<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/NCT02970695</url>
  </required_header>
  <id_info>
    <org_study_id>13144061</org_study_id>
    <nct_id>NCT02970695</nct_id>
  </id_info>
  <brief_title>Auriculotherapy on Older People With Insomnia</brief_title>
  <official_title>Effectiveness of Auriculotherapy on Older People With Insomnia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective To determine the optimum treatment protocol of auriculotherapy (AT) on the&#xD;
      improvement of sleep conditions and quality of life on the elders with insomnia.&#xD;
&#xD;
      Research hypothesis The use of combined LAT plus MAT is more effective than MAT/LAT alone on&#xD;
      the improvement of sleep conditions and quality of life in the elderly with insomnia.&#xD;
&#xD;
      Design and subjects This is a 3-arm double-blinded randomised trial. Subjects aged ≥65 and&#xD;
      exhibit poor sleep conditions are recruited.&#xD;
&#xD;
      Interventions Group 1: Subjects will receive a deactivated laser treatment followed by MAT.&#xD;
      Group 2: Subjects will receive LAT and placebo MAT. Group 3: Subjects will receive a combined&#xD;
      approach (LAT plus MAT).&#xD;
&#xD;
      The treatment will be delivered 3 times/week, with a 6-week treatment period, on seven&#xD;
      specific auricular points.&#xD;
&#xD;
      Main outcome measures Sleep conditions and quality of life will be evaluated at baseline; end&#xD;
      of 6-week treatment; and at 6-week, 12-week, and 6-month follow-up periods.&#xD;
&#xD;
      Data analysis Descriptive statistics, chi-square analysis, ANOVA, paired t-test, and mixed&#xD;
      effect modeling will be conducted as appropriate.&#xD;
&#xD;
      Expected results This study would advance our knowledge the optimum treatment protocol of AT&#xD;
      in the improvement of the sleep conditions of the elderly population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Actual">May 2, 2018</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>up to 6-month follow up</time_frame>
    <description>for collecting data related to the sleep patterns of the subjects. The total score ranges from 0 to 21, with a score greater than five indicating poor sleep quality. Chong and Cheung19 have validated the Cantonese-PSQI and have reported a high internal consistency of 0.75.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep latency</measure>
    <time_frame>up to 6-month follow up</time_frame>
    <description>Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Sleep latency refers to the length of time it takes from lying down for the night until sleep onset.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wake after sleep onset</measure>
    <time_frame>up to 6-month follow up</time_frame>
    <description>Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Wake after sleep onset refers to the amount of time test subjects have spent awake after initially falling asleep and before they awaken for good.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total sleep time</measure>
    <time_frame>up to 6-month follow up</time_frame>
    <description>Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Total sleep time refers to the actual sleep time in a sleep episode.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep efficiency</measure>
    <time_frame>up to 6-month follow up</time_frame>
    <description>Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Sleep efficiency is the ratio of total time spent asleep (total sleep time) in an evening to the total amount of time spent in bed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Chinese (HK) specific SF-12 v2©</measure>
    <time_frame>up to 6-month follow up</time_frame>
    <description>to evaluate the quality of life of the subjects, and has been found to have positive psychometric properties for use in the local population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire</measure>
    <time_frame>up to 6-month follow up</time_frame>
    <description>to evaluate the depression status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index</measure>
    <time_frame>up to 6-month follow up</time_frame>
    <description>to evaluate sleep conditions</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The 'Subjects' expectation questionnaire'</measure>
    <time_frame>up to post-intervention at 6 weeks</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">147</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>Treatment arm 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>To achieve a blinding and placebo effect of the subject, the laser device will be switched to &quot;power off&quot; mode (i.e. deactivated laser) for acupoint &quot;stimulation&quot; before the application of MAT. The subjects will be asked to wear a pair of laser protective goggles so as to &quot;blind&quot; them during treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment arm 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will receive LAT. A laser device (Pointer Pulse™) will be used in this study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment arm 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive a combined approach that includes the use of LAT plus MAT. LAT will be administered prior to MAT application on the selected auricular points, and the procedures used will be similar to the procedures described for Group 1 and Group 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>magneto-auriculotherapy (MAT)</intervention_name>
    <description>Subjects will then receive MAT. The magnetic pellets will have ~200 gauss/pellet magnetic flux densities on average, with a diameter of 1.76 mm.The experimental object will be applied to the seven selected acupoints as detected by an acupoint detector. Only one ear will receive treatment at a time, and the pellets will remain in situ for two days before the next change.</description>
    <arm_group_label>Treatment arm 1</arm_group_label>
    <arm_group_label>Treatment arm 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser auriculotherapy (LAT)</intervention_name>
    <description>A laser device (Pointer Pulse™)15 will be used in this study. This device has a wavelength of 650 nm, an average output power of 2.5 mW, an energy density of 1 minute with 0.54 J/cm,2 and a pulse of 10 Hz, which is a common acceptable dosage for clinical use. 16, 17 This application is a low-energy laser therapy (LLLT), in which the energy level emitted from the device is approximately comparable to a teaching pointer. A 1-minute treatment using the continuous mode of the device will be directly applied to the selected acupoints. Laser protective goggles will be provided to the subjects and the researcher for eyes protection</description>
    <arm_group_label>Treatment arm 2</arm_group_label>
    <arm_group_label>Treatment arm 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteers who are aged 65 or above&#xD;
&#xD;
          -  Report having difficulty falling or staying asleep, and/or frequent nocturnal&#xD;
             awakenings&#xD;
&#xD;
          -  At least three nights per week, sleep disturbance has lasted for a minimum of six&#xD;
             months&#xD;
&#xD;
          -  Their sleep is of poor quality as indicated by a PSQI score greater than five.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  profound physical illness, such as stroke&#xD;
&#xD;
          -  diagnosed with obstructive sleep apnoea&#xD;
&#xD;
          -  having a hearing aid or pacemaker in situ (to prevent the magnetic pellets from&#xD;
             interfering with the devices)&#xD;
&#xD;
          -  receiving AT within the preceding 6 months,&#xD;
&#xD;
          -  suffering from aural injuries or infections, and&#xD;
&#xD;
          -  inability to understand instructions or give consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lorna Suen, BN, MPH, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Nursing, The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Neighbourhood Advice-Action Council</name>
      <address>
        <city>Hong Kong</city>
        <zip>00000</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>May 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>October 17, 2018</last_update_submitted>
  <last_update_submitted_qc>October 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Lorna Suen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>insomnia</keyword>
  <keyword>older people</keyword>
  <keyword>auriculotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02970695
org study id: 13144061
nct id: NCT02970695
lead sponsor: 
has dmc: No
Objective To determine the optimum treatment protocol of auriculotherapy (AT) on the
      improvement of sleep conditions and quality of life on the elders with insomnia.

      Research hypothesis The use of combined LAT plus MAT is more effective than MAT/LAT alone on
      the improvement of sleep conditions and quality of life in the elderly with insomnia.

      Design and subjects This is a 3-arm double-blinded randomised trial. Subjects aged ≥65 and
      exhibit poor sleep conditions are recruited.

      Interventions Group 1: Subjects will receive a deactivated laser treatment followed by MAT.
      Group 2: Subjects will receive LAT and placebo MAT. Group 3: Subjects will receive a combined
      approach (LAT plus MAT).

      The treatment will be delivered 3 times/week, with a 6-week treatment period, on seven
      specific auricular points.

      Main outcome measures Sleep conditions and quality of life will be evaluated at baseline; end
      of 6-week treatment; and at 6-week, 12-week, and 6-month follow-up periods.

      Data analysis Descriptive statistics, chi-square analysis, ANOVA, paired t-test, and mixed
      effect modeling will be conducted as appropriate.

      Expected results This study would advance our knowledge the optimum treatment protocol of AT
      in the improvement of the sleep conditions of the elderly population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pittsburgh Sleep Quality Index (PSQI)
time frame: up to 6-month follow up
description: for collecting data related to the sleep patterns of the subjects. The total score ranges from 0 to 21, with a score greater than five indicating poor sleep quality. Chong and Cheung19 have validated the Cantonese-PSQI and have reported a high internal consistency of 0.75.
measure: Sleep latency
time frame: up to 6-month follow up
description: Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Sleep latency refers to the length of time it takes from lying down for the night until sleep onset.
measure: Wake after sleep onset
time frame: up to 6-month follow up
description: Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Wake after sleep onset refers to the amount of time test subjects have spent awake after initially falling asleep and before they awaken for good.
measure: Total sleep time
time frame: up to 6-month follow up
description: Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Total sleep time refers to the actual sleep time in a sleep episode.
measure: Sleep efficiency
time frame: up to 6-month follow up
description: Actiwatch 2 Device with 0.025G ultra-high sensitivity will be used for data collection. Sleep parameters, including sleep latency, waking after sleep onset, total sleep time, and sleep efficiency are identified. Participants have to wear the device for 7 consecutive days, 24 hours a day, for each timepoint measurements on the wrist of the non-dominant hand to determine the overall sleep conditions within a certain period. Removal (if any) of the actiwatch should be recorded in a logbook. Sleep efficiency is the ratio of total time spent asleep (total sleep time) in an evening to the total amount of time spent in bed.
measure: The Chinese (HK) specific SF-12 v2©
time frame: up to 6-month follow up
description: to evaluate the quality of life of the subjects, and has been found to have positive psychometric properties for use in the local population
measure: Patient Health Questionnaire
time frame: up to 6-month follow up
description: to evaluate the depression status
measure: Insomnia Severity Index
time frame: up to 6-month follow up
description: to evaluate sleep conditions
measure: The 'Subjects' expectation questionnaire'
time frame: up to post-intervention at 6 weeks
arm group label: Treatment arm 1
arm group type: Active Comparator
description: To achieve a blinding and placebo effect of the subject, the laser device will be switched to "power off" mode (i.e. deactivated laser) for acupoint "stimulation" before the application of MAT. The subjects will be asked to wear a pair of laser protective goggles so as to "blind" them during treatment.
arm group label: Treatment arm 2
arm group type: Active Comparator
description: Subjects will receive LAT. A laser device (Pointer Pulse™) will be used in this study.
arm group label: Treatment arm 3
arm group type: Experimental
description: Subjects will receive a combined approach that includes the use of LAT plus MAT. LAT will be administered prior to MAT application on the selected auricular points, and the procedures used will be similar to the procedures described for Group 1 and Group 2.
intervention type: Device
intervention name: magneto-auriculotherapy (MAT)
description: Subjects will then receive MAT. The magnetic pellets will have ~200 gauss/pellet magnetic flux densities on average, with a diameter of 1.76 mm.The experimental object will be applied to the seven selected acupoints as detected by an acupoint detector. Only one ear will receive treatment at a time, and the pellets will remain in situ for two days before the next change.
arm group label: Treatment arm 1
arm group label: Treatment arm 3
intervention type: Device
intervention name: Laser auriculotherapy (LAT)
description: A laser device (Pointer Pulse™)15 will be used in this study. This device has a wavelength of 650 nm, an average output power of 2.5 mW, an energy density of 1 minute with 0.54 J/cm,2 and a pulse of 10 Hz, which is a common acceptable dosage for clinical use. 16, 17 This application is a low-energy laser therapy (LLLT), in which the energy level emitted from the device is approximately comparable to a teaching pointer. A 1-minute treatment using the continuous mode of the device will be directly applied to the selected acupoints. Laser protective goggles will be provided to the subjects and the researcher for eyes protection
arm group label: Treatment arm 2
arm group label: Treatment arm 3
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lorna Suen, BN, MPH, PhD
role: Principal Investigator
affiliation: School of Nursing, The Hong Kong Polytechnic University
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Lorna Suen
investigator title: Associate Professor
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No