VoiceLove Digital Therapy for Delirium in the ICU
Recruiting now · Not applicable
Conditions studied: Delirium
In brief
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.
Key facts
- Study ID
- NCT07218484
- Run by
- The Methodist Hospital Research Institute
- People needed
- 15
- Starts
- 2025-08-21
- Expected to finish
- 2026-01-31
- Last updated by the study team
- 2025-10-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Houston Methodist Hospital — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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