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Trial record 66 of 73 for:    aromatherapy

At-Home Olfactory Training

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ClinicalTrials.gov Identifier: NCT03611673
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
The purpose of this study is to determine the impact of a twice daily at-home olfactory training program with a twenty scent, essential oil-based smell test in patients with olfactory dysfunction.

Condition or disease Intervention/treatment Phase
Olfactory Disorder Other: Smell Test Not Applicable

Detailed Description:
This study randomizes participants to receive either a four scent or fourteen scent olfactory retraining protocol. Baseline olfaction will be tested with a currently commercially available smell test as well as an essential oil based smell test. The protocol involves twice daily retraining where the participant inhales the scent and makes a mental note of what they should be smelling. The training period is six months total with a visit at 3 months to re-assess smell function as well as at six months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: At-Home Olfactory Training With Essential-Oil Based Scents
Actual Study Start Date : June 2, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Group A: 15 Scents
Participants will be asked to inhale 15 different scents two times a day.
Other: Smell Test
Oils are used for each of the different scents. Each scent will be put on an aromatherapy inhaling stick.

Active Comparator: Group B: 4 Scents
Participants will be asked to inhale 4 different scents two times a day.
Other: Smell Test
Oils are used for each of the different scents. Each scent will be put on an aromatherapy inhaling stick.




Primary Outcome Measures :
  1. Change in ability to detect odorants - Sniffin' Sticks [ Time Frame: Change from Baseline to Month 6 ]
    Sniffin Sticks are a battery of 12 scents within a tube. The subject smells each scent and then chooses from 4 multiple choice options which is the scent they smelled. Increased number of correct responses indicates better sense of smell. 12/12 is the maximum score. 0/12 is the minimum score.

  2. Change in ability to detect odorants - AROMA [ Time Frame: Change from Baseline to Month 6 ]
    AROMA is a essential oil based test. The subject is asked to respond if they detect a smell. If yes, they proceed to a 4 multiple choice items and select the item the smell. If no, they proceed to the next item. Higher number correct indicates better sense of smell. It consists of 13 odorants and 1 blank. Improved sense of smell would also increase the number of correctly identified odorants out of the 14 (including noting the 1 blank).


Secondary Outcome Measures :
  1. Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS) [ Time Frame: Change from Baseline to Month 6 ]
    The QOD-NS includes 17 statements that are graded on a scale from 0 to 3. Total score ranges from 0 to 51. Higher QOD-NS scores reflect better quality of life.

  2. SF-12 (Short Form Health Survey) [ Time Frame: Change from Baseline to Month 6 ]
    SF-12 is a validated general measure of quality of life instrument that includes physical and mental scales. There are a total of 12 questions. Each aspect of the scale is weighted differently to yield a composite score. In general, a higher score is associated with better health.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have clinical olfactory dysfunction

Exclusion Criteria:

  • Pregnant women
  • Unable to perform routine follow-up
  • Current participation in another clinical trial during this trial
  • Patients with dementia, Alzheimer's disease, Parkinson's disease, or other neurocognitive disorders
  • Diagnosis of other systemic conditions known to impact the sinonasal cavity such as Wegener's granulomatosis, Churg Strauss, and immunodeficiency
  • Patients who are allergic to any of the smells or components of our olfactory testing
  • Chronic rhinosinusitis, malignant tumors and/or oncologic therapies (radiation/chemotherapy)
  • History of surgery on the nose or paranasal sinuses
  • Patients using medications that may impact olfactory function (i.e. corticosteroids)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611673


Contacts
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Contact: Kevin Sykes, PhD, MPH 913-588-7154 ksykes@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Jennifer Villwock, MD University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03611673     History of Changes
Other Study ID Numbers: STUDY00141820
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Kansas Medical Center:
sense of smell
smell test
at-home smell test
essential oil
olfactory loss