Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07218484

VoiceLove Digital Therapy for Delirium in the ICU

Led by The Methodist Hospital Research Institute · Updated on 2025-10-20

15

Participants Needed

1

Research Sites

23 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study is a single-center, single-arm, prospective trial to evaluate the feasibility, safety, and acceptability of VoiceLOVE digital therapy for the management of delirium in surgical ICU patients. 15 participants will be enrolled. The study expects that 70% of participants will complete 20 -25 minutes of the VoiceLOVE digital therapy. Descriptive statistics will be used to summarize the findings. The intent is that this study will provide information for a larger, subsequent clinical trial of surgical ICU patients who are at risk for delirium.

CONDITIONS

Official Title

VoiceLove Digital Therapy for Delirium in the ICU

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 18 years or older admitted after major surgery
  • Expected hospital stay of at least five days including at least three days in ICU
  • At risk of delirium based on ICU delirium risk score or existing diagnosis
  • Family members or caregivers involved in care are at least 18 years old
  • Clinical team members caring for the patients
Not Eligible

You will not qualify if you...

  • History of severe mental illness
  • Admission for drug overdose
  • Severe vertigo
  • History of severe postoperative nausea and vomiting
  • Hearing or visual impairments
  • Preexisting severe dementia (Montreal Cognitive Assessment Score less than 15)
  • History of neurological surgeries

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Houston Methodist Hospital

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

D

Darrel Cleere, BSN RN CCRP

CONTACT

S

Shondra Word

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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