Who is eligible for clinical trial NCT07218484?

Participants must meet protocol criteria for Delirium. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07218484 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-10-16

VoiceLove Digital Therapy for Delirium in the ICU (NCT07218484)

🟢 Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: The Methodist Hospital Research Institute

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (9 items).

Location: Houston Methodist Hospital — Houston, Texas

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Men and women aged ≥18 years admitted to the hospital after major surgery (elective or non-elective) require a hospital stay of at least five days following surgery, including an ICU stay for at least three days after the surgical procedure
At risk of delirium, as per ICU delirium risk score or existing diagnosis
Family members or caregivers involved in patient care at least 18 years of age.
Clinical team members caring for the patients

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Patients in the ICU who have
a history of severe mental illness,
admission for a drug overdose,
severe vertigo,
a history of severe postoperative nausea and vomiting,
hearing or visual impairments,
preexisting severe dementia (Montreal Cognitive Assessment Score \<15),
neurological surgeries.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Houston Methodist Hospital — Houston, Texas

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗