<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/NCT04419792</url>
  </required_header>
  <id_info>
    <org_study_id>Cross Sectional</org_study_id>
    <nct_id>NCT04419792</nct_id>
  </id_info>
  <brief_title>'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'</brief_title>
  <official_title>'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Dublin, Trinity College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. James's Hospital, Ireland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Dublin, Trinity College</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>
      Narcolepsy is a sleep disorder characterised by excessive daytime sleepiness and&#xD;
      significantly impacts quality of life. People with narcolepsy demonstrate many potential&#xD;
      barriers to being physically active, such as sleepiness and social isolation. Very little is&#xD;
      known about how physical performance variables may be affected and influence disease&#xD;
      experience in people with narcolepsy. This study aims to profile the physical fitness and&#xD;
      physical functioning variables of adults with narcolepsy and to explore the relationship&#xD;
      between physical variables, quality of life, symptom severity and disease experience in this&#xD;
      cohort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to profile the physical functioning variables of people with narcolepsy&#xD;
      attending an outpatient clinic at St. James's Hospital. This will be accomplished by&#xD;
      ascertaining the cardiopulmonary fitness, physical activity, and muscle strength and&#xD;
      endurance of this population.&#xD;
&#xD;
      Secondary objectives of this study will be to explore the relationship between physical&#xD;
      performance indices and sleep quality, functional ability and quality of life in this&#xD;
      population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Recruitment for study has been suspended due to Covid-19.&#xD;
  </why_stopped>
  <start_date type="Actual">October 15, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 31, 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>Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)</measure>
    <time_frame>30 minutes</time_frame>
    <description>The submaximal Young Men's Christian Association (YMCA) exercise test utilises the relationship between workload and heart rate to predict maximal oxygen consumption. Provides indication of cardiopulmonary fitness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of grip strength</measure>
    <time_frame>15 minutes</time_frame>
    <description>Objective measure of grip strength of the dominant and non-dominant hands, and will provided indication of how grip strength compares to age and gender-matched norms. Dynamometry will be used to asses muscle strength of the upper limb.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of upper limb endurance</measure>
    <time_frame>10 minutes</time_frame>
    <description>The American College of Sports Medicine Press Up Test will be used to objectively measure muscular endurance of the upper limb. Identifies the maximum number of press ups that the participant can perform before failure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of lower limb endurance</measure>
    <time_frame>10 minutes</time_frame>
    <description>The wall sit test will be used to objectively measure lower limb endurance. Measures the duration a participant can maintain a wall sit until failure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of lower limb power.</measure>
    <time_frame>10 minutes</time_frame>
    <description>The Countermovement Jump Test will be used to objectively measure lower limb power. This test measures both jump height and peak power achieved by participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measurement of physical activity</measure>
    <time_frame>7 days</time_frame>
    <description>Actigraphy will be used to objectively measure physical activity and sedentary behaviour. Participant will be required to wear the actigraph around their waist during all waking hours except during swimming or bathing, and then send back to assessor in return-addressed envelopes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective measure of Health-Related Quality of Life</measure>
    <time_frame>10 minutes</time_frame>
    <description>Health-related quality of life will be subjectively assessed using the Short Form-36 questionnaire (Generic).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective measure of Health-Related Quality of Life (sleep-disorder-specific)</measure>
    <time_frame>10 minutes</time_frame>
    <description>Health-related quality of life will be subjectively assessed using the Functional Outcomes of Sleep Questionnaire questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective measure of symptom severity</measure>
    <time_frame>10 minutes</time_frame>
    <description>Symptom severity will be subjectively assessed through use of the Narcolepsy Severity Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective measure of daytime sleepiness</measure>
    <time_frame>5 minutes</time_frame>
    <description>Daytime sleepiness will be subjectively assessed through use of the Epworth Sleepiness Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective measure of physical activity</measure>
    <time_frame>5 minutes</time_frame>
    <description>Physical activity levels will be subjectively assessed through use of Physical Activity Vital Sign questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective measure of sedentary behaviour</measure>
    <time_frame>5 minutes</time_frame>
    <description>Sedentary behaviour levels will be subjectively assessed through use of Sedentary Behaviour Questionnaire.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Narcolepsy</condition>
  <condition>Narcolepsy 1</condition>
  <condition>Narcolepsy Type 1</condition>
  <condition>Narcolepsy With Cataplexy</condition>
  <condition>Narcolepsy Without Cataplexy</condition>
  <condition>Narcolepsy and Hypersomnia</condition>
  <condition>Hypersomnolence</condition>
  <arm_group>
    <arm_group_label>Narcolepsy</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Assessment of physical performance variables</intervention_name>
    <description>Other:&#xD;
Assessment of physical performance indices using the following outcome measures:&#xD;
Cardiopulmonary fitness: YMCA submaximal bike test Upper Body: ACSM press up test, Dynamometry Lower body: Wall squat test, Countermovement jump test</description>
    <arm_group_label>Narcolepsy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The following eligibility criteria: Aged 18 to 65 years, diagnosis of type 1 or type 2&#xD;
        narcolepsy based on the International Classification of Sleep Disorders third edition&#xD;
        criteria for at least six months, eligibility screened by their treating clinician, and&#xD;
        able to understand English and follow simple instruction to enable completion of&#xD;
        assessments. Additionally, participants will be required to provide signed and informed&#xD;
        consent to participate in the study, and for processing of their data to be eligible for&#xD;
        participation. Individuals with sleep disorders other than narcolepsy, contraindications to&#xD;
        moderate-intensity exercise, confirmed pregnancy or significant psychiatric illness or&#xD;
        cognitive impairment will be excluded from participating in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients diagnosed with narcolepsy type 1 or type 2 based on the International&#xD;
             Classification of Sleep Disorders, third edition (ICSD-3) criteria for at least 6&#xD;
             months - diagnosis for at least 6 months will ensure that initial fluctuations due to&#xD;
             likely starting on new drug regimen are relatively stable.&#xD;
&#xD;
          2. Eligibility screened and agreement of the participant's treating clinician in&#xD;
             Narcolepsy out-patient clinic of St. James's Hospital that he/she can participate - to&#xD;
             ensure that as per General Data Protection Regulation guidelines that the treating&#xD;
             clinician eligibility screens rather than the physiotherapy study researcher.&#xD;
&#xD;
          3. Patients aged ≥18 to &lt;65 years at the time of obtaining informed consent - as patients&#xD;
             &gt;18 years will not been seen in this centre, and patients &gt;65 years may have&#xD;
             age-related changes in cardiovascular fitness and physical activity which may be&#xD;
             difficult to separate from those pertaining to narcolepsy diagnosis.&#xD;
&#xD;
          4. Able to understand English - as questionnaires will necessitate a sufficient level of&#xD;
             English for completion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with sleep disorders other than narcolepsy (e.g., moderate to severe sleep&#xD;
             apnea syndrome, moderate to severe periodic limb movement disorder) - so results are&#xD;
             not diluted by including conditions other than narcolepsy.&#xD;
&#xD;
          2. Any medical contraindication to exercise of moderate intensity and short duration&#xD;
             including but not limited to cardiovascular or respiratory conditions, morbid obesity,&#xD;
             and severe osteoarthritis of the lower extremities - as these conditions would&#xD;
             preclude ability to conduct physical test battery.&#xD;
&#xD;
          3. Confirmed pregnancy - people with an advanced pregnancy may score differently on&#xD;
             physical functioning/performance tests, people with a confirmed pregnancy will be&#xD;
             excluded from study participation to limit bias.&#xD;
&#xD;
          4. Dementia or significant cognitive impairment or psychiatric illness that would&#xD;
             preclude ability to participate in study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Department of Physiotherapy, School of Medicine, Trinity College Dublin</name>
      <address>
        <city>Dublin</city>
        <zip>D08 W9RT</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Dublin, Trinity College</investigator_affiliation>
    <investigator_full_name>Ragy Tadrous</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <keyword>Physical performance</keyword>
  <keyword>Cardiopulmonary fitness</keyword>
  <keyword>Muscle strength</keyword>
  <keyword>Muscle endurance</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Narcolepsy</mesh_term>
    <mesh_term>Disorders of Excessive Somnolence</mesh_term>
    <mesh_term>Cataplexy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>In keeping with the research policy of Trinity College Dublin, relevant and anonymised data and materials will be made available through Trinity College's Access to Research Archive (TARA) data depository.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </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/NCT04419792
org study id: Cross Sectional
nct id: NCT04419792
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Narcolepsy is a sleep disorder characterised by excessive daytime sleepiness and
      significantly impacts quality of life. People with narcolepsy demonstrate many potential
      barriers to being physically active, such as sleepiness and social isolation. Very little is
      known about how physical performance variables may be affected and influence disease
      experience in people with narcolepsy. This study aims to profile the physical fitness and
      physical functioning variables of adults with narcolepsy and to explore the relationship
      between physical variables, quality of life, symptom severity and disease experience in this
      cohort.
This study aims to profile the physical functioning variables of people with narcolepsy
      attending an outpatient clinic at St. James's Hospital. This will be accomplished by
      ascertaining the cardiopulmonary fitness, physical activity, and muscle strength and
      endurance of this population.

      Secondary objectives of this study will be to explore the relationship between physical
      performance indices and sleep quality, functional ability and quality of life in this
      population.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Measurement of oxygen uptake during cardiopulmonary exercise testing (% predicted)
time frame: 30 minutes
description: The submaximal Young Men's Christian Association (YMCA) exercise test utilises the relationship between workload and heart rate to predict maximal oxygen consumption. Provides indication of cardiopulmonary fitness.
measure: Measurement of grip strength
time frame: 15 minutes
description: Objective measure of grip strength of the dominant and non-dominant hands, and will provided indication of how grip strength compares to age and gender-matched norms. Dynamometry will be used to asses muscle strength of the upper limb.
measure: Measurement of upper limb endurance
time frame: 10 minutes
description: The American College of Sports Medicine Press Up Test will be used to objectively measure muscular endurance of the upper limb. Identifies the maximum number of press ups that the participant can perform before failure.
measure: Measurement of lower limb endurance
time frame: 10 minutes
description: The wall sit test will be used to objectively measure lower limb endurance. Measures the duration a participant can maintain a wall sit until failure.
measure: Measurement of lower limb power.
time frame: 10 minutes
description: The Countermovement Jump Test will be used to objectively measure lower limb power. This test measures both jump height and peak power achieved by participants.
measure: Measurement of physical activity
time frame: 7 days
description: Actigraphy will be used to objectively measure physical activity and sedentary behaviour. Participant will be required to wear the actigraph around their waist during all waking hours except during swimming or bathing, and then send back to assessor in return-addressed envelopes.
measure: Subjective measure of Health-Related Quality of Life
time frame: 10 minutes
description: Health-related quality of life will be subjectively assessed using the Short Form-36 questionnaire (Generic).
measure: Subjective measure of Health-Related Quality of Life (sleep-disorder-specific)
time frame: 10 minutes
description: Health-related quality of life will be subjectively assessed using the Functional Outcomes of Sleep Questionnaire questionnaires
measure: Subjective measure of symptom severity
time frame: 10 minutes
description: Symptom severity will be subjectively assessed through use of the Narcolepsy Severity Scale.
measure: Subjective measure of daytime sleepiness
time frame: 5 minutes
description: Daytime sleepiness will be subjectively assessed through use of the Epworth Sleepiness Scale.
measure: Subjective measure of physical activity
time frame: 5 minutes
description: Physical activity levels will be subjectively assessed through use of Physical Activity Vital Sign questionnaire.
measure: Subjective measure of sedentary behaviour
time frame: 5 minutes
description: Sedentary behaviour levels will be subjectively assessed through use of Sedentary Behaviour Questionnaire.
arm group label: Narcolepsy
intervention type: Other
intervention name: Assessment of physical performance variables
description: Other:
Assessment of physical performance indices using the following outcome measures:
Cardiopulmonary fitness: YMCA submaximal bike test Upper Body: ACSM press up test, Dynamometry Lower body: Wall squat test, Countermovement jump test
arm group label: Narcolepsy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
facility: 
country: Ireland
responsible party type: Principal Investigator
investigator affiliation: University of Dublin, Trinity College
investigator full name: Ragy Tadrous
investigator title: PhD Student
mesh term: Narcolepsy
mesh term: Disorders of Excessive Somnolence
mesh term: Cataplexy
sharing ipd: Yes
ipd description: In keeping with the research policy of Trinity College Dublin, relevant and anonymised data and materials will be made available through Trinity College's Access to Research Archive (TARA) data depository.
ipd info type: Study Protocol