Paraosmia
Conditions
Brief summary
This randomized clinical trial will evaluate the benefit of platelet-rich plasma (PRP) in the treatment of qualitative olfactory dysfunction (parosmia). PRP can be isolated from a patient's own blood and has been found in previous studies to have anti-inflammatory and pro-regenerative properties. It has been used across multiple specialties, such as Orthopedics, Facial Plastics, Dermatology, Neurology in injected form to treat a wide variety of tissues to encourage the body's inherent regenerative capacity. The investigators have completed a randomized controlled trial here, ending in 2022, evaluating it's use in post-SARS-CoV-2 olfactory loss which demonstrated safety and efficacy. Therefore, the investigators aim to assess the ability of PRP to improve olfactory function in patients with parosmia.
Interventions
Platelet-rich plasma (PRP) intranasal injection in the treatment of qualitative olfactory dysfunction (parosmia). This is taken from a blog draw from the patient themselves, and thus no external drug/biologic product will be given - only the concentrated plasma portion from the patient's own blood.
OTHERSaline
Saline intranasal injection (sham injection)
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
PRP injections will be given to one arm while sham saline injections will be given to the other arm.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients \>= 18 years of age * Patients who have qualitative olfactory distortion * Etiology of qualitative olfactory distortion is due to upper respiratory infection * Quantitative score under the 10th percentile on the SSParoT (HedRang and HedDir) * Quantitative score ≥ 8 on the QOD. * At least 6 months of parosmia but less than 24 months * Patients can have been previously treated with oral and topical steroids but this is not a requirement * Patients will receive concurrent olfactory training - the practice of smelling strong odors (standard of care) * Be able to read and understand English * Be able and willing to provide Informed Consent
Exclusion criteria
* Patients \< 18 years of age, pregnant females, patients who have structural abnormalities on nasal endoscopy or radiographic imaging that would prevent injection into the olfactory cleft * Olfactory loss due to trauma, chronic sinusitis / inflammation / polyps, neoplasms, or neurodegenerative diseases or patients who have had olfactory loss \> 24 months * Patients with bleeding disorders or on blood thinners such as coumadin and plavix
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sniffin Sticks Parosmia Test (SSParoT) | Assessed at baseline, 1 month, and 3 months | The test consists of a total of 22 sticks, 11 of which are pleasant odors and 11 of which are unpleasant odors. In this test, the test subject is offered a pair of sticks, 1 with an unpleasant odor and 1 with a pleasant odor. The SSParoT is the first test to measure qualitative olfactory function. This test uses hedonic estimates of two oppositely odors (pleasant and unpleasant) to assess the Hedonic Range (HR) and Hedonic Direction (HD). These values represent the qualitative olfactory perception. |
| Change in questionnaire of olfactory disorders (QOD) scale score | Assessed at baseline, 1 month, and 3 months | The QOD is a 25-item validated instrument in the measurement of olfactory-specific QOL (total score on 75) described by Hummel et al. Patients will undergo nasal endoscopy as part of their initial standard of care appointment to exclude structural causes of smell loss including mass or tumor, as well as ensuring there is no structural obstruction to the olfactory cleft such as severe septal deviation. |
Countries
United States
Contacts
Primary ContactHomer Abaya, BS
Backup ContactMaxime Fieux, MD, PhD
Outcome results
None listed