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/NCT05963555</url>
    </required_header>
    <id_info>
      <org_study_id>2303738136</org_study_id>
      <nct_id>NCT05963555</nct_id>
    </id_info>
    <brief_title>PBM or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly</brief_title>
    <official_title>Evaluation of Photobiomodulation or Dry Float Therapy on Sleep Quality in Middle-aged and Elderly Individuals.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>West Virginia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>West Virginia University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main objective of this study is to assess the impact of implementing photobiomodulation&#xD;
        (PBM) therapy, either localized or whole body, or dry float on sleep quality in middle-aged&#xD;
        and elderly individuals experiencing sleep disturbance. As a secondary objective we will&#xD;
        analyze the effect of the treatments on other indices of recovery (subjective and objective)&#xD;
        via physiological monitoring in middle-aged and elderly individuals experiencing sleep&#xD;
        disturbance.&#xD;
  &#xD;
        The study will have 2 phases: Phase 1 will last 5 weeks and will serve as baseline data&#xD;
        collection of sleep quality. Phase 2 contains the experimental conditions and will last 13&#xD;
        weeks. Cognitive, behavioral, and physiological tests will be done at baseline (week 1) and&#xD;
        at the end of experimental period (week 18). Sleep tracking data will be collected daily.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In summary the study participants are expected to:&#xD;
  &#xD;
          -  Wear a study provided smart ring (OURA Ring) through the end of the study period (at&#xD;
             least 75% of the total study time) which measures sleep quantity/quality.&#xD;
  &#xD;
          -  Keep their smart phones nearby and charged while wearing their devices.&#xD;
  &#xD;
          -  Complete monthly surveys with questions about general well-being until the end of the&#xD;
             study period.&#xD;
  &#xD;
          -  Complete a testing battery consisting of cognitive tests, behavioral and mood&#xD;
             questionnaires, qEEG and physical assessments, in the beginning and at the end of the&#xD;
             study period.&#xD;
  &#xD;
          -  Complete the designated experimental condition 2- 3x/week for 12 weeks (at least 75% of&#xD;
             the total sessions), if applicable.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">July 2027</completion_date>
    <primary_completion_date type="Anticipated">July 2025</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in resting state electroencephalography (EEG)</measure>
      <time_frame>Changes from baseline versus end of study week 18</time_frame>
      <description>Electroencephalography (EEG) analysis looking for alterations in brain activity. A paired samples t-Test will be used to compare power activity at baseline and follow-up.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in the Patient Health Questionnaire (PHQ-9)</measure>
      <time_frame>Changes from baseline versus end of study week 18</time_frame>
      <description>Participants will complete the Patient Health Questionnaire (PHQ-9) once a month. The higher the score, the more severe the symptoms of depression. Scores range from 5-9 = mild, 10-14 = moderate, 15-19 = moderate severe, 20-27 severe depression</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in total sleep via Oura Ring</measure>
      <time_frame>Changes from baseline versus end of study week 18</time_frame>
      <description>Oura Ring will be used to track total sleep throughout the study. Increased total sleep values will indicate better quality sleep and decrease total sleep values will indicate poorer sleep.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in the Circadian Sleep Inventory</measure>
      <time_frame>Changes from baseline versus end of study week 18</time_frame>
      <description>Evaluate changes in the participants sleeping patterns. Higher values indicate poorer sleep quality.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Sleep Quality</condition>
    <arm_group>
      <arm_group_label>Whole-Body Photobiomodulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Light therapy in both the visible and near-infrared range (non-UV) applied to the whole body in a light pod or bed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dry Float</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Simulates the effects of traditional Float-REST therapy. Instead of contact with salt water, the dry float system has a very thin membrane that cradles the body and provides a warm sensation, similar to that experienced in a traditional flotation tank.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Localized Photobiomodulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Light therapy in both the visible and near-infrared range (non-UV) applied locally to only a specific body region.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants in the control group will be asked to keep their normal daily routine.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>NovoThor</intervention_name>
      <description>Following the baseline block (first four weeks), participants will use the NovoThor device 2-3 times per week for 20 minute sessions at the WVU Rockefeller Neuroscience Institute.</description>
      <arm_group_label>Whole-Body Photobiomodulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>VieLight</intervention_name>
      <description>Following the baseline block (first four weeks), participants will use the VieLight device 2-3 times per week for 20 minute sessions and may be completed at home.</description>
      <arm_group_label>Localized Photobiomodulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ZeroBody</intervention_name>
      <description>Following the baseline block (first four weeks), participants will use the Zerobody device 2-3 times per week for 20 minute sessions at the WVU Rockefeller Neuroscience Institute.</description>
      <arm_group_label>Dry Float</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female between 50-85 years of age&#xD;
  &#xD;
            -  Able and willing to give informed consent&#xD;
  &#xD;
            -  No significant untreated medical history&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have no mental or physical conditions that are deemed inappropriate for study&#xD;
               participation at investigator's discretion.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Camila Vieira Ligo Teixeira, PhD</last_name>
      <phone>304-293-6780</phone>
      <email>camila.vieiraligoteixeira@hsc.wvu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Carolyn Ferreyra</last_name>
      <phone>304-293-4944</phone>
      <email>carolyn.ferreyra@hsc.wvu.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>WVU Rockefeller Neuroscience Institute</name>
        <address>
          <city>Morgantown</city>
          <state>West Virginia</state>
          <zip>26505</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Camila Vieira Ligo Teixeira, PhD</last_name>
        <phone>304-293-6780</phone>
        <email>camila.vieiraligoteixeira@hsc.wvu.edu</email>
      </contact>
      <investigator>
        <last_name>Marc Haut, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Sleep Quality</keyword>
    <keyword>Photobiomodulation</keyword>
    <keyword>Dry Float</keyword>
    <!-- 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/NCT05963555
  org study id: 2303738136
  nct id: NCT05963555
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  The main objective of this study is to assess the impact of implementing photobiomodulation
        (PBM) therapy, either localized or whole body, or dry float on sleep quality in middle-aged
        and elderly individuals experiencing sleep disturbance. As a secondary objective we will
        analyze the effect of the treatments on other indices of recovery (subjective and objective)
        via physiological monitoring in middle-aged and elderly individuals experiencing sleep
        disturbance.
  
        The study will have 2 phases: Phase 1 will last 5 weeks and will serve as baseline data
        collection of sleep quality. Phase 2 contains the experimental conditions and will last 13
        weeks. Cognitive, behavioral, and physiological tests will be done at baseline (week 1) and
        at the end of experimental period (week 18). Sleep tracking data will be collected daily.
  In summary the study participants are expected to:
  
          -  Wear a study provided smart ring (OURA Ring) through the end of the study period (at
             least 75% of the total study time) which measures sleep quantity/quality.
  
          -  Keep their smart phones nearby and charged while wearing their devices.
  
          -  Complete monthly surveys with questions about general well-being until the end of the
             study period.
  
          -  Complete a testing battery consisting of cognitive tests, behavioral and mood
             questionnaires, qEEG and physical assessments, in the beginning and at the end of the
             study period.
  
          -  Complete the designated experimental condition 2- 3x/week for 12 weeks (at least 75% of
             the total sessions), if applicable.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Changes in resting state electroencephalography (EEG)
  time frame: Changes from baseline versus end of study week 18
  description: Electroencephalography (EEG) analysis looking for alterations in brain activity. A paired samples t-Test will be used to compare power activity at baseline and follow-up.
  measure: Changes in the Patient Health Questionnaire (PHQ-9)
  time frame: Changes from baseline versus end of study week 18
  description: Participants will complete the Patient Health Questionnaire (PHQ-9) once a month. The higher the score, the more severe the symptoms of depression. Scores range from 5-9 = mild, 10-14 = moderate, 15-19 = moderate severe, 20-27 severe depression
  measure: Changes in total sleep via Oura Ring
  time frame: Changes from baseline versus end of study week 18
  description: Oura Ring will be used to track total sleep throughout the study. Increased total sleep values will indicate better quality sleep and decrease total sleep values will indicate poorer sleep.
  measure: Changes in the Circadian Sleep Inventory
  time frame: Changes from baseline versus end of study week 18
  description: Evaluate changes in the participants sleeping patterns. Higher values indicate poorer sleep quality.
  arm group label: Whole-Body Photobiomodulation
  arm group type: Experimental
  description: Light therapy in both the visible and near-infrared range (non-UV) applied to the whole body in a light pod or bed.
  arm group label: Dry Float
  arm group type: Experimental
  description: Simulates the effects of traditional Float-REST therapy. Instead of contact with salt water, the dry float system has a very thin membrane that cradles the body and provides a warm sensation, similar to that experienced in a traditional flotation tank.
  arm group label: Localized Photobiomodulation
  arm group type: Experimental
  description: Light therapy in both the visible and near-infrared range (non-UV) applied locally to only a specific body region.
  arm group label: Control
  arm group type: No Intervention
  description: Participants in the control group will be asked to keep their normal daily routine.
  intervention type: Device
  intervention name: NovoThor
  description: Following the baseline block (first four weeks), participants will use the NovoThor device 2-3 times per week for 20 minute sessions at the WVU Rockefeller Neuroscience Institute.
  arm group label: Whole-Body Photobiomodulation
  intervention type: Device
  intervention name: VieLight
  description: Following the baseline block (first four weeks), participants will use the VieLight device 2-3 times per week for 20 minute sessions and may be completed at home.
  arm group label: Localized Photobiomodulation
  intervention type: Device
  intervention name: ZeroBody
  description: Following the baseline block (first four weeks), participants will use the Zerobody device 2-3 times per week for 20 minute sessions at the WVU Rockefeller Neuroscience Institute.
  arm group label: Dry Float
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Camila Vieira Ligo Teixeira, PhD
  phone: 304-293-6780
  email: camila.vieiraligoteixeira@hsc.wvu.edu
  last name: Carolyn Ferreyra
  phone: 304-293-4944
  email: carolyn.ferreyra@hsc.wvu.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor