NCT07517497

Brief Summary

A medical professional trained in the procedure and use of the device will conduct the vibroacoustic therapy session. He will also take blood samples. In the control group, patients will undergo vibroacoustic pulmonary therapy in the "Pneumonia" mode, and in the control group, in the "Prevention" mode. Vibroacoustic pulmonary therapy will be conducted over a period of 5 days. A similar algorithm of actions is planned for both groups. VALT sessions will be conducted 4-6 times a day for 5 minutes in combination with treatment according to the protocol for the use of "Vibroacoustic Therapy" of the lungs of the Ministry of Health of the Republic of Kazakhstan. The device's emitters will be applied to the affected areas of the lungs. Since the device has long cords for the emitters and is portable, it is not difficult to change the patient's position and does not require their active participation, which is important for patients on ventilators and with limited mobility.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
18mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Mar 2025Dec 2027

Study Start

First participant enrolled

March 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 8, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

November 15, 2025

Last Update Submit

April 2, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Arterial blood gases

    On day 1 of vibroacoustic therapy, arterial blood sampling will be performed to determine PaO2 (mmHg), PaC02 (mmHg), as well as for dynamics during transfer to the specialized department.

    Day 1

Secondary Outcomes (1)

  • Chest X-ray

    Day 1

Study Arms (2)

patients will undergo Vibrolung in the "Pneumonia" mode.

OTHER

vibroacoustic physiotherapy

Device: Vibrolung

patients will undergo vibroacoustic pulmonary therapy in the "Prevention" mode.

OTHER

vibroacoustic physiotherapy

Device: Vibrolung

Interventions

VibrolungDEVICE

BARK VibroLUNG vibroacoustic device (No. RK-MT-7No.013611 dated October 7, 2014). The device is designed for the treatment and prevention of respiratory diseases. The device operates on the principle of exposure to a powerful vibroacoustic signal generated by special emitters. During the procedure, the emitters are pressed against the surface of the chest, and the procedure lasts an average of 5 minutes. The frequency of the signal constantly changes and has complex modulation, which ensures maximum effectiveness. Depending on the selected program, the signal can cause the effect of percussion, soft vibration, smooth alternation of acoustic signal and vibration, or combinations thereof.

patients will undergo Vibrolung in the "Pneumonia" mode.patients will undergo vibroacoustic pulmonary therapy in the "Prevention" mode.

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • All contraindications for use of the device:
  • terminal condition of the patient;
  • shock;
  • paradoxical pathological breathing;
  • hypertensive crisis;
  • severe hypocoagulation with a risk of hematoma formation or bleeding in the projection of exposure;
  • severe hypercoagulation, risk of thrombus/embolus migration along the main vessels in the area of exposure;
  • acute cerebrovascular accident in the first 1-3 days;
  • brain edema;
  • presence of multiple purulent or burn wound surfaces in the area of exposure;
  • presence of unstable rib fractures;
  • pneumomediastinum and/or subcutaneous emphysema of the chest;
  • osteomyelitis of the ribs and/or thoracic spine;
  • spinal fracture without orthopedic fixation;
  • chest or abdominal trauma with bleeding;
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Astana medical university

Astana, 010000, Kazakhstan

RECRUITING

Central Study Contacts

Assema Bekniyazova

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The device generates electrical signals that are converted into high-intensity acoustic waves by two vibroacoustic emitters. The emitters are applied to the surface of the chest, and the sound waves propagate to the lungs, causing vibrations in the structures of the lung parenchyma. The frequency of the exposure signal constantly changes, which provides a number of effects, including the resonance effect.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Main Researcher

Study Record Dates

First Submitted

November 15, 2025

First Posted

April 8, 2026

Study Start

March 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 8, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations