Efficacy of the EarPopper Device in Children With Recurrent Otitis Media: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of AOM
研究概览
简要总结
This is a randomized controlled clinical trial evaluating the efficacy of the EarPopper device (EP) in the reduction of episodes of acute otitis media (AOM) in children with recurrent otitis media. The control arm will be observational. The intervention arm will have the EP used.
详细描述
The hypothesis of this randomized controlled trial is that the EP device will be able to prophylactically decrease incidence of AOM in children with recurrent AOM. The secondary hypothesis is that the EP device will be able to decrease morbidity of AOM and severity of AOM in children with recurrent AOM (by measuring quality of life and associated endpoints).
The EP device is 510(K) regulated (510(K) Number K073401) as a non-surgical, non-drug related treatment for middle ear pressure problems such as: Middle ear fluid (Otitis Media with Effusion), Eustachian Tube Dysfunction, Temporary hearing loss, Ear pain and pressure caused by air travel, Ear fullness caused by colds, allergies and sinusitis.
This is a randomized, controlled, double blinded study. This is a randomized controlled clinical trial evaluating the efficacy of the EarPopper device (EP) in the reduction of episodes of acute otitis media (AOM) in children with recurrent otitis media. The control arm will be observational.
Patients will be followed up for a period of one year, and monthly telephone call interviews will be conducted.
All patients will receive the EarPopper device for participation in this trial (for the control arm, they will receive the device at the end of their study follow up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Since there will be no dummy devices in this trial, we will be unable to blind the patients and physicians to whom is using the EP device. The assessors/data collectors will be blinded for patient follow-up, and the statistician will be blinded. Therefore this will be a double blinded study.
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form from parent, plus assent form (if age appropriate)
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 4-11
- •Diagnosed with recurrent AOM, defined as: least 2 episodes of AOM within the preceding year of date of screening
- •Must be able to follow directions to use EarPopper, or have a caregiver able to administer the device.
- •Patient must be currently free of middle ear effusion or current acute OM. This will be determined on physical examination during screening visit
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Patient with chronic middle ear effusion.
- •Patients with potential complications or confounding conditions: asthma, chronic sinusitis, immunodeficiency, diabetes mellitus
- •Patient with cleft palate.
研究组 & 干预措施
Intervention Arm: EarPopper
All patients in this arm will receive the EarPopper device.
Length of administration: 1 year Dose: Dosing of the EP device will be twice per day, once in the morning and once before bedtime. This is consistent with previous dosing which showed no adverse events and an excellent safety profile. 5, 6
Administration:
- Hold nosepiece firmly against nostril opening creating a good, tight seal is crucial. Plug the other nostril closed.
- Push button to start the airflow and swallow while the device is running.
- Repeat on other nostril. After 5 minutes, repeat steps 1 - 3. This will complete one treatment.
Telephone call survey:
Will be administered monthly by study investigator. Telephone call survey is based on the OMO-22 Form.
干预措施: EarPopper (Device)
Control
All patients in this arm will not receive any intervention. EarPopper device will be given to this group at the end of follow-up period (1 year)
Telephone call survey:
Will be administered monthly by study investigator. Telephone call survey is based on the OMO-22 Form.
结局指标
主要结局
Incidence of AOM
时间窗: 1 year
Null Hypothesis: The incidence of AOM is the same between two arms of the study. Description: Definition of AOM will be presence of AOM documented in the clinic notes during the follow-up period. This is a binary data point. Test: chi-square test with a 0.05 two-sided significance level
次要结局
- Proportion of patients without AOM and antibiotics use(1 year)
- Hazard ratio of time to AOM(1 year)
- Otitis Media Outcome-22 (OMO-22) form and questionnaire(1 year)
研究者
Tristan Tham
Research Scientist
Northwell Health