Randomized Clinical Trial of Intranasal Injection of Platelet-Rich Plasma for Treatment of Parosmia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Sniffin Sticks Parosmia Test (SSParoT)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Saline
Participants receive saline injections into the olfactory cleft three times, separated by two weeks each. (Sham/placebo injections).
干预措施: Saline (Other)
Platelet Rich Plasma (PRP)
Participants receive PRP intranasal injection into the olfactory cleft three times, separated by two weeks each. Blood is drawn from the patient. This is placed in a centrifuge and using a specialized PRP kit (Emcyte), the sequential spinning process isolates the platelet-rich plasma portion of the blood and we inject that back into the patient within the nasal cavity.
干预措施: Platelet-rich Plasma (PRP) (Other)
结局指标
主要结局
Change in Sniffin Sticks Parosmia Test (SSParoT)
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Zara M. Patel
Professor
Stanford University