<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/NCT04487483</url>
  </required_header>
  <id_info>
    <org_study_id>SleepAppEvaluation</org_study_id>
    <nct_id>NCT04487483</nct_id>
  </id_info>
  <brief_title>Exploring the Impact of a Sleep App on Sleep Quality</brief_title>
  <official_title>Exploring the Impact of a Sleep App on Sleep Quality: a Randomised Controlled Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College, London</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>
      Sufficient sleep is crucial for good health, yet a third of UK adults have impaired sleep&#xD;
      quality. Therefore, there is urgent need for population-level sleep interventions. However,&#xD;
      many sleep interventions (such as Cognitive Behavioural Therapy for Insomnia) are resource&#xD;
      intensive and not widely available. Research demonstrates that smartphone interventions are&#xD;
      an effective way to reach the wider population. However, many commercially available&#xD;
      smartphone sleep applications focus on one technique, and hence do not tailor to the diverse&#xD;
      needs of individuals. A new sleep app offers six different techniques, allowing individuals&#xD;
      to shape their own journey to improved sleep quality. The investigators aim to test the sleep&#xD;
      app's efficacy and gather user experience data to allow app optimisation. The study is a&#xD;
      two-arm pilot randomised control trial (RCT). After recruitment and screening, baseline&#xD;
      measurements will be taken: subjective sleep quality data will be collected using the&#xD;
      Insomnia Severity Index (ISI) and the Consensus Sleep Diary from all participants and&#xD;
      objective accelerometry data via an Oura Ring (worn on finger for a week) on a subsample of&#xD;
      participants. Participants will then be randomised to the intervention or control.&#xD;
      Intervention participants will be given free use of the sleep app for 3 months. Controls will&#xD;
      be informed that they will not receive access to the intervention and will be asked to&#xD;
      abstain from using any other digital sleep-based intervention during the 3 months. All&#xD;
      participants will be given the ISI after each month and will be given the Consensus Sleep&#xD;
      Diary to fill out for one week again after 2 months. The planned Oura ring follow-up after 2&#xD;
      months for participants who wore the Oura ring at baseline has been cancelled due to&#xD;
      COVID-19. User engagement will be assessed using the Digital Behaviour Change Intervention&#xD;
      Engagement Scale. Telephone interviews will also be conducted with 20-30 participants to&#xD;
      explore experience of using the app, how the comparison group felt about being allocated to&#xD;
      the control group and how the COVID-19 pandemic may have affected their sleep and other&#xD;
      measures of the study. Change in self-reported sleep will be the primary outcome and&#xD;
      qualitative user data secondary. Appropriate tests (such as an ANOVA or linear regression&#xD;
      controlling for baseline sleep and testing for effect of group when using continuous data)&#xD;
      and thematic analysis of qualitative interview data will be conducted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">February 13, 2020</start_date>
  <completion_date type="Anticipated">August 15, 2020</completion_date>
  <primary_completion_date type="Actual">June 17, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>The study is a two-arm pilot RCT where participants are randomly assigned to either the intervention or control group.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in self-reported sleep quality</measure>
    <time_frame>Baseline/1 month/2 months/3 months</time_frame>
    <description>Measured using the Insomnia Severity Index. The scores from the Insomnia Severity Index range from 0 to 28, where higher scores indicate worse sleep quality.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in self-reported sleep</measure>
    <time_frame>Baseline/2 months</time_frame>
    <description>Measured using the Consensus Sleep Diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Engagement with the sleep app</measure>
    <time_frame>Once a week for 3 months</time_frame>
    <description>Participant's responses to the Digital Behaviour Change Intervention Engagement Scale (only applicable to participants in the intervention group). The scores from the Digital Behaviour Change Intervention Engagement Scale range from 8 to 56, where higher scores indicate higher engagement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Telephone interview qualitative user data</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Participant's qualitative responses to telephone interview questions about their experience of using the sleep app, how the comparison group felt about being allocated to the control group, and how the COVID-19 pandemic may have affected their sleep and other measures of the study (on a subsample of 20-30 participants).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Sleep App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this condition will receive full free access to the &quot;Pro&quot; version of the sleep app and asked to use the app every day for three months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this condition will be asked to continue their life as normal and abstain from downloading or using any sleep aid and/or sleep tracker app for three months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleep App</intervention_name>
    <description>A sleep app offering 6 evidence based techniques to improve sleep (such as Cognitive Behavioural Therapy for Insomnia, Progressive Muscle Relaxation and Mindfulness Meditation), allowing for a personally tailored journey of sleep aids within the app.</description>
    <arm_group_label>Sleep App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 or above&#xD;
&#xD;
          -  Own a smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a clinically diagnosed sleep disorder for which they are currently being&#xD;
             treated&#xD;
&#xD;
          -  Frequent use (once a week or more) of any sleep medication&#xD;
&#xD;
          -  Enrolment on another sleep trial&#xD;
&#xD;
          -  Being unwilling to cease usage of other sleep apps for the duration of the study&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Abi Fisher</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College, London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University College London</name>
      <address>
        <city>London</city>
        <zip>WC1E 7HB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University College, London</investigator_affiliation>
    <investigator_full_name>Abi Fisher</investigator_full_name>
    <investigator_title>Associate Professor of Physical Activity and Health</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pilot study and the investigators plan to disseminate findings in a peer reviewed publication and a masters thesis.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 7, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/83/NCT04487483/SAP_001.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/NCT04487483
org study id: SleepAppEvaluation
nct id: NCT04487483
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sufficient sleep is crucial for good health, yet a third of UK adults have impaired sleep
      quality. Therefore, there is urgent need for population-level sleep interventions. However,
      many sleep interventions (such as Cognitive Behavioural Therapy for Insomnia) are resource
      intensive and not widely available. Research demonstrates that smartphone interventions are
      an effective way to reach the wider population. However, many commercially available
      smartphone sleep applications focus on one technique, and hence do not tailor to the diverse
      needs of individuals. A new sleep app offers six different techniques, allowing individuals
      to shape their own journey to improved sleep quality. The investigators aim to test the sleep
      app's efficacy and gather user experience data to allow app optimisation. The study is a
      two-arm pilot randomised control trial (RCT). After recruitment and screening, baseline
      measurements will be taken: subjective sleep quality data will be collected using the
      Insomnia Severity Index (ISI) and the Consensus Sleep Diary from all participants and
      objective accelerometry data via an Oura Ring (worn on finger for a week) on a subsample of
      participants. Participants will then be randomised to the intervention or control.
      Intervention participants will be given free use of the sleep app for 3 months. Controls will
      be informed that they will not receive access to the intervention and will be asked to
      abstain from using any other digital sleep-based intervention during the 3 months. All
      participants will be given the ISI after each month and will be given the Consensus Sleep
      Diary to fill out for one week again after 2 months. The planned Oura ring follow-up after 2
      months for participants who wore the Oura ring at baseline has been cancelled due to
      COVID-19. User engagement will be assessed using the Digital Behaviour Change Intervention
      Engagement Scale. Telephone interviews will also be conducted with 20-30 participants to
      explore experience of using the app, how the comparison group felt about being allocated to
      the control group and how the COVID-19 pandemic may have affected their sleep and other
      measures of the study. Change in self-reported sleep will be the primary outcome and
      qualitative user data secondary. Appropriate tests (such as an ANOVA or linear regression
      controlling for baseline sleep and testing for effect of group when using continuous data)
      and thematic analysis of qualitative interview data will be conducted.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study is a two-arm pilot RCT where participants are randomly assigned to either the intervention or control group.
primary purpose: Other
masking: None (Open Label)
measure: Change in self-reported sleep quality
time frame: Baseline/1 month/2 months/3 months
description: Measured using the Insomnia Severity Index. The scores from the Insomnia Severity Index range from 0 to 28, where higher scores indicate worse sleep quality.
measure: Change in self-reported sleep
time frame: Baseline/2 months
description: Measured using the Consensus Sleep Diary.
measure: Engagement with the sleep app
time frame: Once a week for 3 months
description: Participant's responses to the Digital Behaviour Change Intervention Engagement Scale (only applicable to participants in the intervention group). The scores from the Digital Behaviour Change Intervention Engagement Scale range from 8 to 56, where higher scores indicate higher engagement.
measure: Telephone interview qualitative user data
time frame: Up to 6 months
description: Participant's qualitative responses to telephone interview questions about their experience of using the sleep app, how the comparison group felt about being allocated to the control group, and how the COVID-19 pandemic may have affected their sleep and other measures of the study (on a subsample of 20-30 participants).
arm group label: Sleep App
arm group type: Experimental
description: Participants in this condition will receive full free access to the "Pro" version of the sleep app and asked to use the app every day for three months.
arm group label: Control
arm group type: No Intervention
description: Participants in this condition will be asked to continue their life as normal and abstain from downloading or using any sleep aid and/or sleep tracker app for three months.
intervention type: Behavioral
intervention name: Sleep App
description: A sleep app offering 6 evidence based techniques to improve sleep (such as Cognitive Behavioural Therapy for Insomnia, Progressive Muscle Relaxation and Mindfulness Meditation), allowing for a personally tailored journey of sleep aids within the app.
arm group label: Sleep App
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Abi Fisher
role: Principal Investigator
affiliation: University College, London
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University College, London
investigator full name: Abi Fisher
investigator title: Associate Professor of Physical Activity and Health
sharing ipd: No
ipd description: Pilot study and the investigators plan to disseminate findings in a peer reviewed publication and a masters thesis.
provided document: 