Prospective Randomized Study of the Treatment of Pediatric Patients That Lost Sense of Smell Due to COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to First Follow-up
研究概览
简要总结
This research study is a randomized controlled trial in pediatric and young adult patients who have lost their sense of smell due to COVID-19 viral infection. The goals are:
- to learn more about the effects of smell retraining therapy on smell loss following COVID-19 and
- to determine if budesonide-saline irrigations make smell retraining therapy more effective.
详细描述
Researchers will screen all potentially eligible patients that have 'loss of smell' as their reason for visit at UPMC Children's Hospital of Pittsburgh Division of Pediatric Otolaryngology.
At the initial consult appointment at the Division of Pediatric Otolaryngology, listed study team members will perform a smell identification test called the UPSIT (University of Pennsylvania Smell Identification Test) and give the SNOT-22 (Sino-Nasal Outcome Test-22) survey. The UPSIT is a 40-item scratch and sniff test with a four-choice multiple choice question on each of the 10 pages in the booklet. Indication of smell loss can be determined - anosmia (total loss) and mild, moderate, or severe microsomia and a detection for malingering. The SNOT-22 is a 22 question survey that asks about symptoms and social/emotional consequences of a nasal disorder. The survey is on a 6 point scale - No problem (0), very mild problem (1), mild or slight problem (2), moderate problem (3), severe problem (4), and problem as bad as it can be (5).
A randomized clinical trial will be performed with two arms for those that have lost their sense of smell for at least 8 weeks: 1) smell retraining for 8 weeks 2) smell retraining + Budesonide irrigations for 8 weeks. Smell retraining consists of choosing 4 scents each week and smelling each item for 15 seconds very close to the nose once a day. Budesonide irrigations will be done once a day by pouring 0.5mg/2ml of Budesonide into a irrigation bottle with saline and irrigating the nose. Participants may do the therapies at any point during the day.
Children and young adults ages 6 to 21 will be enrolled with 30 children block randomized in each arm, in which up to 10 children in each arm will be those who did not have a positive COVID-19 antigen test or confirmed COVID-19 by history. COVID-19 testing will be used for randomization purposes, but will not be limited to testing due to the inclusion of confirmation by history.
Two groups of subjects for study inclusion:
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
- None
入排标准
- 年龄范围
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ages 6 to 21 who have loss of smell (anosmia) or dysosmia (disordered smell perception) and thought to have occurred due to COVID-
- •Subjects who are able to complete the smell test (UPSIT), self-report their loss of smell, and do the assigned daily therapy.
排除标准
- •Duration of anosmia or dysosmia <60 days
- •Previous smell retraining
- •Prior interventions for loss of smell (excluding those on Flonase and Azelastine)
- •Contraindications for nasal budesonide treatment, as determined by the treating physician
- •Active cigarette smoker or use of vapes
- •Previous head trauma
- •Congenital anosmia
- •History of brain tumor
- •Neurocognitive disorders
- •Multiple sclerosis
- •Seizure disorder
- •Cystic fibrosis
- •Primary Ciliary Dyskinesia
- •History of nasal polyps
- •Inability to self-report
研究组 & 干预措施
Smell Retraining + Budesonide
Participants will undergo smell retraining as described above. They will also complete budesonide irrigations once a day by pouring 0.5mg/2ml of budesonide into a irrigation bottle with saline and irrigating the nose.
干预措施: Smell Retraining (Other)
Smell Retraining + Budesonide
Participants will undergo smell retraining as described above. They will also complete budesonide irrigations once a day by pouring 0.5mg/2ml of budesonide into a irrigation bottle with saline and irrigating the nose.
干预措施: Budesonide (Drug)
Smell Retraining Only
Participants will undergo smell retraining for 8 weeks. Each week, participants will choose 4 scents. They will smell each item for 15 seconds very close to the nose once a day.
干预措施: Smell Retraining (Other)
结局指标
主要结局
Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to First Follow-up
时间窗: Before and after 8-12 weeks of smell retraining
Change in University of Pennsylvania Smell Identification Test (UPSIT) score from baseline at the initial consult appointment to the first follow-up appointment at 8 weeks (range 8 to 12 weeks). The UPSIT is a smell identification test and is a 40-item scratch and sniff test with a four-choice multiple choice question on each of the 10 pages in the booklet. Indication of smell loss can be determined - anosmia (total loss) and mild, moderate, or severe microsomia and a detection for malingering. The minimum possible score is a 0 and the maximum is a 40. A higher score indicates better smell/outcome.
次要结局
- Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to 6 Month Follow-up(Baseline and 6 months after initial consult appointment)
- Change in Sino-nasal Outcome Test-22 (SNOT-22) Score From Baseline to 12 Month Follow-up(Baseline and 12 months after initial consult appointment)
- Change in University of Pennsylvania Smell Identification Test (UPSIT) Score From Baseline to 12 Month Follow-up(Baseline and 12 months after initial consult appointment)
- Change in Sino-nasal Outcome Test-22 (SNOT-22) Score From Baseline to First Follow-up(Before and after 8-12 weeks of smell retraining)
- Change in Loss of Smell Question Score From Baseline to First Follow-up(Before and after 8-12 weeks of smell retraining)
- Change in Sino-nasal Outcome Test-22 (SNOT-22) Score From Baseline to 6 Month Follow-up(Baseline and 6 months after initial consult appointment)
研究者
Amanda Stapleton
Assistant Professor
University of Pittsburgh