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

NCT07114107 | Not Yet Recruiting

• 1 other identifier: 2025-0820
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Rhinitis; Atopic Asthma

Keywords

nasal congestion; Vibroacoustic therapy; Oscillating Positive Expiratory Pressure

Outcome Measures

Primary Outcomes (1)

• Peak Nasal Inspiratory Flow (PNIF)

  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.

  These indicators are measured at baseline, immediately after a single use, and at 2 weeks, 4 weeks, and 8 weeks of use.

Secondary Outcomes (10)

• 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.

• 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.

• RQLQ(Rhinitis-Related Quality of Life Questionnaire )

  These indicators are measured at baseline, 2 weeks, 4 weeks, and 8 weeks of use.

• 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.

Study Arms (4)

treatment group 1-nasal congestion with only atopic rhinitis

EXPERIMENTAL

this group participants use the acoustic vibration device therapy device, respectively, 3 times a day for 3 minutes each time for 2 month

Device: VPAT (Vibratory Positive Pressure Therapeutic Apparatus）; Drug: basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA

treatment group 2-nasal congestion with atopic rhinitis and atopic asthma

EXPERIMENTAL

this group participants use the acoustic vibration device therapy device, respectively, 3 times a day for 3 minutes each time for 2 month

Device: VPAT (Vibratory Positive Pressure Therapeutic Apparatus）; Drug: basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA

control group 1-nasal congestion with only atopic rhinitis

ACTIVE COMPARATOR

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.

Drug: basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA; Device: OPEP（Oscillating Positive Expiratory Pressure device）

control group 2-nasal congestion with atopic rhinitis and atopic ashtma

ACTIVE COMPARATOR

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.

Drug: basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA; Device: OPEP（Oscillating Positive Expiratory Pressure device）

Interventions

VPAT (Vibratory Positive Pressure Therapeutic Apparatus） 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.

treatment group 1-nasal congestion with only atopic rhinitis; treatment group 2-nasal congestion with atopic rhinitis and atopic asthma

basic medications (antihistamines, mometasone furoate nasal spray, ICS-LABA 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; control group 2-nasal congestion with atopic rhinitis and atopic ashtma; treatment group 1-nasal congestion with only atopic rhinitis; treatment group 2-nasal congestion with atopic rhinitis and atopic asthma

OPEP（Oscillating Positive Expiratory Pressure device） 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 1-nasal congestion with only atopic rhinitis; control group 2-nasal congestion with atopic rhinitis and atopic ashtma

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Huzhou Central Hospital: collaborator
• The Children's Hospital of Zhejiang University School of Medicine: collaborator
• First People's Hospital of Hangzhou: collaborator

Study Sites (1)

Huiying Wang

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Nasal Obstruction

Interventions

Histamine Antagonists

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders

Intervention Hierarchy (Ancestors)

Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Huiying Wang

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

  STUDY DIRECTOR

Central Study Contacts

Huiying Wang, Doctor(PhD,MD)

CONTACT

86(0571)-87783627; marywang@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Randomized, double-Blind, Multi-Center，Placebo-Controlled Parallel-Group Clinical Trial

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 11, 2025
• Study Start: August 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)