VoiceLove Digital Therapy for Delirium in the ICU

Not Applicable

Recruiting

• Conditions: Delirium

• Registration Number: NCT07218484
• Lead Sponsor: The Methodist Hospital Research Institute

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.

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.

Study Timeline

• Study Start: 2025-08-21
• Study First Submitted: 2025-08-28
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-16
• Last Update Submitted: 2025-10-16
• Study First Posted: 2025-10-20
• Last Update Posted: 2025-10-20
• Primary Completion: 2026-01-15
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of VoiceLove digital therapy use by participants in the ICU	Baseline to day 3	70% of participants complete two 25-minute sessions of VoiceLove digital therapy per day for 3 days

Secondary Outcome Measures

Name	Time	Method
Change in peripheral arterial oxygen saturation (SpO2) after VoiceLove digital therapy	Start of VoiceLove digital therapy to 25 minutes of session on day 1, on day 2, and on day 3.	Mean change in SpO2 during VoiceLove digital therapy sessions
Change in blood pressure after VoiceLove digital therapy	Start of Voice Love digital therapy to 25 minutes of session on day 1, on day 2, and on day 3.	Mean change in blood pressure during VoiceLove digital therapy sessions
Change in respiratory rate after VoiceLove digital therapy	Start of VoiceLove digital therapy to 25 minutes of session on day 1, on day 2, and on day 3.	Mean change in respiratory rate during VoiceLove digital therapy sessions
Change in heart rate after VoiceLove digital therapy	Start of VoiceLove digital therapy to 25 minutes of session on day 1, on day 2, and on day 3.	Mean change in heart rate during VoiceLove digital therapy sessions

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States