A Neuromodulation Auditory System to Optimize Patient Experience During Dysfunctional Dialysis Access Endovascular Procedures

NCT07467642 | Active Not Recruiting

• 1 other identifier: 122730/15-11-2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Peri-procedural stress is a common challenge in interventional radiology that can negatively impact patient tolerance and the overall procedural experience. This randomized controlled trial (RCT) was designed to evaluate the clinical impact of a non-commercially available, newly-developed structured auditory neuromodulation system, designed to optimize patient experience during endovascular procedures for dysfunctional dialysis access.

Conditions

Dialysis Access Dysfunction; Endovascular Procedure; Patient Experience; Neuromodulation

Keywords

Balloon angioplasty; Dialysis access; Dysfunctional dialysis access; Stent graft; Autologous arteriovenous fistula; Dialysis arteriovenous graft; Neuromodulation; Binaural beats

Outcome Measures

Primary Outcomes (1)

• Overall patient experience

  Completion of a standardized self-reported Stress-orientated questionnaire, with higher values indicating worst outcome.

  Within the first hour after the procedure

Study Arms (2)

Group Sound

ACTIVE COMPARATOR

Patients randomized to undergo the procedure with the audio system

Device: Neuromodulation auditory system

Group Control

NO INTERVENTION

Patients randomized to undergo the procedure without the audio system

Interventions

Neuromodulation auditory system DEVICE

An MP3 audio system delivering via headphones, binaural beats, isochronic tones, and music designed to induce relaxation by achieving the alpha brainwave state (8-12Hz).

Group Sound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dysfunctional vascular access (AVF or AVG) requiring endovascular treatment.
• Balloon Angioplasty procedure
• Stent graft procedure
• Percutaneous declotting procedure

You may not qualify if:

• Demenzia
• Patient not tolerating headphones or music for any reason
• Patients less than 18 years old
• Patients unable to comprehend and complete the questionnaire

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (2)

"ATTIKON" University General Hospital, , 1st Rimini St,

Athens, Select A State, 12461, Greece

Location

Patras University Hospital

Pátrai, Greece

Location

Study Officials

• Stavros Spiliopoulos, MD, PhD

  ATTIKO University General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Diagnostic and Interventional Radiology

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: December 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication

Locations

GR (2)