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

A Two-center, Randomized, Controlled Trial Investigating a Newly-developed Neuromodulation Auditory System Using Binaural Beats to Optimize Patient Experience During Dysfunctional Dialysis Access Endovascular Procedures

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07467642

Enrollment

100

Registered

2026-03-12

Start date

2024-12-01

Completion date

2026-03-30

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dialysis Access Dysfunction, Endovascular Procedure, Neuromodulation, Patient Experience

Keywords

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

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.

Detailed description

Following an extensive development phase, a two-center RCT will be conducted at two Interventional Radiology Departments of tertiary university hospitals. Patients fulfilling the study's inclusion criteria will be randomized on a 1:1 basis to undergo endovascular procedures for dysfunctional dialysis vascular access-performed under local anaesthesia without sedation-either with the audio system (Group Sound; S) or without it (Group Control; C). The intervention is utilizing an MP3 audio system and headphones delivering binaural beats, isochronic tones, and music designed to induce relaxation by achieving the alpha brainwave state (8-12Hz). Patient experience will be evaluated via standardized self-reported questionnaires. Patient's demographical data and procedural details will be recorded.

Interventions

DEVICENeuromodulation auditory system

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Overall patient experience	Within the first hour after the procedure	Completion of a standardized self-reported Stress-orientated questionnaire, with higher values indicating worst outcome.

Countries

Greece

Contacts

PRINCIPAL_INVESTIGATORStavros Spiliopoulos, MD, PhD

ATTIKO University General Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026