xml: <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/NCT05991141</url>
    </required_header>
    <id_info>
      <org_study_id>CSEULS-PI-029/2022</org_study_id>
      <nct_id>NCT05991141</nct_id>
    </id_info>
    <brief_title>Could Apnea Induce Hypoalgesia?</brief_title>
    <official_title>Could Apnea Induce Hypoalgesia? An Explorative Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centro Universitario La Salle</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centro Universitario La Salle</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>
        A randomized controlled trial (RCT) in healthy subjects will be conducted with the following&#xD;
        aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain&#xD;
        Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response&#xD;
        correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts,&#xD;
        Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A randomized controlled trial (RCT) in healthy subjects will be conducted with the following&#xD;
        aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain&#xD;
        Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response&#xD;
        correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts&#xD;
        Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Actual">May 15, 2023</completion_date>
    <primary_completion_date type="Actual">May 15, 2023</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pressure Pain Threshold</measure>
      <time_frame>Before and immediately after the interventions</time_frame>
      <description>PPT refers to the minimal amount of pressure needed to cause the first sensation of pain. The mechanical pressure algometer (PAIN TEST™ FPX 25, Wagner Instruments, Greenwich, CT, USA) counted with a round rubber disc of 1 cm2, displaying values in Kg, hence, data was expressed in Kg/cm2. Two locations, in upper and lower limbs, were examined to examine systemic hypoalgesia effects. The dorsal distal-phalange base of the thumb and tibialis anterior muscle belly, both in the dominant limb, were tested. These regions were marked with a pen before assessments, to repeat the trials in the same place. Three trials were tested in each location, with 30 seconds rest between trials. Pressure speed was paced with a metronome applying a constant force of 0.5 Kg/cm2/s ± 0.1 Kg/cm2/s.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Conditioned pain modulation</measure>
      <time_frame>Before and immediately after the interventions</time_frame>
      <description>Conditioning stimulus was applied on the contralateral limb to test stimulus, since its arrangement does not influence CPM response. Only controversial CPM response have appeared when tests and conditioned stimuli were applied on the same body region. Ischemic pain was applied as conditioning stimulus and PPT as test stimulus. Ischemic pain was provoked inflating a sphygmomanometer at the proximal region of the non-dominant arm. When inflated up to 180-200 mmHg patients were asked to actively move fingers and wrist. They were asketd to report when a 7/10 pain in Numerical Pain Rating Scale (NPRS) scale was reached. In that moment, three trials of test stimuli were applied on the dorsal distal-phalange base of the thumb in the dominant arm, while maintaining the ischemic pain perception.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart Rate and Oxygen Saturation</measure>
      <time_frame>During the intervention and for 2 minutes additionally after the end of the intervention</time_frame>
      <description>We video-taped HR and SpO2 values during the 6 min interventions and 2 minutes afterwards to explore their changes during and after interventions. HR and SpO2 data were extracted in each second. These values would be graphically displayed. Peak %HRmax and minimum SpO2, and means of both variables, value would be extracted from the 6-minute interventions. HR zones or exercise-induced hypoxemia zones were also recorded.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rated Perceived Exertion</measure>
      <time_frame>This outcome was assessed immediately after having finished the intervention protocols</time_frame>
      <description>Apnea and control interventions were explored in terms of Rated Perceived Exertion in with Borg's modified CR-10</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Pain</condition>
    <condition>Apnea</condition>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Experimental Group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Control Group</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Apnea</intervention_name>
      <description>In both experimental and control groups participants walked on a treadmill at 5.5 km/h with 5º inclination for 6 minutes. The experimental group (EG) added throughout the 6 minutes intervention the following breathing pattern cyclically: 5 seconds breathing normally followed by 10 seconds of low volume apnoea, performing a total of 24 cycles of normal breathing continued by apnoea.</description>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control Intervention</intervention_name>
      <description>In both experimental and control groups participants walked on a treadmill at 5.5 km/h with 5º inclination for 6 minutes. The Control group (CG) performed this protocol breathing normally.</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy participants&#xD;
  &#xD;
            -  18-30 years&#xD;
  &#xD;
            -  Currently pain-free&#xD;
  &#xD;
            -  Basal SpO2 ≥95%&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diabetes diagnosis&#xD;
  &#xD;
            -  Hypertension or hypotension diagnosis&#xD;
  &#xD;
            -  Pharmacological treatment&#xD;
  &#xD;
            -  Frequent pain during last month&#xD;
  &#xD;
            -  Drug consumption&#xD;
  &#xD;
            -  Self-harming behaviours&#xD;
  &#xD;
            -  Pregnant or potentially pregnant&#xD;
  &#xD;
            -  Cardiac or respiratory pathology&#xD;
  &#xD;
            -  Splenectomy or spleen disease&#xD;
  &#xD;
            -  Having performed moderate or high intensity physical activity 24 hours prior to the&#xD;
               study&#xD;
  &#xD;
            -  Not having slept the previous night&#xD;
  &#xD;
            -  Alcohol intake 24 hours prior to study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>José Fierro Marrero</last_name>
      <role>Principal Investigator</role>
      <affiliation>CSEULaSalle</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Centro Superior de Estudios La Salle</name>
        <address>
          <city>Madrid</city>
          <zip>28023</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Centro Universitario La Salle</investigator_affiliation>
      <investigator_full_name>José Fierro Marrero</investigator_full_name>
      <investigator_title>Predoctoral researcher</investigator_title>
    </responsible_party>
    <keyword>Pain</keyword>
    <keyword>Apnoea</keyword>
    <keyword>Apnea</keyword>
    <keyword>Hypoalgesia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Apnea</mesh_term>
    </condition_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Statistical Analysis Plan</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>February 27, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT05991141/SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05991141
  org study id: CSEULS-PI-029/2022
  nct id: NCT05991141
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A randomized controlled trial (RCT) in healthy subjects will be conducted with the following
        aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain
        Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response
        correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts,
        Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT.
  A randomized controlled trial (RCT) in healthy subjects will be conducted with the following
        aims: (1) Explore the effect of low pulmonary volume dynamic apnoea bouts on Pressure Pain
        Threshold (PPT) and conditioned pain modulation (CPM); (2) analyse whether CPM response
        correlates with apnoea induced hypoalgesia; (3) examine the association between apnoea bouts
        Rate of Perceived Exertion, hypoxemia and Heart Rate changes in PPT
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Pressure Pain Threshold
  time frame: Before and immediately after the interventions
  description: PPT refers to the minimal amount of pressure needed to cause the first sensation of pain. The mechanical pressure algometer (PAIN TEST™ FPX 25, Wagner Instruments, Greenwich, CT, USA) counted with a round rubber disc of 1 cm2, displaying values in Kg, hence, data was expressed in Kg/cm2. Two locations, in upper and lower limbs, were examined to examine systemic hypoalgesia effects. The dorsal distal-phalange base of the thumb and tibialis anterior muscle belly, both in the dominant limb, were tested. These regions were marked with a pen before assessments, to repeat the trials in the same place. Three trials were tested in each location, with 30 seconds rest between trials. Pressure speed was paced with a metronome applying a constant force of 0.5 Kg/cm2/s ± 0.1 Kg/cm2/s.
  measure: Conditioned pain modulation
  time frame: Before and immediately after the interventions
  description: Conditioning stimulus was applied on the contralateral limb to test stimulus, since its arrangement does not influence CPM response. Only controversial CPM response have appeared when tests and conditioned stimuli were applied on the same body region. Ischemic pain was applied as conditioning stimulus and PPT as test stimulus. Ischemic pain was provoked inflating a sphygmomanometer at the proximal region of the non-dominant arm. When inflated up to 180-200 mmHg patients were asked to actively move fingers and wrist. They were asketd to report when a 7/10 pain in Numerical Pain Rating Scale (NPRS) scale was reached. In that moment, three trials of test stimuli were applied on the dorsal distal-phalange base of the thumb in the dominant arm, while maintaining the ischemic pain perception.
  measure: Heart Rate and Oxygen Saturation
  time frame: During the intervention and for 2 minutes additionally after the end of the intervention
  description: We video-taped HR and SpO2 values during the 6 min interventions and 2 minutes afterwards to explore their changes during and after interventions. HR and SpO2 data were extracted in each second. These values would be graphically displayed. Peak %HRmax and minimum SpO2, and means of both variables, value would be extracted from the 6-minute interventions. HR zones or exercise-induced hypoxemia zones were also recorded.
  measure: Rated Perceived Exertion
  time frame: This outcome was assessed immediately after having finished the intervention protocols
  description: Apnea and control interventions were explored in terms of Rated Perceived Exertion in with Borg's modified CR-10
  arm group label: Experimental Group
  arm group type: Experimental
  description: Experimental Group
  arm group label: Control Group
  arm group type: Sham Comparator
  description: Control Group
  intervention type: Other
  intervention name: Apnea
  description: In both experimental and control groups participants walked on a treadmill at 5.5 km/h with 5º inclination for 6 minutes. The experimental group (EG) added throughout the 6 minutes intervention the following breathing pattern cyclically: 5 seconds breathing normally followed by 10 seconds of low volume apnoea, performing a total of 24 cycles of normal breathing continued by apnoea.
  arm group label: Experimental Group
  intervention type: Other
  intervention name: Control Intervention
  description: In both experimental and control groups participants walked on a treadmill at 5.5 km/h with 5º inclination for 6 minutes. The Control group (CG) performed this protocol breathing normally.
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: José Fierro Marrero
  role: Principal Investigator
  affiliation: CSEULaSalle
  facility: 
  country: Spain
  responsible party type: Principal Investigator
  investigator affiliation: Centro Universitario La Salle
  investigator full name: José Fierro Marrero
  investigator title: Predoctoral researcher
  mesh term: Apnea
  provided document: 