<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/NCT04406103</url>
  </required_header>
  <id_info>
    <org_study_id>2020-5184</org_study_id>
    <nct_id>NCT04406103</nct_id>
  </id_info>
  <brief_title>Protocol - Your Answers When Needing Sleep in New Brunswick</brief_title>
  <acronym>YAWNS NB</acronym>
  <official_title>Your Answers When Needing Sleep in New Brunswick (YAWNS NB): A Randomized Controlled Trial Comparing Sleepwell, EMPOWER, and Treatment as Usual for Benzodiazepine Receptor Agonist Discontinuation in Older Adults (Protocol)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>David Gardner</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of New Brunswick</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dalhousie University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dalhousie 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>
      New Brunswick has an aging population with Canada's highest rate of sleeping pill use. The&#xD;
      rate of long-term (chronic) use among NB seniors is 25%, well in excess of the Canadian&#xD;
      average of 10%. The rate of use is higher in women and increases with age, as do risks for&#xD;
      serious harms.&#xD;
&#xD;
      Sleeping pills risks are substantial and costly, especially to seniors. Research does not&#xD;
      support their long-term use. Risk for falls causing injuries, including hip fractures, is a&#xD;
      leading concern. They impair mental and physical functioning resulting in a loss of&#xD;
      independence and cause impaired driving and a higher rate of serious crashes. The rate of&#xD;
      near-fatal and fatal overdoses from mixing sleeping pills with other drugs is on the rise.&#xD;
      Stopping treatment can be difficult due to physical dependence and withdrawal symptoms.&#xD;
&#xD;
      Cognitive behavioural therapy for insomnia (CBTi) is recommended as the first-line treatment&#xD;
      of chronic insomnia. Sleeping pills are only to be considered when CBTi fails. However, these&#xD;
      recommendations are not reflected in primary care practice.&#xD;
&#xD;
      Internationally, many educational interventions targeting prescribers have been tried, yet&#xD;
      have failed to reduce sleeping pill use. However, a 12-page pamphlet (EMPOWER) given directly&#xD;
      to seniors in a clinical trial was associated with a large reduction in sleeping pill use.&#xD;
      Using a similarly persuasive approach, Sleepwell (mysleepwell.ca) was developed to reduce the&#xD;
      use of sleeping pills and facilitate CBTi access and use. Sleepwell differs from EMPOWER by&#xD;
      providing specific information and recommendations regarding CBTi in addition to guidance on&#xD;
      how to stop sleeping pills.&#xD;
&#xD;
      This study will evaluate the effectiveness of direct-to-patient interventions on long-term&#xD;
      sleeping pill use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are proposing to investigate direct-to-patient health promotion&#xD;
      interventions that promote sleeping pill dose reduction and treatment discontinuation by&#xD;
      enhancing self-efficacy through various behaviour change techniques embedded in printed&#xD;
      information provided to patients. Seniors will be invited to participate via direct telephone&#xD;
      contact, information sharing through seniors' organizations, education sessions for seniors,&#xD;
      and public notices. Prospective participants will be given the option of which way they would&#xD;
      like to participate in the research:&#xD;
&#xD;
      Option 1: full participation including baseline interview, 6-month interview, and access to&#xD;
      specific data from the participant's personal health record); Option 2: limited participation&#xD;
      to baseline and 6-month interviews only; and Option 3: limited participation to baseline&#xD;
      interview and access to specific data from the participant's personal health record.&#xD;
&#xD;
      This will form two sets of participants; those who do and those who do not permit access to&#xD;
      outcomes from their personal health record. Participants that select Options 1 or 3 will&#xD;
      consent to their medication and health resources use being assessed objectively over a six&#xD;
      month period. Participants that choose Options 1 or 2 will directly provide baseline&#xD;
      information about their health, medication use, and use of health resources via&#xD;
      communications with researchers. Similar information will be collected directly from&#xD;
      participants in this group after six months.&#xD;
&#xD;
      Random group allocation:&#xD;
&#xD;
      Options 1 and 2: i) Sleepwell package; ii) Empower package; iii) No package Option 3: i)&#xD;
      Sleepwell package; ii) No package&#xD;
&#xD;
      The investigators will compare the rates of reducing and stopping sleeping pill use among the&#xD;
      different groups over 6 months. Safety outcomes including falls and hospital visits will be&#xD;
      measured. The investigators will also track participant access to online CBTi resources using&#xD;
      Google Analytics.&#xD;
&#xD;
      Encouraging results from this study of direct-to-patient health promotion regarding insomnia&#xD;
      management and sleeping pill use can be utilized repeatedly over time to reach all&#xD;
      individuals who could benefit from the intervention, leading a transformational change in&#xD;
      insomnia management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2020</start_date>
  <completion_date type="Actual">March 30, 2023</completion_date>
  <primary_completion_date type="Actual">October 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>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 participants discontinuing BZRA treatment within 6 months</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants discontinuing BZRA treatment within 3 months</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with BZRA dose change of 25% or more within 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>Relative change in BZRA dose between baseline and 6 months is 25% or greater.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants starting a new non-BZRA sedative-hypnotic</measure>
    <time_frame>6 months</time_frame>
    <description>Newly started on other sedative-hypnotics</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Score on the Beliefs about Medicines Questionnaire (BMQ)</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>BMQ</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of visits to mysleepwell.ca website</measure>
    <time_frame>6 months</time_frame>
    <description>The count of website visits by study participants in the Sleepwell arm during 6 months</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to fall asleep (minutes)</measure>
    <time_frame>baseline, 6 mo.</time_frame>
    <description>Sleep onset latency (SOL) measured in minutes</description>
  </other_outcome>
  <other_outcome>
    <measure>Time spent asleep (minutes)</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>Total sleep time (TST) measured in minutes</description>
  </other_outcome>
  <other_outcome>
    <measure>Sleep efficiency (%)</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>Time spent sleeping (min.) compared to total time spent in bed (min) x 100</description>
  </other_outcome>
  <other_outcome>
    <measure>Score on the Epworth Sleepiness Scale</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>Assessment of daytime sleepiness</description>
  </other_outcome>
  <other_outcome>
    <measure>Score on the Insomnia Severity Index</measure>
    <time_frame>baseline, 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Score on the Generalized anxiety disorder - 7</measure>
    <time_frame>baseline, 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Vulnerable elderly survey, 13-item version</measure>
    <time_frame>baseline, 6 months</time_frame>
    <description>A function-based self-reported brief survey to assess risk of functional decline and death</description>
  </other_outcome>
  <other_outcome>
    <measure>Score on the Quality of life SF-12v2</measure>
    <time_frame>baseline, 6 mo.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants reporting having a fall (subjective)</measure>
    <time_frame>baseline, 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants reporting having a fall-related health visit</measure>
    <time_frame>baseline, 6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Responses to the prescriber acceptability survey</measure>
    <time_frame>6 months</time_frame>
    <description>Prescribers will be invited to respond to this end-of-study survey assessing their acceptability of the Sleepwell intervention. The development of this survey was informed by the Theoretical Framework of Acceptability</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">594</enrollment>
  <condition>Insomnia Chronic</condition>
  <arm_group>
    <arm_group_label>Sleepwell</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mailed information package includes 2 Sleepwell booklets (How to get your sleep back and How to stop sleeping pills)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Empower</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mailed information package includes 2 Empower booklets (You may be at risk AND How to get a good night's sleep without sleeping pills)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment-as-usual group: no mailed intervention package.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sleepwell</intervention_name>
    <description>Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.</description>
    <arm_group_label>Sleepwell</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Empower</intervention_name>
    <description>Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.</description>
    <arm_group_label>Empower</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  residents of New Brunswick, Canada&#xD;
&#xD;
          -  age 65 or older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  community dwelling with no anticipated change of address for the next 6 months&#xD;
&#xD;
          -  current user of BZRAs (3 or more bedtime doses in previous 7 days)&#xD;
&#xD;
          -  long-term user of BZRA: use 3 months or longer&#xD;
&#xD;
          -  BZRA indication: insomnia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  using non-BZRA sedative-hypnotics for treating insomnia or related sleep problems&#xD;
             (e.g., trazodone, quetiapine, tricyclic antidepressant, mirtazapine, melatonin,&#xD;
             diphenhydramine, dimenhyrdinate)&#xD;
&#xD;
          -  use of alcohol or cannabis 3 or more nights a week for sleep problems&#xD;
&#xD;
          -  diagnosis of other sleep disorders: sleep terrors, sleep apnea, restless legs&#xD;
             syndrome, narcolepsy, sleepwalking&#xD;
&#xD;
          -  severe anxiety disorder&#xD;
&#xD;
          -  obsessive compulsive disorder&#xD;
&#xD;
          -  severe cognitive impairment&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  seizure disorder&#xD;
&#xD;
          -  spinal injury&#xD;
&#xD;
          -  chronic psychotic disorder (e.g., schizophrenia)&#xD;
&#xD;
          -  bipolar disorder&#xD;
&#xD;
          -  cancer&#xD;
&#xD;
          -  receiving palliative care&#xD;
&#xD;
          -  living in a Long Term Care facility&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David M Gardner, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dalhousie University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of New Brunswick</name>
      <address>
        <city>Fredericton</city>
        <state>Nova Scotia</state>
        <zip>E3B 5A3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Dalhousie University</investigator_affiliation>
    <investigator_full_name>David Gardner</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>insomnia</keyword>
  <keyword>benzodiazepines</keyword>
  <keyword>deprescribing</keyword>
  <keyword>cognitive-behavioural therapy for insomnia (CBTi)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</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/NCT04406103
org study id: 2020-5184
nct id: NCT04406103
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
New Brunswick has an aging population with Canada's highest rate of sleeping pill use. The
      rate of long-term (chronic) use among NB seniors is 25%, well in excess of the Canadian
      average of 10%. The rate of use is higher in women and increases with age, as do risks for
      serious harms.

      Sleeping pills risks are substantial and costly, especially to seniors. Research does not
      support their long-term use. Risk for falls causing injuries, including hip fractures, is a
      leading concern. They impair mental and physical functioning resulting in a loss of
      independence and cause impaired driving and a higher rate of serious crashes. The rate of
      near-fatal and fatal overdoses from mixing sleeping pills with other drugs is on the rise.
      Stopping treatment can be difficult due to physical dependence and withdrawal symptoms.

      Cognitive behavioural therapy for insomnia (CBTi) is recommended as the first-line treatment
      of chronic insomnia. Sleeping pills are only to be considered when CBTi fails. However, these
      recommendations are not reflected in primary care practice.

      Internationally, many educational interventions targeting prescribers have been tried, yet
      have failed to reduce sleeping pill use. However, a 12-page pamphlet (EMPOWER) given directly
      to seniors in a clinical trial was associated with a large reduction in sleeping pill use.
      Using a similarly persuasive approach, Sleepwell (mysleepwell.ca) was developed to reduce the
      use of sleeping pills and facilitate CBTi access and use. Sleepwell differs from EMPOWER by
      providing specific information and recommendations regarding CBTi in addition to guidance on
      how to stop sleeping pills.

      This study will evaluate the effectiveness of direct-to-patient interventions on long-term
      sleeping pill use.
The investigators are proposing to investigate direct-to-patient health promotion
      interventions that promote sleeping pill dose reduction and treatment discontinuation by
      enhancing self-efficacy through various behaviour change techniques embedded in printed
      information provided to patients. Seniors will be invited to participate via direct telephone
      contact, information sharing through seniors' organizations, education sessions for seniors,
      and public notices. Prospective participants will be given the option of which way they would
      like to participate in the research:

      Option 1: full participation including baseline interview, 6-month interview, and access to
      specific data from the participant's personal health record); Option 2: limited participation
      to baseline and 6-month interviews only; and Option 3: limited participation to baseline
      interview and access to specific data from the participant's personal health record.

      This will form two sets of participants; those who do and those who do not permit access to
      outcomes from their personal health record. Participants that select Options 1 or 3 will
      consent to their medication and health resources use being assessed objectively over a six
      month period. Participants that choose Options 1 or 2 will directly provide baseline
      information about their health, medication use, and use of health resources via
      communications with researchers. Similar information will be collected directly from
      participants in this group after six months.

      Random group allocation:

      Options 1 and 2: i) Sleepwell package; ii) Empower package; iii) No package Option 3: i)
      Sleepwell package; ii) No package

      The investigators will compare the rates of reducing and stopping sleeping pill use among the
      different groups over 6 months. Safety outcomes including falls and hospital visits will be
      measured. The investigators will also track participant access to online CBTi resources using
      Google Analytics.

      Encouraging results from this study of direct-to-patient health promotion regarding insomnia
      management and sleeping pill use can be utilized repeatedly over time to reach all
      individuals who could benefit from the intervention, leading a transformational change in
      insomnia management.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants discontinuing BZRA treatment within 6 months
time frame: 6 months
measure: Number of participants discontinuing BZRA treatment within 3 months
time frame: 3 months
measure: Number of participants with BZRA dose change of 25% or more within 6 months
time frame: 6 months
description: Relative change in BZRA dose between baseline and 6 months is 25% or greater.
measure: Number of participants starting a new non-BZRA sedative-hypnotic
time frame: 6 months
description: Newly started on other sedative-hypnotics
measure: Score on the Beliefs about Medicines Questionnaire (BMQ)
time frame: baseline, 6 months
description: BMQ
measure: Number of visits to mysleepwell.ca website
time frame: 6 months
description: The count of website visits by study participants in the Sleepwell arm during 6 months
measure: Time to fall asleep (minutes)
time frame: baseline, 6 mo.
description: Sleep onset latency (SOL) measured in minutes
measure: Time spent asleep (minutes)
time frame: baseline, 6 months
description: Total sleep time (TST) measured in minutes
measure: Sleep efficiency (%)
time frame: baseline, 6 months
description: Time spent sleeping (min.) compared to total time spent in bed (min) x 100
measure: Score on the Epworth Sleepiness Scale
time frame: baseline, 6 months
description: Assessment of daytime sleepiness
measure: Score on the Insomnia Severity Index
time frame: baseline, 6 months
measure: Score on the Generalized anxiety disorder - 7
time frame: baseline, 6 months
measure: Vulnerable elderly survey, 13-item version
time frame: baseline, 6 months
description: A function-based self-reported brief survey to assess risk of functional decline and death
measure: Score on the Quality of life SF-12v2
time frame: baseline, 6 mo.
measure: Number of participants reporting having a fall (subjective)
time frame: baseline, 6 months
measure: Number of participants reporting having a fall-related health visit
time frame: baseline, 6 months
measure: Responses to the prescriber acceptability survey
time frame: 6 months
description: Prescribers will be invited to respond to this end-of-study survey assessing their acceptability of the Sleepwell intervention. The development of this survey was informed by the Theoretical Framework of Acceptability
arm group label: Sleepwell
arm group type: Experimental
description: Mailed information package includes 2 Sleepwell booklets (How to get your sleep back and How to stop sleeping pills)
arm group label: Empower
arm group type: Active Comparator
description: Mailed information package includes 2 Empower booklets (You may be at risk AND How to get a good night's sleep without sleeping pills)
arm group label: TAU
arm group type: No Intervention
description: Treatment-as-usual group: no mailed intervention package.
intervention type: Behavioral
intervention name: Sleepwell
description: Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.
arm group label: Sleepwell
intervention type: Behavioral
intervention name: Empower
description: Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.
arm group label: Empower
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: David M Gardner, PharmD
role: Principal Investigator
affiliation: Dalhousie University
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Dalhousie University
investigator full name: David Gardner
investigator title: Professor
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No