<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/NCT02260297</url>
  </required_header>
  <id_info>
    <org_study_id>CCEMD-023</org_study_id>
    <nct_id>NCT02260297</nct_id>
  </id_info>
  <brief_title>A Study of Wrist Actigraphy in Overweight and Obese Adults With Sleep Disorders</brief_title>
  <official_title>A Study of Wrist Actigraphy in Overweight and Obese Adults With Sleep Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      70 overweight or obese adults with sleep disorders will be recruited for this study, in which&#xD;
      the investigators aim to compare wrist actigraphy with polysomnography (PSG) for sleep&#xD;
      monitoring. It is to evaluate the applications of Jawbone Up2 with the sleep parameters&#xD;
      derived from this actigraphy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As an observation study, it will recruit 70 overweight or obese patients with sleep disorders&#xD;
      who meet the selection criteria: clinical records and AIS at a tertiary hospital. The&#xD;
      patients will sign the informed consent form. The involved patients and doctors will receive&#xD;
      related training.&#xD;
&#xD;
      These patients will receive the sleep monitoring from 21:00 to 6:00 in sleep monitoring&#xD;
      laboratory in Ruijin Hospital. They will receive the PSG and Jawbone Up 2 sleep monitoring at&#xD;
      the same time. Sleep parameters derived from actigraphy and PSG will be compared in multiple&#xD;
      night recordings such as total sleep time, wake after sleep onset, sleep onset latency,&#xD;
      awakening, sleep efficiency, total time in bed,. The aim is to assess the validation of&#xD;
      actigraphy in overweight or obese patients with sleep disorders.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Total Sleep Time, TST</measure>
    <time_frame>10 hrs</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Wake After Sleep Onset, WASO</measure>
    <time_frame>10 hrs</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep Onset Latency, SOL</measure>
    <time_frame>10 hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of arousal during sleep,awakenings</measure>
    <time_frame>10 hrs</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Efficiency, SE</measure>
    <time_frame>10 hrs</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">69</enrollment>
  <condition>Sleep Disorders</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wrist Actigraphy(motion sensors)with light sensors-Jawbone Up 2</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Overweight and obese adults with sleep disorders&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Have one or more sleep disorders such as consecutive snoring, insomnia, sleep apnea,&#xD;
             narcolepsy, delayed sleep phase syndrome&#xD;
&#xD;
          -  Athens Insomnia Scale (AIS)&gt;6&#xD;
&#xD;
          -  BMI&gt;25&#xD;
&#xD;
          -  Agree to participate in the study and have signed the inform consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Terminal illness&#xD;
&#xD;
          -  Physically-challenged and paralyzed patients&#xD;
&#xD;
          -  Intend to receive selective surgery, to get pregnancy and breast feeding in three&#xD;
             months&#xD;
&#xD;
          -  Long-term use of the sleeping pills&#xD;
&#xD;
          -  Hearing loss or severe visual disorder;&#xD;
&#xD;
          -  Mental disorders&#xD;
&#xD;
          -  Dementia or communication disorders&#xD;
&#xD;
          -  Unable to complete an all night sleep monitoring&#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>Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 5, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>December 2, 2014</last_update_submitted>
  <last_update_submitted_qc>December 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Guang Ning</investigator_full_name>
    <investigator_title>Shanghai Jiao Tong University School of Medicine</investigator_title>
  </responsible_party>
  <keyword>Actigraphy</keyword>
  <keyword>overweight and obese adults</keyword>
  <keyword>sleep disorders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Overweight</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/NCT02260297
org study id: CCEMD-023
nct id: NCT02260297
lead sponsor: 
collaborator: 
has dmc: No
70 overweight or obese adults with sleep disorders will be recruited for this study, in which
      the investigators aim to compare wrist actigraphy with polysomnography (PSG) for sleep
      monitoring. It is to evaluate the applications of Jawbone Up2 with the sleep parameters
      derived from this actigraphy.
As an observation study, it will recruit 70 overweight or obese patients with sleep disorders
      who meet the selection criteria: clinical records and AIS at a tertiary hospital. The
      patients will sign the informed consent form. The involved patients and doctors will receive
      related training.

      These patients will receive the sleep monitoring from 21:00 to 6:00 in sleep monitoring
      laboratory in Ruijin Hospital. They will receive the PSG and Jawbone Up 2 sleep monitoring at
      the same time. Sleep parameters derived from actigraphy and PSG will be compared in multiple
      night recordings such as total sleep time, wake after sleep onset, sleep onset latency,
      awakening, sleep efficiency, total time in bed,. The aim is to assess the validation of
      actigraphy in overweight or obese patients with sleep disorders.
observational model: Cohort
time perspective: Prospective
measure: Total Sleep Time, TST
time frame: 10 hrs
measure: Wake After Sleep Onset, WASO
time frame: 10 hrs
measure: Sleep Onset Latency, SOL
time frame: 10 hrs
measure: Frequency of arousal during sleep,awakenings
time frame: 10 hrs
measure: Sleep Efficiency, SE
time frame: 10 hrs
intervention type: Device
intervention name: Wrist Actigraphy(motion sensors)with light sensors-Jawbone Up 2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Guang Ning
investigator title: Shanghai Jiao Tong University School of Medicine
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Overweight