<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/NCT03301727</url>
  </required_header>
  <id_info>
    <org_study_id>REB15-2137</org_study_id>
    <nct_id>NCT03301727</nct_id>
  </id_info>
  <brief_title>Sleeping for Two: RCT of CBT-Insomnia in Pregnancy</brief_title>
  <official_title>A Pilot Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</source>
  <brief_summary>
    <textblock>
      Cognitive-behavioural therapy for insomnia (CBT-I) has been shown to be an effective&#xD;
      treatment for insomnia in multiple populations, including women during pregnancy and&#xD;
      postpartum. Online CBT-I has also been shown to be effective and comparable to in-person&#xD;
      CBT-I, and shows promise as an accessible treatment alternative to in-person CBT-I for&#xD;
      pregnant women experiencing insomnia. As the harmful consequences of insomnia or sleep&#xD;
      disturbances have been well documented during late pregnancy, this randomized-controlled&#xD;
      trial will compare the efficacy of both in-person and online CBT-I on pregnant women with&#xD;
      insomnia to a wait-list control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of the current project is to evaluate the impact of a 6-week in-person CBT-I,&#xD;
      versus online CBT-I, versus a wait-list in reducing symptoms of insomnia (assessed&#xD;
      subjectively by self-report and objectively with actigraphy) experienced in pregnancy. The&#xD;
      investigators hypothesize that participants who receive a 6-week program of either in-person&#xD;
      CBT-I or online CBT-I (versus a wait-list) will report fewer insomnia symptoms and have&#xD;
      improved objectively assessed sleep measured at one-week post-treatment. Based on previous&#xD;
      research findings, the investigators do not expect that there will be a difference between&#xD;
      in-person CBT-I and online CBT-I administration.&#xD;
&#xD;
      The secondary aim is to investigate if CBT-I versus a wait-list will reduce symptoms of&#xD;
      depression at one-week post-treatment. The investigators hypothesize that participants who&#xD;
      receive in-person CBT-I and online CBT-I (versus a wait-list) will report fewer depressive&#xD;
      symptoms measured at one-week post-treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">March 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Insomnia Severity Index</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>The ISI is a 7-item questionnaire designed to identify cases of insomnia and evaluate treatment outcomes. The ISI assesses severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and perceived distress caused by sleep problems. It was found to be a clinically useful tool in assessing changes in insomnia symptoms in insomnia treatment research.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in the Pittsburgh Sleep Quality Index</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>The PSQI instrument is used in assessing one's sleep quality during the previous month. It consists of 19 self-rated items and 5 questions rated by the roommate or bed partner. There are seven components of the PSQI and these are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Actigraphy (Actiwatch II, Phillips, USA)</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>Actigraphy monitoring provides objective sleep, combining measurements of: circadian rhythm amplitude, acrophase, mesor, sleep efficiency, sleep latency, total sleep time, and number and frequency of awakenings.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Sleep Logs</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Edinburgh Postpartum Depression Scale</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>Symptoms of depression in pregnancy and the postpartum will be assessed by the EPDS. The EPDS consists of 10 items and is a reliable and valid tool for identifying symptoms of depression experienced in pregnancy and the postpartum.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in the Multidimensional Fatigue Symptom Inventory - Short Form</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>30-item short form version of MFSI was designed to assess manifestations of fatigue.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the Dysfunctional Beliefs and Attitudes about Sleep Questionnaire</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>Cognitive scale of 16 items used for assessing problematic levels of unhelpful beliefs about sleep.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the Sleep Self-Efficacy Scale</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>9-item scale used for measuring one's level of confidence in carrying out specific sleep-related behaviors.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the Sleep Hygiene Index</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>13-item self-report items used for assessing presence of behaviors thought to compromise sleep hygiene.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the Pre-Sleep Arousal Scale</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>16-item self-report measure assessing pre-sleep arousal.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the Glasgow Sleep Effort Scale</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>Measure of sleep-related effort.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the Sleep-Related Behaviors Questionnaire</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>Designed to assess use of safety behaviours to promote sleep and cope with tiredness.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the Epworth Sleepiness Scale</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>8-item scale designed to assess the tendency to fall asleep in situations</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the Generalized Anxiety Disorder index</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>Brief measure for assessing symptoms of generalized anxiety disorder.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the Couple Satisfaction Index</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>16-item scale assessing participants' relationship satisfaction.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the Big Five Inventory</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>44-items assessing personality.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the Extended Brief Infant Sleep Questionnaire</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>24-items assessing infant sleep.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the Pregnancy-Specific Anxiety Measure</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>4-items assessing anxiety during pregnancy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the PROMIS Adult Version 1.0 Pain Interference Short Form 8a</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>8-items assessing interference of pain in functioning.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in the PROMIS Adult Version 1.0 Pain Intensity Short Form 3a</measure>
    <time_frame>Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up</time_frame>
    <description>3-items assessing intensity of pain symptoms.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Insomnia</condition>
  <condition>Sleep Disturbance</condition>
  <arm_group>
    <arm_group_label>In-person CBT-I Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive 6 in-person weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Online CBT-I Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive 6 online weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants are placed on a wait-list for 6 weeks before receiving either in-person or online 6 weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive-Behavioural Therapy for Insomnia (CBT-I)</intervention_name>
    <description>Cognitive-Behavioural Therapy for Insomnia (CBT-I) is an evidence-based psycho-therapeutic intervention, combining cognitive and behavioural principles to provide psycho-education concerning contributing thoughts to sleep problem maintenance, and behavioural technique instruction to reduce sleep onset latency and promote effective sleep maintenance.</description>
    <arm_group_label>In-person CBT-I Treatment</arm_group_label>
    <arm_group_label>Online CBT-I Treatment</arm_group_label>
    <arm_group_label>Wait-list Control</arm_group_label>
    <other_name>Cognitive-Behavioral Therapy for Insomnia (CBT-I)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 years or greater&#xD;
&#xD;
          -  Gestation: 12 - 30 weeks&#xD;
&#xD;
          -  Identifying as experiencing sleep disturbances&#xD;
&#xD;
          -  Language: English-intermediate or above&#xD;
&#xD;
          -  Have access to internet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Experiencing symptoms of sleep disorders other than insomnia&#xD;
&#xD;
          -  Currently taking prescribed medications for sleep problems&#xD;
&#xD;
          -  History of untreated, serious psychiatric illness&#xD;
&#xD;
          -  Substance-use during pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lianne Tomfohr-Madsen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 1N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3T 2N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>September 13, 2018</last_update_submitted>
  <last_update_submitted_qc>September 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
    <mesh_term>Dyssomnias</mesh_term>
    <mesh_term>Parasomnias</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03301727/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03301727
org study id: REB15-2137
nct id: NCT03301727
lead sponsor: 
collaborator: 
Cognitive-behavioural therapy for insomnia (CBT-I) has been shown to be an effective
      treatment for insomnia in multiple populations, including women during pregnancy and
      postpartum. Online CBT-I has also been shown to be effective and comparable to in-person
      CBT-I, and shows promise as an accessible treatment alternative to in-person CBT-I for
      pregnant women experiencing insomnia. As the harmful consequences of insomnia or sleep
      disturbances have been well documented during late pregnancy, this randomized-controlled
      trial will compare the efficacy of both in-person and online CBT-I on pregnant women with
      insomnia to a wait-list control group.
The primary aim of the current project is to evaluate the impact of a 6-week in-person CBT-I,
      versus online CBT-I, versus a wait-list in reducing symptoms of insomnia (assessed
      subjectively by self-report and objectively with actigraphy) experienced in pregnancy. The
      investigators hypothesize that participants who receive a 6-week program of either in-person
      CBT-I or online CBT-I (versus a wait-list) will report fewer insomnia symptoms and have
      improved objectively assessed sleep measured at one-week post-treatment. Based on previous
      research findings, the investigators do not expect that there will be a difference between
      in-person CBT-I and online CBT-I administration.

      The secondary aim is to investigate if CBT-I versus a wait-list will reduce symptoms of
      depression at one-week post-treatment. The investigators hypothesize that participants who
      receive in-person CBT-I and online CBT-I (versus a wait-list) will report fewer depressive
      symptoms measured at one-week post-treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in the Insomnia Severity Index
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: The ISI is a 7-item questionnaire designed to identify cases of insomnia and evaluate treatment outcomes. The ISI assesses severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and perceived distress caused by sleep problems. It was found to be a clinically useful tool in assessing changes in insomnia symptoms in insomnia treatment research.
measure: Change in the Pittsburgh Sleep Quality Index
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: The PSQI instrument is used in assessing one's sleep quality during the previous month. It consists of 19 self-rated items and 5 questions rated by the roommate or bed partner. There are seven components of the PSQI and these are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction.
measure: Change in Actigraphy (Actiwatch II, Phillips, USA)
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: Actigraphy monitoring provides objective sleep, combining measurements of: circadian rhythm amplitude, acrophase, mesor, sleep efficiency, sleep latency, total sleep time, and number and frequency of awakenings.
measure: Change in Sleep Logs
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings.
measure: Change in the Edinburgh Postpartum Depression Scale
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: Symptoms of depression in pregnancy and the postpartum will be assessed by the EPDS. The EPDS consists of 10 items and is a reliable and valid tool for identifying symptoms of depression experienced in pregnancy and the postpartum.
measure: Change in the Multidimensional Fatigue Symptom Inventory - Short Form
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: 30-item short form version of MFSI was designed to assess manifestations of fatigue.
measure: Change in the Dysfunctional Beliefs and Attitudes about Sleep Questionnaire
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: Cognitive scale of 16 items used for assessing problematic levels of unhelpful beliefs about sleep.
measure: Change in the Sleep Self-Efficacy Scale
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: 9-item scale used for measuring one's level of confidence in carrying out specific sleep-related behaviors.
measure: Change in the Sleep Hygiene Index
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: 13-item self-report items used for assessing presence of behaviors thought to compromise sleep hygiene.
measure: Change in the Pre-Sleep Arousal Scale
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: 16-item self-report measure assessing pre-sleep arousal.
measure: Change in the Glasgow Sleep Effort Scale
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: Measure of sleep-related effort.
measure: Change in the Sleep-Related Behaviors Questionnaire
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: Designed to assess use of safety behaviours to promote sleep and cope with tiredness.
measure: Change in the Epworth Sleepiness Scale
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: 8-item scale designed to assess the tendency to fall asleep in situations
measure: Change in the Generalized Anxiety Disorder index
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: Brief measure for assessing symptoms of generalized anxiety disorder.
measure: Change in the Couple Satisfaction Index
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: 16-item scale assessing participants' relationship satisfaction.
measure: Change in the Big Five Inventory
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: 44-items assessing personality.
measure: Change in the Extended Brief Infant Sleep Questionnaire
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: 24-items assessing infant sleep.
measure: Change in the Pregnancy-Specific Anxiety Measure
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: 4-items assessing anxiety during pregnancy.
measure: Change in the PROMIS Adult Version 1.0 Pain Interference Short Form 8a
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: 8-items assessing interference of pain in functioning.
measure: Change in the PROMIS Adult Version 1.0 Pain Intensity Short Form 3a
time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
description: 3-items assessing intensity of pain symptoms.
arm group label: In-person CBT-I Treatment
arm group type: Active Comparator
description: Participants receive 6 in-person weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.
arm group label: Online CBT-I Treatment
arm group type: Active Comparator
description: Participants receive 6 online weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.
arm group label: Wait-list Control
arm group type: Other
description: Participants are placed on a wait-list for 6 weeks before receiving either in-person or online 6 weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.
intervention type: Other
intervention name: Cognitive-Behavioural Therapy for Insomnia (CBT-I)
description: Cognitive-Behavioural Therapy for Insomnia (CBT-I) is an evidence-based psycho-therapeutic intervention, combining cognitive and behavioural principles to provide psycho-education concerning contributing thoughts to sleep problem maintenance, and behavioural technique instruction to reduce sleep onset latency and promote effective sleep maintenance.
arm group label: In-person CBT-I Treatment
arm group label: Online CBT-I Treatment
arm group label: Wait-list Control
other name: Cognitive-Behavioral Therapy for Insomnia (CBT-I)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lianne Tomfohr-Madsen, PhD
role: Principal Investigator
affiliation: University of Calgary
facility: 
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Sleep Initiation and Maintenance Disorders
mesh term: Dyssomnias
mesh term: Parasomnias
provided document: 