<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/NCT03773601</url>
  </required_header>
  <id_info>
    <org_study_id>Sleep Profiler and athletes</org_study_id>
    <nct_id>NCT03773601</nct_id>
  </id_info>
  <brief_title>Objective Sleep Behavior in Relation to a Nigth Competition in Athletes.</brief_title>
  <acronym>Sleep Profiler</acronym>
  <official_title>Objective Sleep Behavior in Relation to a Nigth Competition in Athletes: a Pilot Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Ortopedico Galeazzi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Ortopedico Galeazzi</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Sleep is a crucial factor for athletes' health and recovery. Many variables are able to&#xD;
      negatively influence the sleep of top-level athletes, such as: anxiety, long travels, high&#xD;
      volume or high-intensity training period, and a nigth competition too. Therefore, the aim of&#xD;
      this pilot study is to evalute how sleep quality changes in relation to a late nigth&#xD;
      competition in athletes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2018</start_date>
  <completion_date type="Actual">November 11, 2020</completion_date>
  <primary_completion_date type="Actual">November 11, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep Efficiency</measure>
    <time_frame>From the 1st to the 4th nigth of monitoring</time_frame>
    <description>Evaluation of the changes in Sleep Efficiency, evaluated by the Sleep Profiler, before (1st and 2nd nigths) and after (3rd and 4th nigths) a nigth competition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TQR</measure>
    <time_frame>From the 1st to the 4th nigth of monitoring</time_frame>
    <description>Evaluation of the changes in the subjective perception of recovery, evaluated with the Total Quality of Recovery Scale (TQR), before (1st and 2nd nigths) and after (3rd and 4th nigths) a nigth competition.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Sleep</condition>
  <condition>Athlete</condition>
  <condition>Sleep Deprivation</condition>
  <arm_group>
    <arm_group_label>Athletes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Athletes will undergo a 4-days sleep monitoring with the use of the Sleep Profler. At the same time, they will fill the Total Quality of Recovery (TQR) scale and the Pittsburgh Sleep Quality Index (PSQI).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sleep Profiler</intervention_name>
    <description>A 4-days sleep monitoring with the use of the Sleep Profiler. Data on objective sleep behavior will be collected.</description>
    <arm_group_label>Athletes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PSQI</intervention_name>
    <description>Fill the Pittsburgh Sleep Quality Index (PSQI) for the subjective evaluation of sleep.</description>
    <arm_group_label>Athletes</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TQR</intervention_name>
    <description>Fill the Total Quality of Recovery Scale (TQR), every morning for 4 consecutive days, to collect data on subjective perception of recovery,</description>
    <arm_group_label>Athletes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  both genders&#xD;
&#xD;
          -  age between 18 and 45&#xD;
&#xD;
          -  sport activity for &gt; or = to 8 hours/week.&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  part-time or shift worker.&#xD;
&#xD;
          -  Use of medications able to influence sleep&#xD;
&#xD;
          -  any medical conditions (injury) contraindicating physical exercise as diagnosed by a&#xD;
             sports medicine physician&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jacopo Antonino Vitale</name>
      <address>
        <city>Milano</city>
        <zip>20161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>November 12, 2020</last_update_submitted>
  <last_update_submitted_qc>November 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sleep</keyword>
  <keyword>Athlete</keyword>
  <keyword>Sleep Profiler</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Deprivation</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/NCT03773601
org study id: Sleep Profiler and athletes
nct id: NCT03773601
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Sleep is a crucial factor for athletes' health and recovery. Many variables are able to
      negatively influence the sleep of top-level athletes, such as: anxiety, long travels, high
      volume or high-intensity training period, and a nigth competition too. Therefore, the aim of
      this pilot study is to evalute how sleep quality changes in relation to a late nigth
      competition in athletes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sleep Efficiency
time frame: From the 1st to the 4th nigth of monitoring
description: Evaluation of the changes in Sleep Efficiency, evaluated by the Sleep Profiler, before (1st and 2nd nigths) and after (3rd and 4th nigths) a nigth competition.
measure: TQR
time frame: From the 1st to the 4th nigth of monitoring
description: Evaluation of the changes in the subjective perception of recovery, evaluated with the Total Quality of Recovery Scale (TQR), before (1st and 2nd nigths) and after (3rd and 4th nigths) a nigth competition.
arm group label: Athletes
arm group type: Experimental
description: Athletes will undergo a 4-days sleep monitoring with the use of the Sleep Profler. At the same time, they will fill the Total Quality of Recovery (TQR) scale and the Pittsburgh Sleep Quality Index (PSQI).
intervention type: Other
intervention name: Sleep Profiler
description: A 4-days sleep monitoring with the use of the Sleep Profiler. Data on objective sleep behavior will be collected.
arm group label: Athletes
intervention type: Other
intervention name: PSQI
description: Fill the Pittsburgh Sleep Quality Index (PSQI) for the subjective evaluation of sleep.
arm group label: Athletes
intervention type: Other
intervention name: TQR
description: Fill the Total Quality of Recovery Scale (TQR), every morning for 4 consecutive days, to collect data on subjective perception of recovery,
arm group label: Athletes
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Sleep Deprivation
sharing ipd: Undecided