<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/NCT03255746</url>
  </required_header>
  <id_info>
    <org_study_id>17-004044</org_study_id>
    <secondary_id>R01HL134808</secondary_id>
    <nct_id>NCT03255746</nct_id>
  </id_info>
  <brief_title>HELP-HY: Health Education and sLeep Program in HYpertension</brief_title>
  <official_title>HELP-HY: Health Education and sLeep Program in HYpertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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>
      Hypertension is the major risk factor for cardiovascular and cerebrovascular diseases&#xD;
      worldwide. The escalating prevalence of inadequate sleep now parallels that of hypertension.&#xD;
      Observational and experimental evidence favoring a causal relation between insufficient sleep&#xD;
      and hypertension are particularly compelling - sleeping 6 hours or less per night is&#xD;
      associated with a 20-32% higher probability of incident hypertension. Since sleep curtailment&#xD;
      is largely voluntary, sleep deficiency may be corrected and the detrimental health&#xD;
      consequences potentially reversed.&#xD;
&#xD;
      In this study the investigators aim to investigate the effects of 8 weeks of sleep&#xD;
      enhancement/extension vs health education in prehypertensive and stage 1 hypertensive&#xD;
      subjects who report habitual short sleep (≤6.5 hours/night).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 19, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in 48-hour mean arterial pressure</measure>
    <time_frame>8 weeks</time_frame>
    <description>changes in ambulatory measure of blood pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in 48-hour heart rate</measure>
    <time_frame>8 weeks</time_frame>
    <description>changes in 24-hour heart rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in baroreflex sensitivity</measure>
    <time_frame>8 weeks</time_frame>
    <description>changes in baroreflex sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in endothelial function</measure>
    <time_frame>8 weeks</time_frame>
    <description>changes in endothelial function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in renin</measure>
    <time_frame>8 weeks</time_frame>
    <description>changes in renin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in angiotensin peptides</measure>
    <time_frame>8 weeks</time_frame>
    <description>changes in angiotensin peptides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in aldosterone</measure>
    <time_frame>8 weeks</time_frame>
    <description>changes in aldosterone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in insulin sensitivity</measure>
    <time_frame>8 weeks</time_frame>
    <description>changes in insulin sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in cortisol</measure>
    <time_frame>8 weeks</time_frame>
    <description>changes in cortisol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in body fat</measure>
    <time_frame>8 weeks</time_frame>
    <description>changes in body fat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in catecholamines</measure>
    <time_frame>8 weeks</time_frame>
    <description>changes in catecholamines</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Prehypertension</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Sleep Enhancement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Health Education</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Enhancement</intervention_name>
    <description>This regimen combines education and behavioral skills to enable prolonging sleep in chronically sleep deprived subjects so as to better meet participant's sleep needs. This intervention emphasizes plain language communication of cognitive behavioral therapy strategies for initiating and maintaining health behavior change, primarily through using brief action plans (time-limited, personally relevant, behavioral goal setting with confidence), and collaborative problem-solving. Coaching will be provided to modify daily routines and adhere to sleep hygiene practices to allow for extended time in bed.</description>
    <arm_group_label>Sleep Enhancement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health Education</intervention_name>
    <description>This is a placebo/attention control condition. Participants will receive health education based on NIH information. Number, duration, and frequency of sessions will be identical to those administered to the intervention group.</description>
    <arm_group_label>Health Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Age: 18 to 65 (inclusive)&#xD;
&#xD;
          -  Gender: both males and females&#xD;
&#xD;
          -  Body mass index (BMI): 18.5-34.9 kg/m2&#xD;
&#xD;
          -  Habitual sleep duration &lt;7 hours and voluntary prolongation of sleep when&#xD;
             circumstances allow (as indicated by napping and/or &gt;45 min catch-up sleep during&#xD;
             weekends or holidays)&#xD;
&#xD;
          -  Presence of prehypertension (office systolic BP (SBP) 120-139 mmHg and/or diastolic BP&#xD;
             (DBP) 80-89 mmHg) , Stage 1 hypertension (office SBP 140-159 mmHg and/or DBP 90-99&#xD;
             mmHg ) , or currently taking antihypertensive medications&#xD;
&#xD;
          -  Either on no prescription medications (other than oral contraceptive pills, or&#xD;
             intrauterine devices) or on stable medical regimen for at least 1 month, if taking&#xD;
             prescription medications for chronic conditions&#xD;
&#xD;
          -  Not pregnant or breast feeding and not intending to become pregnant or breast feed&#xD;
&#xD;
          -  Not a current smoker or tobacco user&#xD;
&#xD;
          -  Ability to provide written informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Vulnerable study populations will be excluded&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Smoking&#xD;
&#xD;
          -  Shift-work&#xD;
&#xD;
          -  Travel across &gt;2 time zones in the previous month&#xD;
&#xD;
          -  Presence of overt cardiovascular diseases, diabetes, chronic kidney disease, cancer,&#xD;
             sleep/circadian disorders, psychiatric disorders&#xD;
&#xD;
          -  If taking prescription medications for chronic conditions, change in therapy (type,&#xD;
             frequency and/or dosage) over the previous month&#xD;
&#xD;
          -  Sleep aids&#xD;
&#xD;
          -  Habitual sleep duration ≥7 hours&#xD;
&#xD;
          -  Excessive alcohol (&gt;14 drinks/week in men and &gt;7 drinks/week in women) and/or&#xD;
             excessive caffeine intake (&gt;400 mg)&#xD;
&#xD;
          -  Currently on a diet and/or actively trying to lose weight&#xD;
&#xD;
          -  History of drowsing driving&#xD;
&#xD;
          -  Severe daytime sleepiness (score &gt;15 at the Epworth Sleepiness Scale)&#xD;
&#xD;
          -  Current or previous (during the past 2 months) participation in other research studies&#xD;
             at the discretion of study personnel&#xD;
&#xD;
          -  Blood/plasma donation during the past 2 months&#xD;
&#xD;
          -  Unwillingness or inability to adjust sleep schedule&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Virend Somers, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Madeline Reid</last_name>
    <phone>507-255-0007</phone>
    <email>CPLSLEEPEXT@mayo.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Naima Covassin, PhD</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 2, 2023</last_update_submitted>
  <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Virend Somers, MD, PhD</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Prehypertension</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/NCT03255746
org study id: 17-004044
secondary id: R01HL134808
nct id: NCT03255746
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypertension is the major risk factor for cardiovascular and cerebrovascular diseases
      worldwide. The escalating prevalence of inadequate sleep now parallels that of hypertension.
      Observational and experimental evidence favoring a causal relation between insufficient sleep
      and hypertension are particularly compelling - sleeping 6 hours or less per night is
      associated with a 20-32% higher probability of incident hypertension. Since sleep curtailment
      is largely voluntary, sleep deficiency may be corrected and the detrimental health
      consequences potentially reversed.

      In this study the investigators aim to investigate the effects of 8 weeks of sleep
      enhancement/extension vs health education in prehypertensive and stage 1 hypertensive
      subjects who report habitual short sleep (≤6.5 hours/night).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: change in 48-hour mean arterial pressure
time frame: 8 weeks
description: changes in ambulatory measure of blood pressure
measure: changes in 48-hour heart rate
time frame: 8 weeks
description: changes in 24-hour heart rate
measure: changes in baroreflex sensitivity
time frame: 8 weeks
description: changes in baroreflex sensitivity
measure: changes in endothelial function
time frame: 8 weeks
description: changes in endothelial function
measure: changes in renin
time frame: 8 weeks
description: changes in renin
measure: changes in angiotensin peptides
time frame: 8 weeks
description: changes in angiotensin peptides
measure: changes in aldosterone
time frame: 8 weeks
description: changes in aldosterone
measure: changes in insulin sensitivity
time frame: 8 weeks
description: changes in insulin sensitivity
measure: changes in cortisol
time frame: 8 weeks
description: changes in cortisol
measure: changes in body fat
time frame: 8 weeks
description: changes in body fat
measure: changes in catecholamines
time frame: 8 weeks
description: changes in catecholamines
arm group label: Sleep Enhancement
arm group type: Experimental
arm group label: Health Education
arm group type: Placebo Comparator
intervention type: Behavioral
intervention name: Sleep Enhancement
description: This regimen combines education and behavioral skills to enable prolonging sleep in chronically sleep deprived subjects so as to better meet participant's sleep needs. This intervention emphasizes plain language communication of cognitive behavioral therapy strategies for initiating and maintaining health behavior change, primarily through using brief action plans (time-limited, personally relevant, behavioral goal setting with confidence), and collaborative problem-solving. Coaching will be provided to modify daily routines and adhere to sleep hygiene practices to allow for extended time in bed.
arm group label: Sleep Enhancement
intervention type: Behavioral
intervention name: Health Education
description: This is a placebo/attention control condition. Participants will receive health education based on NIH information. Number, duration, and frequency of sessions will be identical to those administered to the intervention group.
arm group label: Health Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Virend Somers, MD, PhD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Madeline Reid
phone: 507-255-0007
email: CPLSLEEPEXT@mayo.edu
last name: Naima Covassin, PhD
facility: 
status: Recruiting
country: United States
url: http://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Virend Somers, MD, PhD
investigator title: Professor of Medicine
mesh term: Hypertension
mesh term: Prehypertension
sharing ipd: No