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/NCT05971771</url>
    </required_header>
    <id_info>
      <org_study_id>DCS-7-23</org_study_id>
      <nct_id>NCT05971771</nct_id>
    </id_info>
    <brief_title>Study to Assess Impact of Dietary Supplement on Sleep Health</brief_title>
    <official_title>A Randomized, Double-Blind, Placebo Controlled, Single Center Pilot Study to Assess the Impact of Sleep Supplement on Sleep Health</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pharmanex</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Dermatology Consulting Services, High Point NC</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Pharmanex</source>
    <oversight_info>
      <has_dmc>No</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 essential for health and wellness. Sleep disruption can occur due to emotional&#xD;
        stress, advancing age, hormonal imbalance, medications, and many other causes, some of which&#xD;
        are presently unknown. Most pharmaceutical sleep products artificially induce sedation&#xD;
        without providing quality sleep. Thus, a need exists for safe dietary supplement to promote&#xD;
        and support healthy sleep that will encourage restful sleep. This study will examine the&#xD;
        efficacy, tolerance, and safety of sleep supplement as compared to a placebo.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 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>
      <intervention_model_description>A double-blind, placebo controlled, parallel designed study in healthy subjects</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>Products will be delivered in forms that it will not be discernable (to participant, investigator, or care provider) as to which product is active or placebo</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline sleep quality index</measure>
      <time_frame>Baseline, Day 1, Day 7, Day 28</time_frame>
      <description>Change from baseline in validated Pittsburgh Sleep Quality Index (0-21, higher number indicates poorer quality)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change from baseline sleep duration and quality from diary</measure>
      <time_frame>Baseline and Daily for 28 days</time_frame>
      <description>Change from baseline with Daily Sleep Diary</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline perceived stress scale</measure>
      <time_frame>Baseline, Day 1, Day 7, Day 28</time_frame>
      <description>Change from baseline with validated perceived stress questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline Insomnia severity index</measure>
      <time_frame>Baseline, Day 1, Day 7, Day 28</time_frame>
      <description>Change from baseline using validated Insomnia Severity Index (0-28, higher number indicates more severe insomnia)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in restorative sleep as measured by Restorative Sleep Questionnaire (RSQ)</measure>
      <time_frame>Baseline, Day 1, Day 7, Day 28</time_frame>
      <description>Change from baseline using restorative sleep questionnaire as measured by Restorative Sleep Questionnaire (RSQ) that is a 9-item scale/question assessing symptoms over the last week. The total score ranges from 0 to 100, with higher scores indicating better restorative sleep</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in mood</measure>
      <time_frame>Baseline, Day 1, Day 7, Day 28</time_frame>
      <description>Change from baseline using abbreviated Profile of Mood States (POMS) is a widely used questionnaire of 24 items and four scales. Total numbers range from 0-not at all to 4-very strong</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline in skin attributes</measure>
      <time_frame>Baseline, Day 7, and Day 28</time_frame>
      <description>Change from baseline in skin attributes using 1-5 scale (1 strongly disagree to 5 strongly agree) with questionnaire regarding skin appearance (youthfulness, glow, evenness, hydration, etc)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in diastolic blood pressure measurement (safety measure)</measure>
      <time_frame>Baseline and Day 28</time_frame>
      <description>Change from baseline diastolic blood pressure changes using sphygmomanometer</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in systolic blood pressure measurement (safety measure)</measure>
      <time_frame>Baseline and Day 28</time_frame>
      <description>Change from baseline systolic blood pressure changes using sphygmomanometer</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in body weight</measure>
      <time_frame>Baseline and Day Day 28</time_frame>
      <description>change from baseline in body weight as measured in pounds</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Sleep</condition>
    <arm_group>
      <arm_group_label>Active: Sleep Supplement containing Magnesium and Saffron Extract</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Powder that is to be mixed into 3oz. of water, 30-60 minutes before going to bed</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo that is 2 softgels that will be taken with water, 30-60 minutes prior to going to bed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Two softgels to be taken with water that is to be consumed approximately 30-60 minutes before going to bed</description>
      <arm_group_label>Placebo</arm_group_label>
      <other_name>Placebo Supplement</other_name>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Treatment</intervention_name>
      <description>14mg saffron extract and 250mg magnesium citrate that is powder that is mixed in 3-4 oz of water and consumed 30-60 minutes before going to bed</description>
      <arm_group_label>Active: Sleep Supplement containing Magnesium and Saffron Extract</arm_group_label>
      <other_name>Supplement for supporting sleep</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The subject is male or female 20-60 years of age at the time of informed consent.&#xD;
  &#xD;
            -  Recorded baseline BMI is ≥18.5 and ≤29.9 kg/m2.&#xD;
  &#xD;
            -  A score of 5 or higher on the Pittsburgh Sleep Quality Index.&#xD;
  &#xD;
            -  Willing and able to give informed consent&#xD;
  &#xD;
            -  Willing to maintain consistent diet and physical activity through the study period.&#xD;
  &#xD;
            -  Willing to limit alcohol consumption to ≤14 drinks per week, no more than 4 drinks at&#xD;
               a time, and no more than 1 drink within 4h of bedtime.&#xD;
  &#xD;
            -  Willing to limit caffeine consumption to no more than 4 servings per day and no&#xD;
               caffeine within 6h of bedtime.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Could not or did not want to participate in clinical study.&#xD;
  &#xD;
            -  Taken nutritional supplements for sleep or stress in the previous 6 months.&#xD;
  &#xD;
            -  Have received non-pharmacological treatment for sleep disorders (eg. Cognitive&#xD;
               behavioral therapy, relation therapy) in previous 6 months&#xD;
  &#xD;
            -  Any known allergy or intolerance to any of the ingredients contained in supplement.&#xD;
  &#xD;
            -  Planned surgical procedure during the course of the study.&#xD;
  &#xD;
            -  Used nicotine in the past 6 months.&#xD;
  &#xD;
            -  Have a major psychiatric disorder as determined by the Mini International&#xD;
               Neuropsychiatric Inventory&#xD;
  &#xD;
            -  A history of unconventional sleep pattern, a diagnosed sleep disorder, or chronic&#xD;
               medical condition that could affect energy/fatigue levels.&#xD;
  &#xD;
            -  Consume more than 400mg of caffeine per day in the past 2 weeks.&#xD;
  &#xD;
            -  Used any psychotropic medications, stimulants, cannabis, non-registered drug products,&#xD;
               or illicit substances in the past 4 weeks.&#xD;
  &#xD;
            -  At risk of drug or alcohol abuse&#xD;
  &#xD;
            -  Used any sleep aids in the past 2 weeks.&#xD;
  &#xD;
            -  Employed in night shift work or rotational shift work&#xD;
  &#xD;
            -  Currently pregnant, nursing, planning to become pregnant, or unwilling to use a&#xD;
               medically approved form of contraception will be excluded.&#xD;
  &#xD;
            -  Individuals who sleep more than 10 hours.&#xD;
  &#xD;
            -  Typically take a nap during the day.&#xD;
  &#xD;
            -  Those planning travel or vacation during the study period.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zoe D Diana, MD</last_name>
      <phone>336-841-2040</phone>
      <email>zdraelos@northstate.net</email>
    </overall_contact>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Sleep</keyword>
    <keyword>Alertness</keyword>
    <keyword>Restfulness</keyword>
    <keyword>Dietary AND Supplement</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05971771
  org study id: DCS-7-23
  nct id: NCT05971771
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Sleep is essential for health and wellness. Sleep disruption can occur due to emotional
        stress, advancing age, hormonal imbalance, medications, and many other causes, some of which
        are presently unknown. Most pharmaceutical sleep products artificially induce sedation
        without providing quality sleep. Thus, a need exists for safe dietary supplement to promote
        and support healthy sleep that will encourage restful sleep. This study will examine the
        efficacy, tolerance, and safety of sleep supplement as compared to a placebo.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A double-blind, placebo controlled, parallel designed study in healthy subjects
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: Products will be delivered in forms that it will not be discernable (to participant, investigator, or care provider) as to which product is active or placebo
  measure: Change from baseline sleep quality index
  time frame: Baseline, Day 1, Day 7, Day 28
  description: Change from baseline in validated Pittsburgh Sleep Quality Index (0-21, higher number indicates poorer quality)
  measure: Change from baseline sleep duration and quality from diary
  time frame: Baseline and Daily for 28 days
  description: Change from baseline with Daily Sleep Diary
  measure: Change from baseline perceived stress scale
  time frame: Baseline, Day 1, Day 7, Day 28
  description: Change from baseline with validated perceived stress questionnaire
  measure: Change from baseline Insomnia severity index
  time frame: Baseline, Day 1, Day 7, Day 28
  description: Change from baseline using validated Insomnia Severity Index (0-28, higher number indicates more severe insomnia)
  measure: Change from baseline in restorative sleep as measured by Restorative Sleep Questionnaire (RSQ)
  time frame: Baseline, Day 1, Day 7, Day 28
  description: Change from baseline using restorative sleep questionnaire as measured by Restorative Sleep Questionnaire (RSQ) that is a 9-item scale/question assessing symptoms over the last week. The total score ranges from 0 to 100, with higher scores indicating better restorative sleep
  measure: Change from baseline in mood
  time frame: Baseline, Day 1, Day 7, Day 28
  description: Change from baseline using abbreviated Profile of Mood States (POMS) is a widely used questionnaire of 24 items and four scales. Total numbers range from 0-not at all to 4-very strong
  measure: Change from baseline in skin attributes
  time frame: Baseline, Day 7, and Day 28
  description: Change from baseline in skin attributes using 1-5 scale (1 strongly disagree to 5 strongly agree) with questionnaire regarding skin appearance (youthfulness, glow, evenness, hydration, etc)
  measure: Change in diastolic blood pressure measurement (safety measure)
  time frame: Baseline and Day 28
  description: Change from baseline diastolic blood pressure changes using sphygmomanometer
  measure: Change in systolic blood pressure measurement (safety measure)
  time frame: Baseline and Day 28
  description: Change from baseline systolic blood pressure changes using sphygmomanometer
  measure: Change in body weight
  time frame: Baseline and Day Day 28
  description: change from baseline in body weight as measured in pounds
  arm group label: Active: Sleep Supplement containing Magnesium and Saffron Extract
  arm group type: Experimental
  description: Powder that is to be mixed into 3oz. of water, 30-60 minutes before going to bed
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo that is 2 softgels that will be taken with water, 30-60 minutes prior to going to bed.
  intervention type: Other
  intervention name: Placebo
  description: Two softgels to be taken with water that is to be consumed approximately 30-60 minutes before going to bed
  arm group label: Placebo
  other name: Placebo Supplement
  intervention type: Dietary Supplement
  intervention name: Treatment
  description: 14mg saffron extract and 250mg magnesium citrate that is powder that is mixed in 3-4 oz of water and consumed 30-60 minutes before going to bed
  arm group label: Active: Sleep Supplement containing Magnesium and Saffron Extract
  other name: Supplement for supporting sleep
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Zoe D Diana, MD
  phone: 336-841-2040
  email: zdraelos@northstate.net
  responsible party type: Sponsor
  sharing ipd: No