will have a sleep study on the intelligent oxygen therapy system. This system will supply variable flow oxygen to match a pre-set oxygen saturation target of 93% during sleep.
intervention type: Device
intervention name: Intelligent oxygen therapy system (iO2Ts)
arm group label: Sleep study on the intelligent oxygen therapy system
other name: Auto-titrating oxygen system
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mohammad E Moghal, MBBS
phone: 020 7352 8121
phone ext: 4183
email: m.moghal@rbht.nhs.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
sharing ipd: No
ipd description: No plan to share IPD.