<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/NCT03037554</url>
  </required_header>
  <id_info>
    <org_study_id>Lateralized Thermal Sleepwear</org_study_id>
    <nct_id>NCT03037554</nct_id>
  </id_info>
  <brief_title>The Effects of Lateralized Thermal Sleepwear on Sleep, Skin Temperature and Skin Moisture in Menopausal Women</brief_title>
  <official_title>The Effects of Sleepwear With Lateralized Thermal Characteristics on Sleep, Proximal Skin Temperature and Sternal Skin Moisture in Menopausal Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Peter's Hospital, Albany, NY</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Peter's Hospital, Albany, NY</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>
      A home-based, sham-controlled, double-blind, crossover study evaluating the effects of&#xD;
      wearing sleepwear with lateralized thermal characteristics on subjective and objective sleep&#xD;
      measures, proximal skin temperature, and sternal skin moisture in menopausal women&#xD;
      complaining of sleep disturbance and vasomotor symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixteen menopausal women who have given informed consent to participate will be medically&#xD;
      screened to rule out physiological sleep disorders. Sleep schedules will be regulated to the&#xD;
      average bedtime of a two-week baseline sleep log. Subjects will undergo two two-night,&#xD;
      home-based monitoring phases, one an experimental and one a control condition, separated by a&#xD;
      washout period of at least five nights. The order of conditions will be counterbalanced&#xD;
      between subjects in double-blind fashion. In the experimental condition subjects will wear&#xD;
      sleepwear constructed of two fabric types arranged bilaterally, with typical cotton spandex&#xD;
      insulating material on one side and specialized conductive material on the other. In the&#xD;
      control condition subjects will wear sleepwear that is similarly lateralized in terms of&#xD;
      appearance but constructed with typical cotton spandex insulating material on both sides.&#xD;
      Ambulatory monitoring will include body position, EEG, actigraphy, skin temperature at&#xD;
      multiple proximal sites, and sternal skin moisture. Subjective scales of insomnia severity,&#xD;
      menopausal symptoms and sleepwear rating will also be employed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Technical difficulties with ambulatory equipment led to unacceptably high levels of data loss.&#xD;
    As we would have had to suspend data collection under Covid precautions in any case, we decided&#xD;
    to terminate in March of this year.&#xD;
  </why_stopped>
  <start_date type="Actual">May 21, 2017</start_date>
  <completion_date type="Actual">March 15, 2020</completion_date>
  <primary_completion_date type="Actual">March 15, 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Hierarchical linear model evaluating repeated measures nested within subjects</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Treatment and sham-control sleepwear will be allocated to subjects in a counterbalanced manner by a study administrator who will not otherwise interact with subjects.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total Sleep Time</measure>
    <time_frame>Two nights in the experimental condition and two nights in the control condition.</time_frame>
    <description>Minutes of sleep of any stage, as scored by conventional criteria, across recording period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wakefulness After Sleep Onset</measure>
    <time_frame>Two nights in the experimental condition and two nights in the control condition.</time_frame>
    <description>Minutes of Wakefulness, as scored by conventional criteria, from first epoch of sleep until end of recording period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Minutes of non-rapid eye movement (NREM) Stage 1 Sleep</measure>
    <time_frame>Two nights in the experimental condition and two nights in the control condition.</time_frame>
    <description>Minutes of NREM Stage 1 Sleep, as scored by conventional criteria, across recording period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proximal Skin Temperature</measure>
    <time_frame>Measurements taken every 90 seconds across two-night experimental and control conditions</time_frame>
    <description>Thermochron iButton-derived measurements of skin temperature at bilateral Infraclavicular, Lateral Abdominal and Vastus Lateralis sites</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Position Monitoring</measure>
    <time_frame>Position sampled every two seconds across two nights in experimental condition and two nights in control condition</time_frame>
    <description>Sleep position recorded by iPhone-based SomnoPose app</description>
  </other_outcome>
  <other_outcome>
    <measure>Sternal Skin Moisture</measure>
    <time_frame>Measurements taken every three minutes across two nights in experimental condition and two nights in control condition</time_frame>
    <description>Skin humidity at sternum recorded by specialized Thermochron iButton</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Menopause Related Conditions</condition>
  <arm_group>
    <arm_group_label>Lateralized Thermal Sleepwear</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For two consecutive nights subjects will wear Sleepwear with Lateralized Thermal Characteristics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham-Lateralized Sleepwear</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>For two consecutive nights subjects will wear Sham-Lateralized Sleepwear</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sleepwear with Lateralized Thermal Characteristics</intervention_name>
    <description>Subjects will wear sleepwear constructed with insulating fabric on one side and conductive fabric on the other side, arranged bilaterally.</description>
    <arm_group_label>Lateralized Thermal Sleepwear</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham-Lateralized Sleepwear</intervention_name>
    <description>Subjects will wear sleepwear constructed with two insulating fabrics arranged bilaterally.</description>
    <arm_group_label>Sham-Lateralized Sleepwear</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 12 months since last menstrual period&#xD;
&#xD;
          -  Subjective complaint of sleep disturbance, confirmed by Pittsburgh Sleep Quality Index&#xD;
             score greater than 5&#xD;
&#xD;
          -  Subjective complaint of at least moderate symptoms of menopause, confirmed by modified&#xD;
             Kupperman score greater than 15&#xD;
&#xD;
          -  Ability to sleep in the left lateral, right lateral and supine positions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to taper off, with health care provider's agreement, hypnotic or sedative&#xD;
             medications, hormone replacement therapy, clonidine, gabapentin, or isoflavones and&#xD;
             other botanical compounds used to treat vasomotor symptoms of menopause&#xD;
&#xD;
          -  Unable to taper to two or fewer caffeinated beverages per day&#xD;
&#xD;
          -  Unable to taper to one or fewer alcoholic beverages per day&#xD;
&#xD;
          -  Unable to taper off nicotine in any form&#xD;
&#xD;
          -  Unable to taper off recreational drugs&#xD;
&#xD;
          -  Subjective sleep, based on two-week sleep logs, averaging less than 4.0 or greater&#xD;
             than 7.5 hours per night&#xD;
&#xD;
          -  Clinical suspicion of obstructive sleep apnea, periodic leg movements or other&#xD;
             significant physiological sleep disturbance&#xD;
&#xD;
          -  Known skin allergy to silver, cotton, nylon, surgical tape and other adhesives&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Glovinsky, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Peter's Sleep Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Peter's Sleep Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>March 26, 2021</last_update_submitted>
  <last_update_submitted_qc>March 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Peter's Hospital, Albany, NY</investigator_affiliation>
    <investigator_full_name>Paul Glovinsky, Ph.D.</investigator_full_name>
    <investigator_title>Clinical Director, St. Peter's Sleep Center</investigator_title>
  </responsible_party>
  <keyword>Skin Temperature</keyword>
  <keyword>Hot Flashes</keyword>
  <keyword>Sleep Disturbance</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/NCT03037554
org study id: Lateralized Thermal Sleepwear
nct id: NCT03037554
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A home-based, sham-controlled, double-blind, crossover study evaluating the effects of
      wearing sleepwear with lateralized thermal characteristics on subjective and objective sleep
      measures, proximal skin temperature, and sternal skin moisture in menopausal women
      complaining of sleep disturbance and vasomotor symptoms.
Sixteen menopausal women who have given informed consent to participate will be medically
      screened to rule out physiological sleep disorders. Sleep schedules will be regulated to the
      average bedtime of a two-week baseline sleep log. Subjects will undergo two two-night,
      home-based monitoring phases, one an experimental and one a control condition, separated by a
      washout period of at least five nights. The order of conditions will be counterbalanced
      between subjects in double-blind fashion. In the experimental condition subjects will wear
      sleepwear constructed of two fabric types arranged bilaterally, with typical cotton spandex
      insulating material on one side and specialized conductive material on the other. In the
      control condition subjects will wear sleepwear that is similarly lateralized in terms of
      appearance but constructed with typical cotton spandex insulating material on both sides.
      Ambulatory monitoring will include body position, EEG, actigraphy, skin temperature at
      multiple proximal sites, and sternal skin moisture. Subjective scales of insomnia severity,
      menopausal symptoms and sleepwear rating will also be employed.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Hierarchical linear model evaluating repeated measures nested within subjects
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Treatment and sham-control sleepwear will be allocated to subjects in a counterbalanced manner by a study administrator who will not otherwise interact with subjects.
measure: Total Sleep Time
time frame: Two nights in the experimental condition and two nights in the control condition.
description: Minutes of sleep of any stage, as scored by conventional criteria, across recording period.
measure: Wakefulness After Sleep Onset
time frame: Two nights in the experimental condition and two nights in the control condition.
description: Minutes of Wakefulness, as scored by conventional criteria, from first epoch of sleep until end of recording period.
measure: Minutes of non-rapid eye movement (NREM) Stage 1 Sleep
time frame: Two nights in the experimental condition and two nights in the control condition.
description: Minutes of NREM Stage 1 Sleep, as scored by conventional criteria, across recording period.
measure: Proximal Skin Temperature
time frame: Measurements taken every 90 seconds across two-night experimental and control conditions
description: Thermochron iButton-derived measurements of skin temperature at bilateral Infraclavicular, Lateral Abdominal and Vastus Lateralis sites
measure: Position Monitoring
time frame: Position sampled every two seconds across two nights in experimental condition and two nights in control condition
description: Sleep position recorded by iPhone-based SomnoPose app
measure: Sternal Skin Moisture
time frame: Measurements taken every three minutes across two nights in experimental condition and two nights in control condition
description: Skin humidity at sternum recorded by specialized Thermochron iButton
arm group label: Lateralized Thermal Sleepwear
arm group type: Experimental
description: For two consecutive nights subjects will wear Sleepwear with Lateralized Thermal Characteristics
arm group label: Sham-Lateralized Sleepwear
arm group type: Sham Comparator
description: For two consecutive nights subjects will wear Sham-Lateralized Sleepwear
intervention type: Device
intervention name: Sleepwear with Lateralized Thermal Characteristics
description: Subjects will wear sleepwear constructed with insulating fabric on one side and conductive fabric on the other side, arranged bilaterally.
arm group label: Lateralized Thermal Sleepwear
intervention type: Device
intervention name: Sham-Lateralized Sleepwear
description: Subjects will wear sleepwear constructed with two insulating fabrics arranged bilaterally.
arm group label: Sham-Lateralized Sleepwear
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 69 Years
healthy volunteers: No
last name: Paul Glovinsky, Ph.D.
role: Principal Investigator
affiliation: St. Peter's Sleep Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: St. Peter's Hospital, Albany, NY
investigator full name: Paul Glovinsky, Ph.D.
investigator title: Clinical Director, St. Peter's Sleep Center
sharing ipd: No