NCT07218484

VoiceLove Digital Therapy for Delirium in the ICU

Feasibility of VoiceLove Digital Therapy for Delirium Management in ICU Patients: A Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

VoiceLove digital therapy includes voice recordings of the participant's loved one delivered at the bedside via a smartphone attached to the bed. The VoiceLove digital therapy will be delivered in the morning and in the evening and will play for 20-25 minutes each session. Participants will have a pre-operative visit, 3 consecutive intervention visits with vital signs assessment, 7 days of assessments of Confusion Assessment Methods (CAM)-ICU (morning and evening), and 7 days of a Richmond Agitation-Sedation Scale assessment. The participant will provide an assessment of the acceptability of the VoiceLove digital therapy using a system usability scale score at the end of their participation in the study.

Conditions

• Delirium

Interventions

Type	Name	Description
BEHAVIORAL	VoiceLove therapy	VoiceLove digital interventions represent voice recordings, specifically, (i) Reorientation messages, and (ii) general communication domain calming and encouraging voice messages recorded in familiar voices from family and friends. Families will be guided to record and deliver Reorientation messages, that can be played to the patient.

Timeline

• Start date: 2025-08-21
• Primary completion: 2026-01-15
• Completion: 2026-01-31
• First posted: 2025-10-20
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States