<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/NCT04467268</url>
  </required_header>
  <id_info>
    <org_study_id>LBO-SSEHS-SE_IH</org_study_id>
    <nct_id>NCT04467268</nct_id>
  </id_info>
  <brief_title>Sleep Extension for Metabolic Health</brief_title>
  <official_title>Sleep Extension in Overweight Short Sleepers: A Randomised Controlled Trial:</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loughborough University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospitals, Leicester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Leicester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Loughborough University</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>
      The study aims to examine the effects of a sleep extension intervention on the metabolic and&#xD;
      cardio-vascular profile of obese people who present traditional diabetes risk factors, and&#xD;
      who are habitually sleep deprived. Participants randomized to the intervention arm will&#xD;
      complete a 6-week sleep extension intervention, whilst the control group will maintain their&#xD;
      habitual sleep schedule. It is hypothesized that the sleep extension intervention will&#xD;
      significantly increase total sleep time, and will be accompanied by significant&#xD;
      metabolic-related changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent epidemiological (survey) research, conducted in both in healthy populations and among&#xD;
      those with existing chronic disease, shows that insufficient sleep can significantly&#xD;
      contribute to ill health (including diabetes, heart disease and obesity). These findings have&#xD;
      also been accompanied by credible explanatory mechanisms emphasising the role of sleep in&#xD;
      regulating appetite, satiety, glucose and daytime stamina. Sleep extension, therefore, is a&#xD;
      largely unexplored pathway for improving individual health, and reducing an existing risk of&#xD;
      diabetes. If successful, increased sleep duration and quality could be adopted as an&#xD;
      achievable public health intervention.&#xD;
&#xD;
      The study aims to recruit a total of 20 men, overweight, presenting traditional risks of&#xD;
      developing diabetes, who are habitually short sleepers. Participants are then randomized,&#xD;
      stratified by weight status, to a sleep extension group, or a control sleep monitoring group.&#xD;
      Baseline measures include sleep actigraphy, continuous glucose monitoring, blood pressure,&#xD;
      and a mixed-meal tolerance test; after the 6-week intervention, the same measures are&#xD;
      repeated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2017</start_date>
  <completion_date type="Actual">April 15, 2018</completion_date>
  <primary_completion_date type="Actual">April 15, 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>
    <intervention_model_description>Randomized controlled trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Blood samples outcome assessor was blinded to group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total sleep time (TST)</measure>
    <time_frame>24 hours</time_frame>
    <description>Time asleep obtained every night, as measured by actigraphy (minutes).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time in Bed (TIB)</measure>
    <time_frame>24 hours</time_frame>
    <description>Time between getting into and getting out of bed (minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep onset latency (SOL)</measure>
    <time_frame>24 hours</time_frame>
    <description>Time to fall asleep (minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wake after sleep onset (WASO)</measure>
    <time_frame>24 hours</time_frame>
    <description>Time awake after the first sleep period (minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose concentration</measure>
    <time_frame>3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes</time_frame>
    <description>Total area under the glucose concentration curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin concentration</measure>
    <time_frame>3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes</time_frame>
    <description>Total area under the insulin concentration curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total PYY concentration</measure>
    <time_frame>3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes</time_frame>
    <description>Total area under the PYY concentration curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grelin concentration</measure>
    <time_frame>3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes</time_frame>
    <description>Total area under the ghrelin concentration curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Leptin concentration</measure>
    <time_frame>8-hour fasting blood samples</time_frame>
    <description>Fasting leptin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minutes per 24 hours of Moderate to vigorous physical activity (MVPA)</measure>
    <time_frame>24 hours</time_frame>
    <description>Physical activity recorded with actigraphs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard Deviation of Blood Glucose Standard Deviation of Blood Glucose</measure>
    <time_frame>14 days</time_frame>
    <description>Obtained from all CGMs 24-hour blood glucose concentrations across the monitoring period with</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Amplitude of Glycemic Excursions</measure>
    <time_frame>24 hours</time_frame>
    <description>Mean blood glucose values exceeding one standard deviation of the 24-hour arithmetic average across the monitoring period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic and diastolic blood pressure</measure>
    <time_frame>10 minutes</time_frame>
    <description>Measurements of arterial blood pressure were taken, each after resting in a supine position for 10 minutes in a fasting state</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Sleep Quality Index</measure>
    <time_frame>One month</time_frame>
    <description>Self-reported measure of sleep quality, score range 0-21,higher scores indicate worse sleep quality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Assessment of Fatigue</measure>
    <time_frame>One week</time_frame>
    <description>Self-reported assessment of experienced fatigue, scores range from 1 to 50, higher scores indicate worse fatigue.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Short Sleep</condition>
  <arm_group>
    <arm_group_label>Sleep extension intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group participants met with an experienced sleep scientist to discuss and agree changes to their sleep and personal schedules. Discussions lasted 60-90 minutes, were informed by actigraphic sleep assessments from the baseline period, and aimed to increase TST by ≥1 hour/night. The structure and content of the &quot;About Sleep&quot;, &quot;Sleep Hygiene&quot; and &quot;Thoughts and Sleep&quot; components of the online Sleepful application, a self-help sleep management programme. Advice was supported by the provision of self-help booklets addressing sleep hygiene and the management of pre-sleep cognitions which had been successfully trailed in an intervention for insomnia symptoms. Finally, to capitalize on the participant's motivation at recruitment, and optimize adherence, the newly agreed sleep schedule was written into an agreement which the participant was asked to sign, simulating a 'therapeutic contract'. Schedules were reviewed by telephone at the end of the first week and revised if required.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group were asked to continue with their habitual sleep schedule.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep extension</intervention_name>
    <description>The sleep extension programme was designed around four alternative assumptions: 1) that among this group of habitual short sleepers, extending time in bed (TIB) would represent a significant behavioral change to established night-time and daytime routines; 2) that for practical purposes (accommodating personal, family and work schedules) extended time in bed is best anchored against typical rise-times; 3) that sleep onset may represent a particular challenge for those advancing habitual bed-times by over 1 hour each night; and 4) that in consenting to the trial, participants were motivated to make and sustain behavioral change.</description>
    <arm_group_label>Sleep extension intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 25 to 55 years (inclusive)&#xD;
&#xD;
          -  Gender: Men&#xD;
&#xD;
          -  BMI &gt; 25kg/m2&#xD;
&#xD;
          -  Average self-reported sleep duration of ≤ 6h per 24h&#xD;
&#xD;
          -  Stable daily sleep/wake schedule&#xD;
&#xD;
          -  Health risk screening score ≥ 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed sleep disorder as per DSM-5: e.g. insomnia, restless legs syndrome,&#xD;
             moderate/severe Obstructive Sleep Apnoea; Epworth Sleepiness Score: &lt;5&#xD;
&#xD;
          -  Diagnosed chronic conditions, or medication, likely to interfere with regular sleep:&#xD;
             T2D, chronic fatigue syndrome, fibromyalgia, COPD, uncontrolled depression/anxiety,&#xD;
             other severe psychiatric illness, substance abuse.&#xD;
&#xD;
          -  Night/evening shift work , regular time-zone travel, other circumstances preventing&#xD;
             regular sleep schedule (e.g. very young children, carer at night for sick relatives&#xD;
             etc)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Iuliana Hartescu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loughborough University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loughborough University</name>
      <address>
        <city>Loughborough</city>
        <zip>LE11 3TU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loughborough University</investigator_affiliation>
    <investigator_full_name>Dr Iuliana Hartescu</investigator_full_name>
    <investigator_title>Lecturer in Psychology</investigator_title>
  </responsible_party>
  <keyword>short sleep</keyword>
  <keyword>insufficient sleep</keyword>
  <keyword>sleep extension</keyword>
  <keyword>diabetes risk</keyword>
  <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/NCT04467268
org study id: LBO-SSEHS-SE_IH
nct id: NCT04467268
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to examine the effects of a sleep extension intervention on the metabolic and
      cardio-vascular profile of obese people who present traditional diabetes risk factors, and
      who are habitually sleep deprived. Participants randomized to the intervention arm will
      complete a 6-week sleep extension intervention, whilst the control group will maintain their
      habitual sleep schedule. It is hypothesized that the sleep extension intervention will
      significantly increase total sleep time, and will be accompanied by significant
      metabolic-related changes.
Recent epidemiological (survey) research, conducted in both in healthy populations and among
      those with existing chronic disease, shows that insufficient sleep can significantly
      contribute to ill health (including diabetes, heart disease and obesity). These findings have
      also been accompanied by credible explanatory mechanisms emphasising the role of sleep in
      regulating appetite, satiety, glucose and daytime stamina. Sleep extension, therefore, is a
      largely unexplored pathway for improving individual health, and reducing an existing risk of
      diabetes. If successful, increased sleep duration and quality could be adopted as an
      achievable public health intervention.

      The study aims to recruit a total of 20 men, overweight, presenting traditional risks of
      developing diabetes, who are habitually short sleepers. Participants are then randomized,
      stratified by weight status, to a sleep extension group, or a control sleep monitoring group.
      Baseline measures include sleep actigraphy, continuous glucose monitoring, blood pressure,
      and a mixed-meal tolerance test; after the 6-week intervention, the same measures are
      repeated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Blood samples outcome assessor was blinded to group allocation.
measure: Total sleep time (TST)
time frame: 24 hours
description: Time asleep obtained every night, as measured by actigraphy (minutes).
measure: Time in Bed (TIB)
time frame: 24 hours
description: Time between getting into and getting out of bed (minutes)
measure: Sleep onset latency (SOL)
time frame: 24 hours
description: Time to fall asleep (minutes)
measure: Wake after sleep onset (WASO)
time frame: 24 hours
description: Time awake after the first sleep period (minutes)
measure: Glucose concentration
time frame: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
description: Total area under the glucose concentration curve
measure: Insulin concentration
time frame: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
description: Total area under the insulin concentration curve
measure: Total PYY concentration
time frame: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
description: Total area under the PYY concentration curve
measure: Grelin concentration
time frame: 3-hour mixed meal tolerance test blood plasma samples: prior to the test meal (0 minutes), and at 30, 60, 90, 120, 150, and 180 minutes
description: Total area under the ghrelin concentration curve
measure: Leptin concentration
time frame: 8-hour fasting blood samples
description: Fasting leptin levels
measure: Minutes per 24 hours of Moderate to vigorous physical activity (MVPA)
time frame: 24 hours
description: Physical activity recorded with actigraphs
measure: Standard Deviation of Blood Glucose Standard Deviation of Blood Glucose
time frame: 14 days
description: Obtained from all CGMs 24-hour blood glucose concentrations across the monitoring period with
measure: Mean Amplitude of Glycemic Excursions
time frame: 24 hours
description: Mean blood glucose values exceeding one standard deviation of the 24-hour arithmetic average across the monitoring period
measure: Systolic and diastolic blood pressure
time frame: 10 minutes
description: Measurements of arterial blood pressure were taken, each after resting in a supine position for 10 minutes in a fasting state
measure: Pittsburgh Sleep Quality Index
time frame: One month
description: Self-reported measure of sleep quality, score range 0-21,higher scores indicate worse sleep quality.
measure: Multidimensional Assessment of Fatigue
time frame: One week
description: Self-reported assessment of experienced fatigue, scores range from 1 to 50, higher scores indicate worse fatigue.
arm group label: Sleep extension intervention
arm group type: Experimental
description: Intervention group participants met with an experienced sleep scientist to discuss and agree changes to their sleep and personal schedules. Discussions lasted 60-90 minutes, were informed by actigraphic sleep assessments from the baseline period, and aimed to increase TST by ≥1 hour/night. The structure and content of the "About Sleep", "Sleep Hygiene" and "Thoughts and Sleep" components of the online Sleepful application, a self-help sleep management programme. Advice was supported by the provision of self-help booklets addressing sleep hygiene and the management of pre-sleep cognitions which had been successfully trailed in an intervention for insomnia symptoms. Finally, to capitalize on the participant's motivation at recruitment, and optimize adherence, the newly agreed sleep schedule was written into an agreement which the participant was asked to sign, simulating a 'therapeutic contract'. Schedules were reviewed by telephone at the end of the first week and revised if required.
arm group label: Control group
arm group type: No Intervention
description: Participants in the control group were asked to continue with their habitual sleep schedule.
intervention type: Behavioral
intervention name: Sleep extension
description: The sleep extension programme was designed around four alternative assumptions: 1) that among this group of habitual short sleepers, extending time in bed (TIB) would represent a significant behavioral change to established night-time and daytime routines; 2) that for practical purposes (accommodating personal, family and work schedules) extended time in bed is best anchored against typical rise-times; 3) that sleep onset may represent a particular challenge for those advancing habitual bed-times by over 1 hour each night; and 4) that in consenting to the trial, participants were motivated to make and sustain behavioral change.
arm group label: Sleep extension intervention
criteria: 
gender: Male
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Iuliana Hartescu, PhD
role: Principal Investigator
affiliation: Loughborough University
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Loughborough University
investigator full name: Dr Iuliana Hartescu
investigator title: Lecturer in Psychology
sharing ipd: No