Evaluation of the Efficacy and Safety of Vibroacoustic Therapy With Oscillating Positive Expiratory Pressure in the Treatment of Nasal Congestion: A Randomized, Double-Blind, Placebo-Controlled Parallel-Group Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Peak Nasal Inspiratory Flow (PNIF)
研究概览
简要总结
This is a prospective study. It enrolls subjects with allergic rhinitis, with or without asthma, who have nasal congestion as the main symptom and meet the inclusion criteria, aiming to evaluate the efficacy and safety of acoustic vibration combined with an oscillating positive expiratory pressure device in the treatment of patients with nasal congestion. On the premise that subjects agree to use basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA), they are instructed to use the acoustic vibration therapy device and the oscillating positive expiratory pressure therapy device respectively, 3 times a day for 3 minutes each time. Indicators related to nasal congestion will be measured immediately after a single use, as well as at 2 weeks, 4 weeks, and 8 weeks of use, so as to monitor the improvement of nasal ventilation and accompanying symptoms in the subjects.
详细描述
Objective: To evaluate the efficacy and safety of acoustic vibration combined with an oscillating positive expiratory pressure device in the treatment of patients with nasal congestion.
Methods: A total of 200 subjects with nasal congestion as the main symptom who met the inclusion criteria were enrolled in this study. Among them, 100 subjects were treated with an acoustic vibration therapy device (treatment group), including 50 subjects with allergic rhinitis and 50 subjects with allergic rhinitis complicated with asthma; the other 100 subjects were treated with an oscillating positive expiratory pressure therapy device (without acoustic function, only with oscillating positive expiratory pressure function) as the control group, which also included 50 subjects with allergic rhinitis and 50 subjects with allergic rhinitis complicated with asthma. On the premise that subjects agreed to use basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA), they were instructed to use the acoustic vibration therapy device or the oscillating positive expiratory pressure therapy device, respectively, 3 times a day for 3 minutes each time. Nasal congestion-related indicators were measured immediately after a single use, as well as at 2 weeks, 4 weeks, and 8 weeks of use. The improvement of nasal ventilation and accompanying symptoms was monitored to clarify the efficacy and safety of the two devices.
Key Inclusion Criteria:
Subjects aged 12-50 years at the time of signing the informed consent form, regardless of gender;Meeting the guideline diagnostic criteria for allergic rhinitis with or without asthma;Presenting with significant nasal congestion for at least 1 week, with or without asthma, and symptoms poorly controlled despite the use of intranasal glucocorticoids and/or other therapeutic drugs;Patients with moderate to severe seasonal allergic rhinitis (SAR) with a mean Total Nasal Symptom Score (TNSS) ≥ 9 points, including nasal congestion ≥ 3 points;Willing and able to complete follow-up visits and scoring assessments at 2 weeks, 4 weeks, and 8 weeks during the study period as required by the protocol;Regular use of standard medications;Willing to receive treatment with acoustic vibration or oscillating positive expiratory pressure device 3 times a day for 3 minutes each time, and perform corresponding check-in and reporting;Voluntarily signing the informed consent form before the start of any study-related procedures, able to communicate smoothly with researchers, understand and be willing to strictly comply with the requirements of this clinical study protocol to complete the study.
Expected Outcomes:
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 12-50 years at the time of signing the informed consent form, regardless of gender; Meeting the guideline diagnostic criteria for allergic rhinitis with or without asthma; Presenting with significant nasal congestion for at least 1 week, with or without asthma, and symptoms poorly controlled despite the use of intranasal glucocorticoids and/or other therapeutic drugs; Patients with moderate to severe seasonal allergic rhinitis (SAR) with a mean Total Nasal Symptom Score (TNSS) ≥ 9 points, including nasal congestion ≥ 3 points; Willing and able to complete follow-up visits and scoring assessments at 2 weeks, 4 weeks, and 8 weeks during the study period as required by the protocol; Regular use of standard medications; Willing to receive treatment with acoustic vibration or oscillating positive expiratory pressure device 3 times a day for 3 minutes each time, and perform corresponding check-in and reporting; Voluntarily signing the informed consent form before the start of any study-related procedures, able to communicate smoothly with researchers, understand and be willing to strictly comply with the requirements of this clinical study protocol to complete the study.
排除标准
- •Exclusion criteria identified by pre-examination with nasal endoscopy include: definite structural/mechanical obstruction (moderate-to-severe nasal septum deviation, moderate-to-severe nasal valve collapse, grade 3-4 nasal polyps, and inferior turbinate hypertrophy that may reduce decongestion reversibility); A history of severe epistaxis within 3 months, or use of anticoagulants; Complicated with unstable asthma; Patients currently receiving special treatment regimens, including biologic therapy and dust mite desensitization therapy; Complicated with major diseases of the respiratory or cardiovascular system: such as moderate-to-severe COPD, coronary heart disease, bronchiectasis, pulmonary infection, or respiratory tract infection; Suffering from malignant tumors or having a history of malignant tumors (except for cutaneous squamous cell carcinoma, basal cell carcinoma, or cervical carcinoma in situ that have been completely resected with no evidence of recurrence); Having undergone major surgery within 3 months before randomization, or planning to undergo major surgery during the study period; Suffering from severe concomitant diseases or other conditions that, in the investigator's judgment, make the patient unsuitable for participation in this trial.
研究组 & 干预措施
treatment group 1-nasal congestion with only atopic rhinitis
this group participants use the acoustic vibration device therapy device, respectively, 3 times a day for 3 minutes each time for 2 month
干预措施: VPAT (Vibratory Positive Pressure Therapeutic Apparatus） (Device)
treatment group 1-nasal congestion with only atopic rhinitis
this group participants use the acoustic vibration device therapy device, respectively, 3 times a day for 3 minutes each time for 2 month
干预措施: basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA (Drug)
treatment group 2-nasal congestion with atopic rhinitis and atopic asthma
this group participants use the acoustic vibration device therapy device, respectively, 3 times a day for 3 minutes each time for 2 month
干预措施: VPAT (Vibratory Positive Pressure Therapeutic Apparatus） (Device)
treatment group 2-nasal congestion with atopic rhinitis and atopic asthma
this group participants use the acoustic vibration device therapy device, respectively, 3 times a day for 3 minutes each time for 2 month
干预措施: basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA (Drug)
control group 1-nasal congestion with only atopic rhinitis
this group participants use the oscillating positive expiratory pressure therapy device (without acoustic function), respectively, 3 times a day for 3 minutes each time for 2 months.
干预措施: basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA (Drug)
control group 1-nasal congestion with only atopic rhinitis
this group participants use the oscillating positive expiratory pressure therapy device (without acoustic function), respectively, 3 times a day for 3 minutes each time for 2 months.
干预措施: OPEP（Oscillating Positive Expiratory Pressure device） (Device)
control group 2-nasal congestion with atopic rhinitis and atopic ashtma
this group participants use the oscillating positive expiratory pressure therapy device (without acoustic function), respectively, 3 times a day for 3 minutes each time for 2 months.
干预措施: basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA (Drug)
control group 2-nasal congestion with atopic rhinitis and atopic ashtma
this group participants use the oscillating positive expiratory pressure therapy device (without acoustic function), respectively, 3 times a day for 3 minutes each time for 2 months.
干预措施: OPEP（Oscillating Positive Expiratory Pressure device） (Device)
结局指标
主要结局
Peak Nasal Inspiratory Flow (PNIF)
时间窗: These indicators are measured at baseline, immediately after a single use, and at 2 weeks, 4 weeks, and 8 weeks of use.
PNIF is a simple, portable inspiratory flow meter, which measures PNIF (peak nasal inspiratory flow) through the nasal passage; providing information of nasal obstruction. Objective measurement of nasal obstruction is useful in the diagnosis of a number of conditions and establishing efficacy of nasal decongestants, it can be Individually calibrated and used during assessment of allergic rhinitis.
次要结局
- FeNO (Fractional Exhaled Nitric Oxide)(These indicators are measured at baseline, immediately after a single use, and at 2 weeks, 4 weeks, and 8 weeks of use.)
- VAS (Visual Analogue Scale )(These indicators are measured at baseline, immediately after a single use, and at 2 weeks, 4 weeks, and 8 weeks of use.)
- Total Nasal Symptom Score + Total Non-Nasal Symptom Score (TNSS + TNNSS)(These indicators are measured at baseline, 2 weeks, 4 weeks, and 8 weeks of use.)
- Peak Expiratory Flow (PEF)(These indicators are measured at baseline, immediately after a single use, and at 2 weeks, 4 weeks, and 8 weeks of use.)
- RQLQ(Rhinitis-Related Quality of Life Questionnaire )(These indicators are measured at baseline, 2 weeks, 4 weeks, and 8 weeks of use.)
- ACT(Asthma Control Test )(These indicators are measured at baseline, 2 weeks, 4 weeks, and 8 weeks of use.)
- AQLQ(Asthma Quality of Life Questionnaire )(These indicators are measured at baseline, 2 weeks, 4 weeks, and 8 weeks of use.)
- anterior rhinoscope(These indicators are measured at baseline, 2 weeks, 4 weeks, and 8 weeks of use.The anterior rhinoscope is used to examine for the presence of bleeding, aggravated ulcers.)
- Pulmonary Function Test FEV1/FVC ratio(up to 8 weeks)
- Pulmonary Function Test(up to 8 weeks)