<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/NCT03763071</url>
  </required_header>
  <id_info>
    <org_study_id>2018-1</org_study_id>
    <nct_id>NCT03763071</nct_id>
  </id_info>
  <brief_title>Sleep Disturbances in the 2nd and 3rd Trimester</brief_title>
  <official_title>Sleep Patterns and Disturbances in the Second and Third Trimester of Uncomplicated Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bartin State Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bartin State Hospital</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 disorders and disturbances are mostly underestimated in clinical practice. Moreover,&#xD;
      this problem is generally neglected by the pregnant themselves. Today, it is important to&#xD;
      underline any problem that may have an affect to improve the quality of life during&#xD;
      pregnancy.&#xD;
&#xD;
      This study assesses the sleep quality, insomnia patterns and obstructive sleep apnea in the&#xD;
      second and third trimesters of pregnancy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women with uncomplicated pregnancy in the second or third trimester who apply for the routine&#xD;
      check will be included.&#xD;
&#xD;
      Specific questionnaires will be used to measure the sleep disorders in addition to the&#xD;
      socio-demographic measures:&#xD;
&#xD;
      Pittsburgh Sleep Quality Index, Insomnia Severity Index, Berlin Questionnaire and Stop-Bang&#xD;
      Questionnaire.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Actual">April 29, 2020</completion_date>
  <primary_completion_date type="Actual">April 8, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>Through study completion, an average of 39 weeks</time_frame>
    <description>The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score) on a single page. Item 10, which is the second page of the scale, does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Berlin Questionnaire</measure>
    <time_frame>Through study completion, an average of 39 weeks</time_frame>
    <description>The questionnaire consists of 3 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stop-Bang questionnaire</measure>
    <time_frame>Through study completion, an average of 39 weeks</time_frame>
    <description>This questionnaire evaluates the risk of sleep apnea. Low risk of OSA: Yes to 0-2 questions Intermediate risk of OSA: Yes to 3-4 questions High risk of OSA: Yes to 5-8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI &gt; 35 kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>Through study completion, an average of 39 weeks</time_frame>
    <description>ISI measures the insomnia and related parameters. Scoring and Interpretation as follows: Add the scores for all seven items (questions 1 + 2 + 3 + 4 + 5 +6 + 7) will give the total score. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">683</enrollment>
  <condition>Sleep Initiation and Maintenance Disorders</condition>
  <condition>Sleep</condition>
  <condition>Sleep Apnea</condition>
  <condition>Sleep Disorder</condition>
  <condition>Sleep Disturbance</condition>
  <condition>Sleep Apnea, Obstructive</condition>
  <condition>Pregnancy Related</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>Participants</arm_group_label>
    <description>Pregnant women in the 2nd or 3th trimester Patient-reported scales to measure sleep disorders</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient-reported scales to measure sleep disorders</intervention_name>
    <description>Patient-reported scales to measure sleep disorders include below mentioned scales:&#xD;
Pittsburgh Sleep Quality Index; measures the quality of sleep Berlin Questionnaire; measures the obstructive sleep apnea Stop-Bang questionnaire; measures the obstructive sleep apnea Insomnia Severity Index; measures the insomnia and related parameters</description>
    <arm_group_label>Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Volunteered, low-risk, uncomplicated singleton pregnancy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  2nd or 3rd trimester of pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Complicated pregnancy&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Known sleep disorder&#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>Murat Yassa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bartin State Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bartin State Hospital</name>
      <address>
        <city>Bartin</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 1, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>January 24, 2021</last_update_submitted>
  <last_update_submitted_qc>January 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bartin State Hospital</investigator_affiliation>
    <investigator_full_name>Murat Yassa</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03763071
org study id: 2018-1
nct id: NCT03763071
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sleep disorders and disturbances are mostly underestimated in clinical practice. Moreover,
      this problem is generally neglected by the pregnant themselves. Today, it is important to
      underline any problem that may have an affect to improve the quality of life during
      pregnancy.

      This study assesses the sleep quality, insomnia patterns and obstructive sleep apnea in the
      second and third trimesters of pregnancy.
Women with uncomplicated pregnancy in the second or third trimester who apply for the routine
      check will be included.

      Specific questionnaires will be used to measure the sleep disorders in addition to the
      socio-demographic measures:

      Pittsburgh Sleep Quality Index, Insomnia Severity Index, Berlin Questionnaire and Stop-Bang
      Questionnaire.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Pittsburgh Sleep Quality Index (PSQI)
time frame: Through study completion, an average of 39 weeks
description: The order of the PSQI items has been modified from the original order in order to fit the first 9 items (which are the only items that contribute to the total score) on a single page. Item 10, which is the second page of the scale, does not contribute to the PSQI score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
measure: Berlin Questionnaire
time frame: Through study completion, an average of 39 weeks
description: The questionnaire consists of 3 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive.
measure: Stop-Bang questionnaire
time frame: Through study completion, an average of 39 weeks
description: This questionnaire evaluates the risk of sleep apnea. Low risk of OSA: Yes to 0-2 questions Intermediate risk of OSA: Yes to 3-4 questions High risk of OSA: Yes to 5-8 questions or Yes to 2 or more of 4 STOP questions + male gender or Yes to 2 or more of 4 STOP questions + BMI > 35 kg/m2 or Yes to 2 or more of 4 STOP questions + neck circumference.
measure: Insomnia Severity Index (ISI)
time frame: Through study completion, an average of 39 weeks
description: ISI measures the insomnia and related parameters. Scoring and Interpretation as follows: Add the scores for all seven items (questions 1 + 2 + 3 + 4 + 5 +6 + 7) will give the total score. Total score categories: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
arm group label: Participants
description: Pregnant women in the 2nd or 3th trimester Patient-reported scales to measure sleep disorders
intervention type: Other
intervention name: Patient-reported scales to measure sleep disorders
description: Patient-reported scales to measure sleep disorders include below mentioned scales:
Pittsburgh Sleep Quality Index; measures the quality of sleep Berlin Questionnaire; measures the obstructive sleep apnea Stop-Bang questionnaire; measures the obstructive sleep apnea Insomnia Severity Index; measures the insomnia and related parameters
arm group label: Participants
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Murat Yassa, MD
role: Principal Investigator
affiliation: Bartin State Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Bartin State Hospital
investigator full name: Murat Yassa
investigator title: M.D.
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Sleep Wake Disorders
mesh term: Parasomnias
mesh term: Dyssomnias
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: Undecided