NCT06283745 · Stanford University
Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia
What this study is about
This randomly assigned 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.
View original scientific description
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
OTHER
Platelet-rich Plasma (PRP)
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.
OTHER
Saline
Saline intranasal injection (sham injection)
Primary outcome measures
Change in Sniffin Sticks Parosmia Test (SSParoT)
Time frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Palo Alto, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 22, 2024 · Source of record for eligibility and locations