Vibroacoustic Therapy With Oscillating Positive Expiratory Pressure in the Treatment of Nasal Congestion

NCT ID: NCT07114107

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-05-31

Brief Summary

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.

Detailed Description

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:

Statistically significant improvements in relevant parameters in the oscillating positive expiratory pressure therapy device group after treatment, including: Peak Nasal Inspiratory Flow (PNIF), Peak Expiratory Flow (PEF), Fractional Exhaled Nitric Oxide(FeNO), Visual Analogue Scale (VAS), Total Nasal Symptom Score + Total Non-Nasal Symptom Score (TNSS + TNNSS), Rhinitis-Related Quality of Life Questionnaire (RQLQ), Asthma Control Test (ACT), Asthma Quality of Life Questionnaire (AQLQ), anterior rhinoscope (ENT), Pulmonary Function Tests, etc. The safety of acoustic vibration therapy device and oscillating positive expiratory pressure therapy device in the treatment of nasal congestion will be clarified, specifically including the incidence of adverse events such as no epistaxis, dyspnea, etc.

Hypothesis:

In the treatment of subjects with nasal congestion as the main symptom, whether they have simple allergic rhinitis or allergic rhinitis complicated with asthma, nasal congestion and related symptoms are significantly improved after daily treatment with acoustic vibration or oscillating positive expiratory pressure devices 3 times a day.

Conditions

Atopic Rhinitis; Atopic Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

VPAT (Vibratory Positive Pressure Therapeutic Apparatus）

Intervention Type: DEVICE

VPAT (Vibratory Positive Pressure Therapeutic Apparatus）is a physical solution which can relieve nasal congestion and discomforts by applying acoustic vibration and oscillatory positive expiratory pressure. Clinical research has shown that low-frequency vibration at approximately 130 Hz promotes the production of the highest concentration of Nitric Oxide (NO) in the paranal sinuses, which helps to regulate the nasal mucosal blood, restoring the mucous membrance-cilia mechanism, clean up the bacteria, viruses and allergenic particles in the respiratory tract.

Combined with Oscillatory Positive Expiratory Pressure and Transnasal Breathing, it can help to cultivate the habit of nasal breathing and slow breathing, as well as to restore the function of lungs.

basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA

Intervention Type: DRUG

All participants need basic control drugs contains antihistamines(Ebastine 10 mg once daily for 2 weeks), mometasone furoate nasal spray(Spray 2 puffs into each nostril, each puff contains 50 μg of mometasone furoate, i.e., 100 μg per administration, once daily for 2 weeks).

Asthma participants should added Inhaled corticosteroids-long-acting beta-agonists (ICS-LABA) therapy. For mild to moderate asthma: budesonide/formoterol (160μg/4.5μg) , with 1 inhalation each time, twice daily, or salmeterol/fluticasone propionate (50μg/100μg) with 1 inhalation each time, twice daily. For moderate to severe asthma: Budesonide/Formoterol (320μg/4.5μg), with 1 inhalation each time, twice daily; or salmeterol/fluticasone propionate (50μg/250μg or 50μg/500μg) with 1 inhalation each time, twice daily. Dosage adjustments should be evaluated and determined by the physician based on the patient's disease control status.

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

Group Type: EXPERIMENTAL

VPAT (Vibratory Positive Pressure Therapeutic Apparatus）

Intervention Type: DEVICE

VPAT (Vibratory Positive Pressure Therapeutic Apparatus）is a physical solution which can relieve nasal congestion and discomforts by applying acoustic vibration and oscillatory positive expiratory pressure. Clinical research has shown that low-frequency vibration at approximately 130 Hz promotes the production of the highest concentration of Nitric Oxide (NO) in the paranal sinuses, which helps to regulate the nasal mucosal blood, restoring the mucous membrance-cilia mechanism, clean up the bacteria, viruses and allergenic particles in the respiratory tract.

Combined with Oscillatory Positive Expiratory Pressure and Transnasal Breathing, it can help to cultivate the habit of nasal breathing and slow breathing, as well as to restore the function of lungs.

basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA

Intervention Type: DRUG

All participants need basic control drugs contains antihistamines(Ebastine 10 mg once daily for 2 weeks), mometasone furoate nasal spray(Spray 2 puffs into each nostril, each puff contains 50 μg of mometasone furoate, i.e., 100 μg per administration, once daily for 2 weeks).

Asthma participants should added Inhaled corticosteroids-long-acting beta-agonists (ICS-LABA) therapy. For mild to moderate asthma: budesonide/formoterol (160μg/4.5μg) , with 1 inhalation each time, twice daily, or salmeterol/fluticasone propionate (50μg/100μg) with 1 inhalation each time, twice daily. For moderate to severe asthma: Budesonide/Formoterol (320μg/4.5μg), with 1 inhalation each time, twice daily; or salmeterol/fluticasone propionate (50μg/250μg or 50μg/500μg) with 1 inhalation each time, twice daily. Dosage adjustments should be evaluated and determined by the physician based on the patient's disease control status.

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.

Group Type: ACTIVE_COMPARATOR

basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA

Intervention Type: DRUG

All participants need basic control drugs contains antihistamines(Ebastine 10 mg once daily for 2 weeks), mometasone furoate nasal spray(Spray 2 puffs into each nostril, each puff contains 50 μg of mometasone furoate, i.e., 100 μg per administration, once daily for 2 weeks).

Asthma participants should added Inhaled corticosteroids-long-acting beta-agonists (ICS-LABA) therapy. For mild to moderate asthma: budesonide/formoterol (160μg/4.5μg) , with 1 inhalation each time, twice daily, or salmeterol/fluticasone propionate (50μg/100μg) with 1 inhalation each time, twice daily. For moderate to severe asthma: Budesonide/Formoterol (320μg/4.5μg), with 1 inhalation each time, twice daily; or salmeterol/fluticasone propionate (50μg/250μg or 50μg/500μg) with 1 inhalation each time, twice daily. Dosage adjustments should be evaluated and determined by the physician based on the patient's disease control status.

OPEP（Oscillating Positive Expiratory Pressure device）

Intervention Type: DEVICE

Oscillating Positive Expiratory Pressure (OPEP) device contain a inner ball that creates a resistance and oscillates when the patient blows through the device. This resistance helps splint the airways open during exhalation whilst the oscillation loosens the mucous within the airways. This makes it easier for some patients to clear their sputum.

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.

Group Type: ACTIVE_COMPARATOR

basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA

Intervention Type: DRUG

All participants need basic control drugs contains antihistamines(Ebastine 10 mg once daily for 2 weeks), mometasone furoate nasal spray(Spray 2 puffs into each nostril, each puff contains 50 μg of mometasone furoate, i.e., 100 μg per administration, once daily for 2 weeks).

Asthma participants should added Inhaled corticosteroids-long-acting beta-agonists (ICS-LABA) therapy. For mild to moderate asthma: budesonide/formoterol (160μg/4.5μg) , with 1 inhalation each time, twice daily, or salmeterol/fluticasone propionate (50μg/100μg) with 1 inhalation each time, twice daily. For moderate to severe asthma: Budesonide/Formoterol (320μg/4.5μg), with 1 inhalation each time, twice daily; or salmeterol/fluticasone propionate (50μg/250μg or 50μg/500μg) with 1 inhalation each time, twice daily. Dosage adjustments should be evaluated and determined by the physician based on the patient's disease control status.

OPEP（Oscillating Positive Expiratory Pressure device）

Intervention Type: DEVICE

Oscillating Positive Expiratory Pressure (OPEP) device contain a inner ball that creates a resistance and oscillates when the patient blows through the device. This resistance helps splint the airways open during exhalation whilst the oscillation loosens the mucous within the airways. This makes it easier for some patients to clear their sputum.

Interventions

VPAT (Vibratory Positive Pressure Therapeutic Apparatus）

VPAT (Vibratory Positive Pressure Therapeutic Apparatus）is a physical solution which can relieve nasal congestion and discomforts by applying acoustic vibration and oscillatory positive expiratory pressure. Clinical research has shown that low-frequency vibration at approximately 130 Hz promotes the production of the highest concentration of Nitric Oxide (NO) in the paranal sinuses, which helps to regulate the nasal mucosal blood, restoring the mucous membrance-cilia mechanism, clean up the bacteria, viruses and allergenic particles in the respiratory tract.

Combined with Oscillatory Positive Expiratory Pressure and Transnasal Breathing, it can help to cultivate the habit of nasal breathing and slow breathing, as well as to restore the function of lungs.

Intervention Type: DEVICE

basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA

All participants need basic control drugs contains antihistamines(Ebastine 10 mg once daily for 2 weeks), mometasone furoate nasal spray(Spray 2 puffs into each nostril, each puff contains 50 μg of mometasone furoate, i.e., 100 μg per administration, once daily for 2 weeks).

Asthma participants should added Inhaled corticosteroids-long-acting beta-agonists (ICS-LABA) therapy. For mild to moderate asthma: budesonide/formoterol (160μg/4.5μg) , with 1 inhalation each time, twice daily, or salmeterol/fluticasone propionate (50μg/100μg) with 1 inhalation each time, twice daily. For moderate to severe asthma: Budesonide/Formoterol (320μg/4.5μg), with 1 inhalation each time, twice daily; or salmeterol/fluticasone propionate (50μg/250μg or 50μg/500μg) with 1 inhalation each time, twice daily. Dosage adjustments should be evaluated and determined by the physician based on the patient's disease control status.

Intervention Type: DRUG

OPEP（Oscillating Positive Expiratory Pressure device）

Oscillating Positive Expiratory Pressure (OPEP) device contain a inner ball that creates a resistance and oscillates when the patient blows through the device. This resistance helps splint the airways open during exhalation whilst the oscillation loosens the mucous within the airways. This makes it easier for some patients to clear their sputum.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huzhou Central Hospital

OTHER

Sponsor Role: collaborator

The Children's Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huiying Wang

Role: STUDY_DIRECTOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

Huiying Wang

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Huiying Wang, Doctor(PhD,MD)

Role: CONTACT

marywang@zju.edu.cn

86(0571)-87783627

Facility Contacts

Huiying Wang, PhD,MD

Role: primary

marywang@zju.edu.cn

86(0571)-87783627

Other Identifiers

2025-0820

Identifier Type: -

Identifier Source: org_study_id