NCT07218484 VoiceLove Digital Therapy for Delirium in the ICU
| NCT ID | NCT07218484 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Methodist Hospital Research Institute |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-08-21 |
| Primary Completion | 2026-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-08-21 with a primary completion date of 2026-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 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 2. At risk of delirium, as per ICU delirium risk score or existing diagnosis 3. Family members or caregivers involved in patient care at least 18 years of age. 4. Clinical team members caring for the patients Exclusion Criteria: * Patients in the ICU who have 1. a history of severe mental illness, 2. admission for a drug overdose, 3. severe vertigo, 4. a history of severe postoperative nausea and vomiting, 5. hearing or visual impairments, 6. preexisting severe dementia (Montreal Cognitive Assessment Score \<15), 7. neurological surgeries.
Contact & Investigator
Hina Faisal, MD
PRINCIPAL INVESTIGATOR
The Methodist Hospital Research Institute
Frequently Asked Questions
Who can join the NCT07218484 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07218484 currently recruiting?
Yes, NCT07218484 is actively recruiting participants. Contact the research team at dwcleere@houstonmethodist.org for enrollment information.
Where is the NCT07218484 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07218484 clinical trial?
NCT07218484 is sponsored by The Methodist Hospital Research Institute. The principal investigator is Hina Faisal, MD at The Methodist Hospital Research Institute. The trial plans to enroll 15 participants.