<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/NCT04485728</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-2020-83</org_study_id>
    <nct_id>NCT04485728</nct_id>
  </id_info>
  <brief_title>Sleep Improvement Intervention for Hospitalized Antepartum Patients</brief_title>
  <official_title>Sleep Improvement Intervention for Hospitalized Antepartum Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sam Houston State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Memorial Hermann Texas Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sam Houston State 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>
      This project seeks to further study the effects of a hospital-based protocol for improving&#xD;
      sleep in high-risk antepartum patients as piloted by Lee and Gay (2017).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2022</start_date>
  <completion_date type="Actual">January 31, 2023</completion_date>
  <primary_completion_date type="Actual">July 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients who use the sleep improvement intervention</measure>
    <time_frame>Day 7</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of satisfaction with the intervention as assessed by a Likert assessment</measure>
    <time_frame>Day 7</time_frame>
    <description>The scale ranges from 0-5 with 5 being extremely satisfied</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Sleep Disturbance in Hospitalized Antepartum Patients</condition>
  <arm_group>
    <arm_group_label>Sleep Improvement Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care (Control)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients</intervention_name>
    <description>Patients are getting sleep hygiene education and a sleep hygiene kit.</description>
    <arm_group_label>Sleep Improvement Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  speak, read, and write English&#xD;
&#xD;
          -  medically stable&#xD;
&#xD;
          -  20 weeks' gestation or greater&#xD;
&#xD;
          -  viable fetus&#xD;
&#xD;
          -  hospitalized at least 24 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not speak, read, and write English&#xD;
&#xD;
          -  Medically unstable&#xD;
&#xD;
          -  Less than 20 weeks' gestation&#xD;
&#xD;
          -  Nonviable fetus&#xD;
&#xD;
          -  Hospitalized less than 24 hours&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea M Smith, Ph.D., RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sam Houston State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Hermann Texas Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sam Houston State University</investigator_affiliation>
    <investigator_full_name>Andrea Smith</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</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/NCT04485728
org study id: IRB-2020-83
nct id: NCT04485728
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project seeks to further study the effects of a hospital-based protocol for improving
      sleep in high-risk antepartum patients as piloted by Lee and Gay (2017).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients who use the sleep improvement intervention
time frame: Day 7
measure: Level of satisfaction with the intervention as assessed by a Likert assessment
time frame: Day 7
description: The scale ranges from 0-5 with 5 being extremely satisfied
arm group label: Sleep Improvement Intervention
arm group type: Experimental
arm group label: Standard of Care (Control)
arm group type: No Intervention
intervention type: Behavioral
intervention name: Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients
description: Patients are getting sleep hygiene education and a sleep hygiene kit.
arm group label: Sleep Improvement Intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andrea M Smith, Ph.D., RN
role: Principal Investigator
affiliation: Sam Houston State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Sam Houston State University
investigator full name: Andrea Smith
investigator title: Assistant Professor
mesh term: Dyssomnias
mesh term: Parasomnias
sharing ipd: No