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/NCT05975853</url>
    </required_header>
    <id_info>
      <org_study_id>Asia0727</org_study_id>
      <nct_id>NCT05975853</nct_id>
    </id_info>
    <brief_title>Effects of Binaural Beat Music on Elderly Sleep</brief_title>
    <official_title>Examining the Effects of Binaural Beat Music on Sleep Quality, Heart Rate Variability, and Depression in Older People With Poor Sleep Quality in a Long-term Care Institution: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Cheng Kung University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Cheng Kung University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background:&#xD;
  &#xD;
        Older people in long-term care institutions often have poor sleep quality and depression,&#xD;
        which may negatively affect their health and welfare. Binaural beat music (BBM) has been&#xD;
        proposed as a possible intervention. However, its effects on older people with poor sleep&#xD;
        quality in long-term care institutions is still unclear.&#xD;
  &#xD;
        Objective:&#xD;
  &#xD;
        This study aimed to examine the effects of binaural beat music on sleep quality, heart rate&#xD;
        variability, and depression in older people with poor sleep quality in a long-term care&#xD;
        institution&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        A single-blind randomized controlled trial design was employed and 64 older participants with&#xD;
        poor sleep quality were recruited from a long-term care institution in Taiwan. Participants&#xD;
        were randomized into the BBM group or control (sham) group (32 per group) and received 14&#xD;
        days of intervention. During the intervention period, participants in the experimental group&#xD;
        listened to 20 minutes of Taiwanese Hokkien oldies embedded with BBM once in the morning and&#xD;
        afternoon thrice a week. Participants in the control group only listened to Taiwanese Hokkien&#xD;
        oldies. Questionnaires and heart rate variability analysis were used to assess participants'&#xD;
        sleep quality, heart rate variability, and depressive symptoms.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2022</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">March 30, 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>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
      <time_frame>On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 10 minutes.</time_frame>
      <description>There were 18 questions in the PSQI, and participants used a self-rated method to fill in their sleep quality in the last month on a 4-point Likert scale. The total score range was 0-21 points. The higher the score, the poorer the sleep quality. This scale has seven dimensions, including: (1) Subjective sleep quality; (2) Sleep latency; (3) Sleep duration; (4) Sleep efficiency; (5) Sleep disturbances; (6) Daytime dysfunction; and (7) Use of sleep medication. PSQI had good validity and reliability(Tsai et al., 2005).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>HRV analyzer</measure>
      <time_frame>On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 5 minutes</time_frame>
      <description>HRV was used to measure heart rate variability, including five markers: (1) Mean heart rate; (2) SDNN: Standard deviation of all RR intervals, represent the physiological health of autonomic nervous system; the higher the SDNN, the better the physiological health of the autonomic nervous system; (3) nLF: Normalized low frequency, reflects sympathetic nervous activity. The higher the value, the greater the activity; (4) nHF: Normalized high frequency, reflects parasympathetic nervous activity. The higher the value, the greater the activity; (5) LF/HF, a marker reflecting sympathetic and parasympathetic nervous activity.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Geriatric Depression Scale (GDS)</measure>
      <time_frame>On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 5 minutes</time_frame>
      <description>The GDS was a self-rated scale used to evaluate depression status in older people. This scale contained 30 questions and a binary scoring method (Yes/No). We used the 15-item version and the total score ranged from 0 to 15 points. Scores of 0-4, 5-8, 9-11, and 12-15 points indicated normal, mild, moderate, and severe depression, respectively. A higher total score indicated greater depression severity.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">64</enrollment>
    <condition>Sleep Quality</condition>
    <arm_group>
      <arm_group_label>Binaural beat music group (BBM group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>20 minutes of music thrice a week (Monday, Wednesday, and Friday) for two weeks (total of 12 times)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>20 minutes of music thrice a week (Monday, Wednesday, and Friday) for two weeks (total of 12 times)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Binaural beat music group (BBM group)</intervention_name>
      <description>The participant sat on a chair with eyes closed and wore over-ear stereo headphones to listen to 15 minutes of Taiwanese Hokkien oldies (familiar music, can be selected by participant) with BBM embedded.</description>
      <arm_group_label>Binaural beat music group (BBM group)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control group</intervention_name>
      <description>The participant sat on a chair with eyes closed and wore over-ear stereo headphones to listen to 15 minutes of Taiwanese Hokkien oldies (familiar music, can be selected by participant) without BBM embedded.</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Inclusion criteria were participants who: were aged 65 years and older, had a PSQI&#xD;
               score&gt; 7, were able to understand questionnaire contents and communicate in Mandarin&#xD;
               or Taiwanese Hokkien, stayed in institution for 1 month and more, and did not receive&#xD;
               antidepressant within 3 months prior to and during the intervention.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Exclusion criteria were those with hearing loss, history of bipolar disorder or&#xD;
               schizophrenia diagnosed by a physician, and had an acute physiological disease, such&#xD;
               as cold, fracture, or trauma.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>75 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Asia Univeraity</name>
        <address>
          <city>Taichung</city>
          <state>WuFeng</state>
          <zip>41354</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Asia University</investigator_affiliation>
      <investigator_full_name>Yang Shang-Yu</investigator_full_name>
      <investigator_title>Assistant professor</investigator_title>
    </responsible_party>
    <!-- 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/NCT05975853
  org study id: Asia0727
  nct id: NCT05975853
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Background:
  
        Older people in long-term care institutions often have poor sleep quality and depression,
        which may negatively affect their health and welfare. Binaural beat music (BBM) has been
        proposed as a possible intervention. However, its effects on older people with poor sleep
        quality in long-term care institutions is still unclear.
  
        Objective:
  
        This study aimed to examine the effects of binaural beat music on sleep quality, heart rate
        variability, and depression in older people with poor sleep quality in a long-term care
        institution
  
        Methods:
  
        A single-blind randomized controlled trial design was employed and 64 older participants with
        poor sleep quality were recruited from a long-term care institution in Taiwan. Participants
        were randomized into the BBM group or control (sham) group (32 per group) and received 14
        days of intervention. During the intervention period, participants in the experimental group
        listened to 20 minutes of Taiwanese Hokkien oldies embedded with BBM once in the morning and
        afternoon thrice a week. Participants in the control group only listened to Taiwanese Hokkien
        oldies. Questionnaires and heart rate variability analysis were used to assess participants'
        sleep quality, heart rate variability, and depressive symptoms.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: Pittsburgh Sleep Quality Index (PSQI)
  time frame: On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 10 minutes.
  description: There were 18 questions in the PSQI, and participants used a self-rated method to fill in their sleep quality in the last month on a 4-point Likert scale. The total score range was 0-21 points. The higher the score, the poorer the sleep quality. This scale has seven dimensions, including: (1) Subjective sleep quality; (2) Sleep latency; (3) Sleep duration; (4) Sleep efficiency; (5) Sleep disturbances; (6) Daytime dysfunction; and (7) Use of sleep medication. PSQI had good validity and reliability(Tsai et al., 2005).
  measure: HRV analyzer
  time frame: On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 5 minutes
  description: HRV was used to measure heart rate variability, including five markers: (1) Mean heart rate; (2) SDNN: Standard deviation of all RR intervals, represent the physiological health of autonomic nervous system; the higher the SDNN, the better the physiological health of the autonomic nervous system; (3) nLF: Normalized low frequency, reflects sympathetic nervous activity. The higher the value, the greater the activity; (4) nHF: Normalized high frequency, reflects parasympathetic nervous activity. The higher the value, the greater the activity; (5) LF/HF, a marker reflecting sympathetic and parasympathetic nervous activity.
  measure: Geriatric Depression Scale (GDS)
  time frame: On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 5 minutes
  description: The GDS was a self-rated scale used to evaluate depression status in older people. This scale contained 30 questions and a binary scoring method (Yes/No). We used the 15-item version and the total score ranged from 0 to 15 points. Scores of 0-4, 5-8, 9-11, and 12-15 points indicated normal, mild, moderate, and severe depression, respectively. A higher total score indicated greater depression severity.
  arm group label: Binaural beat music group (BBM group)
  arm group type: Experimental
  description: 20 minutes of music thrice a week (Monday, Wednesday, and Friday) for two weeks (total of 12 times)
  arm group label: Control group
  arm group type: Sham Comparator
  description: 20 minutes of music thrice a week (Monday, Wednesday, and Friday) for two weeks (total of 12 times)
  intervention type: Other
  intervention name: Binaural beat music group (BBM group)
  description: The participant sat on a chair with eyes closed and wore over-ear stereo headphones to listen to 15 minutes of Taiwanese Hokkien oldies (familiar music, can be selected by participant) with BBM embedded.
  arm group label: Binaural beat music group (BBM group)
  intervention type: Other
  intervention name: Control group
  description: The participant sat on a chair with eyes closed and wore over-ear stereo headphones to listen to 15 minutes of Taiwanese Hokkien oldies (familiar music, can be selected by participant) without BBM embedded.
  arm group label: Control group
  criteria: 
  gender: All
  minimum age: 75 Years
  maximum age: 90 Years
  healthy volunteers: No
  facility: 
  country: Taiwan
  responsible party type: Principal Investigator
  investigator affiliation: Asia University
  investigator full name: Yang Shang-Yu
  investigator title: Assistant professor