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Olfactory Training for Loss of Smell

N/A
Recruiting
Led By Nicholas Rowan, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Preoperative diagnosis of benign sellar or parasellar skull base pathology
Be older than 18 years old
Must not have
History of chronic rhinosinusitis
History of gastrectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative

Summary

This trial seeks to understand the effects of surgery on smell and taste and test a potential treatment to hasten recovery.

Who is the study for?
This trial is for English-speaking individuals with benign tumors at the base of their skull who haven't had previous surgeries or treatments in that area, no history of chronic sinus issues, neurocognitive disorders, or intrinsic problems with smell and taste. Those with pacemakers, gastrectomy, or malignant tumors are excluded.
What is being tested?
The study tests if olfactory training after surgery can improve the sense of smell and quality of life faster compared to a placebo training. It's designed to understand how surgery affects smell and taste and whether specific postoperative exercises can help recovery.
What are the potential side effects?
Since this trial involves non-invasive olfactory training rather than medication or surgical intervention, significant side effects are not anticipated. However, participants may experience frustration or fatigue from regular sensory exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a non-cancerous tumor near the base of my skull.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a long-term history of sinus infections.
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I have had surgery to remove all or part of my stomach.
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I have been diagnosed with a cancerous tumor near the base of my skull.
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I have had sinus surgery.
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I have had surgery on the base of my skull.
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I have had radiation or other treatments for issues in my face, nose, or skull.
Select...
I have a history of taste or smell disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operative visit (baseline), 2 weeks post-operative, 1 month post-operative, 3 months post-operative, 6 months post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Olfactory function as assessed by the Sniffin Sticks olfactory testing kit
Secondary study objectives
Change in Quality of Life as assessed by the Anterior Skull Base Nasal Inventory-12
Change in Quality of Life as assessed by the ODOR (Olfactory Dysfunction Outcomes Rating) questionnaire
Change in Quality of Life as assessed by the Skull Base Inventory
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Participants receive treatment olfactory training kits that contain essential oils that have scents (lavender, lemon, clove, eucalyptus)
Group II: PlaceboPlacebo Group1 Intervention
Participants receive placebo olfactory training kits that only contain medium chain triglycerides that lack any discernible odor

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,581 Total Patients Enrolled
North American Skull Base SocietyOTHER
1 Previous Clinical Trials
60 Total Patients Enrolled
Nicholas Rowan, MDPrincipal InvestigatorJohns Hopkins School of Medicine

Media Library

Treatment Clinical Trial Eligibility Overview. Trial Name: NCT05912881 — N/A
Skull Base Tumors Research Study Groups: Placebo, Treatment
Skull Base Tumors Clinical Trial 2023: Treatment Highlights & Side Effects. Trial Name: NCT05912881 — N/A
Treatment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05912881 — N/A
~17 spots leftby Jan 2026