<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/NCT02980718</url>
  </required_header>
  <id_info>
    <org_study_id>2016/837</org_study_id>
    <nct_id>NCT02980718</nct_id>
  </id_info>
  <brief_title>Does Olfactory Training Improve Olfaction in a Population With Normal Sense of Smell?</brief_title>
  <official_title>Does Olfactory Training Improve Olfaction in a Population With Normosmia and How is Their Self Assessment of Sense of Smell?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Olavs Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Olavs 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>
      Awareness of the sense of smell in the western population has been low. Most people do not&#xD;
      think about the consequences of absence of smell (anosmia). Reduction in sense of smell&#xD;
      (hyposmia) can influence everyday life. In situations of stress anosmia can be life&#xD;
      threatening for example when there is a fire. Cooks may lose their job. Not being able to&#xD;
      enjoy food and drink interferes with quality of life. The causes of olfactory dysfunction&#xD;
      (OD) vary. Most often OD is associated with upper respiratory tract infections, disease of&#xD;
      the nose and sinuses or head injuries. OD may be congenital, age related or associated with&#xD;
      neurological disorders. Hyposmia occurs in up to 85% of cases of Parkinson's and may be the&#xD;
      first symptom of both Parkinson's and Alzheimer's disease several years before the mental&#xD;
      changes occur.&#xD;
&#xD;
      Knowledge and focus on OD has until recently been low among most physicians and treatment&#xD;
      options have often not been available. Different approaches to improve OD have been tried&#xD;
      with variable effect depending on the cause of OD. There are studies on corticosteroids, zinc&#xD;
      gluconate and vitamin A. In recent years, olfactory training has been launched as a promising&#xD;
      treatment option. Most studies with olfactory training are done with patients with OD. A&#xD;
      recently published review describes 10 studies with olfactory training among 639 patients and&#xD;
      concludes that daily stimulation with odorants (odor concentrate) over a limited period time&#xD;
      is a promising treatment. The suggested duration of olfactory training varies from 3 to 14&#xD;
      months. Different intensities of olfactory training were compared in patients with post-viral&#xD;
      OD. Olfaction was more improved by the high concentration of odorant than by the low&#xD;
      concentration.&#xD;
&#xD;
      A small number of studies have shown that the olfactory nerve to some extent can be trained&#xD;
      in persons with normal sense of smell, but we need more experience and structured studies to&#xD;
      be able to conclude with greater certainty about the effect of olfactory training in this&#xD;
      population.&#xD;
&#xD;
      This study examines whether intensive olfactory training improves the sense of smell more&#xD;
      than ordinary olfactory training in subjects with normal olfaction (normosmia) and examines&#xD;
      self-evaluation of olfactory function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sub-study: Part of the participants (45/200) will be included in a pilot study which will be&#xD;
      an analytical observational study to compare olfactory bulb volume measured on MRI three&#xD;
      times during a year, while at the same time resting state fMRI will be measured before and&#xD;
      after olfactory training. There is not sufficient data in the literature for power&#xD;
      calculations and this sub-study is therefore a pilot study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>olfaction assessed by TDI-score according to extended Sniffin'Sticks</measure>
    <time_frame>4 months (immediately after completion of the training period)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>olfaction self-evaluated and reported in a questionnaire</measure>
    <time_frame>4 months (immediately after completion of the training period)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>olfaction assessed byTDI-score according to extended Sniffin'Sticks</measure>
    <time_frame>1 year (6-7 months after completion of the training period)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>olfaction self-evaluated and reported in a questionnaire</measure>
    <time_frame>1 year (6-7 months after completion of the training period)</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>People With Normal Sense of Smell</condition>
  <arm_group>
    <arm_group_label>intensive olfactory training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>90 participants will undergo intensive olfactory training. They will sniff on four selected odors (10 seconds on each odor bottle in a total of 4 minutes) every morning and evening for 3 months and they will be instructed in the principles of the logbook for olfactory training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ordinary olfactory training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>90 participants will undergo ordinary olfactory training. They will sniff on four selected odors (10 seconds on each odor bottle in a total of 40 seconds) every morning and evening for 3 months and they will be instructed in the principles of the logbook for olfactory training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>20 participants represent a control group with no olfactory training</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>intensive olfactory training</intervention_name>
    <arm_group_label>intensive olfactory training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ordinary olfactory training</intervention_name>
    <arm_group_label>ordinary olfactory training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  TDI score &gt; 30.5 measured by Sniffin'Sticks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to follow the olfactory training or follow-up (language, practical&#xD;
             implementation, mental condition)&#xD;
&#xD;
          -  Disease affecting olfaction (sinusitis, pronounced allergies, recent nasal surgery,&#xD;
             Alzheimer's, Parkinson, MS, COPD)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ståle Nordgård, md prof</last_name>
    <role>Study Director</role>
    <affiliation>Norwegian University of Science and Technology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marit Fagerli, md</last_name>
    <role>Study Director</role>
    <affiliation>St Olavs Hospital, Klinikk for Øre Nese Hals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Olavs Hospital, Klinikk ØNH</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <reference>
    <citation>Katotomichelakis M, Balatsouras D, Tripsianis G, Tsaroucha A, Homsioglou E, Danielides V. Normative values of olfactory function testing using the 'sniffin' sticks'. Laryngoscope. 2007 Jan;117(1):114-20. doi: 10.1097/01.mlg.0000246518.79894.7e.</citation>
    <PMID>17202939</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>May 8, 2020</last_update_submitted>
  <last_update_submitted_qc>May 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Olfaction training</keyword>
  <keyword>Smell</keyword>
  <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/NCT02980718
org study id: 2016/837
nct id: NCT02980718
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Awareness of the sense of smell in the western population has been low. Most people do not
      think about the consequences of absence of smell (anosmia). Reduction in sense of smell
      (hyposmia) can influence everyday life. In situations of stress anosmia can be life
      threatening for example when there is a fire. Cooks may lose their job. Not being able to
      enjoy food and drink interferes with quality of life. The causes of olfactory dysfunction
      (OD) vary. Most often OD is associated with upper respiratory tract infections, disease of
      the nose and sinuses or head injuries. OD may be congenital, age related or associated with
      neurological disorders. Hyposmia occurs in up to 85% of cases of Parkinson's and may be the
      first symptom of both Parkinson's and Alzheimer's disease several years before the mental
      changes occur.

      Knowledge and focus on OD has until recently been low among most physicians and treatment
      options have often not been available. Different approaches to improve OD have been tried
      with variable effect depending on the cause of OD. There are studies on corticosteroids, zinc
      gluconate and vitamin A. In recent years, olfactory training has been launched as a promising
      treatment option. Most studies with olfactory training are done with patients with OD. A
      recently published review describes 10 studies with olfactory training among 639 patients and
      concludes that daily stimulation with odorants (odor concentrate) over a limited period time
      is a promising treatment. The suggested duration of olfactory training varies from 3 to 14
      months. Different intensities of olfactory training were compared in patients with post-viral
      OD. Olfaction was more improved by the high concentration of odorant than by the low
      concentration.

      A small number of studies have shown that the olfactory nerve to some extent can be trained
      in persons with normal sense of smell, but we need more experience and structured studies to
      be able to conclude with greater certainty about the effect of olfactory training in this
      population.

      This study examines whether intensive olfactory training improves the sense of smell more
      than ordinary olfactory training in subjects with normal olfaction (normosmia) and examines
      self-evaluation of olfactory function.
Sub-study: Part of the participants (45/200) will be included in a pilot study which will be
      an analytical observational study to compare olfactory bulb volume measured on MRI three
      times during a year, while at the same time resting state fMRI will be measured before and
      after olfactory training. There is not sufficient data in the literature for power
      calculations and this sub-study is therefore a pilot study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: olfaction assessed by TDI-score according to extended Sniffin'Sticks
time frame: 4 months (immediately after completion of the training period)
measure: olfaction self-evaluated and reported in a questionnaire
time frame: 4 months (immediately after completion of the training period)
measure: olfaction assessed byTDI-score according to extended Sniffin'Sticks
time frame: 1 year (6-7 months after completion of the training period)
measure: olfaction self-evaluated and reported in a questionnaire
time frame: 1 year (6-7 months after completion of the training period)
arm group label: intensive olfactory training
arm group type: Experimental
description: 90 participants will undergo intensive olfactory training. They will sniff on four selected odors (10 seconds on each odor bottle in a total of 4 minutes) every morning and evening for 3 months and they will be instructed in the principles of the logbook for olfactory training.
arm group label: ordinary olfactory training
arm group type: Experimental
description: 90 participants will undergo ordinary olfactory training. They will sniff on four selected odors (10 seconds on each odor bottle in a total of 40 seconds) every morning and evening for 3 months and they will be instructed in the principles of the logbook for olfactory training.
arm group label: controls
arm group type: No Intervention
description: 20 participants represent a control group with no olfactory training
intervention type: Behavioral
intervention name: intensive olfactory training
arm group label: intensive olfactory training
intervention type: Behavioral
intervention name: ordinary olfactory training
arm group label: ordinary olfactory training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Ståle Nordgård, md prof
role: Study Director
affiliation: Norwegian University of Science and Technology
last name: Marit Fagerli, md
role: Study Director
affiliation: St Olavs Hospital, Klinikk for Øre Nese Hals
facility: 
country: Norway
citation: Katotomichelakis M, Balatsouras D, Tripsianis G, Tsaroucha A, Homsioglou E, Danielides V. Normative values of olfactory function testing using the 'sniffin' sticks'. Laryngoscope. 2007 Jan;117(1):114-20. doi: 10.1097/01.mlg.0000246518.79894.7e.
PMID: 17202939
responsible party type: Sponsor
sharing ipd: No