VoiceLove Digital Therapy for Delirium in the ICU

NCT07218484 | Recruiting

• 1 other identifier: PRO00041572
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

delirium; intensive care unit; cognitive dysfunction; confusion

Outcome Measures

Primary Outcomes (1)

• Feasibility of VoiceLove digital therapy use by participants in the ICU

  70% of participants complete two 25-minute sessions of VoiceLove digital therapy per day for 3 days

  Baseline to day 3

Secondary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Other Outcomes (8)

• Acceptability of VoiceLove digital therapy

  Day of Hospital Discharge, Visit 8

• Delirium onset during the study

  From start of VoiceLove digital therapy sessions at baseline through study completion, day 7

• Hypoactive delirium

  From start of VoiceLove digital therapy sessions at baseline through study completion, day 7

Study Arms (1)

Patient participant

EXPERIMENTAL

Two sessions per day of VoiceLove digital therapy will be administered with each session lasting 20-25 minutes. Sessions will occur during days 1-3 while the participant is in bed and in an alert and calm state.

Behavioral: VoiceLove therapy

Interventions

VoiceLove therapy BEHAVIORAL

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.

Patient participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction; Confusion

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Hina Faisal, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darrel Cleere, BSN RN CCRP

CONTACT

713-441-6232; dwcleere@houstonmethodist.org

Shondra Word

CONTACT

713-441-5122; sword@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a single-center, single-arm, prospective trial

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: October 20, 2025
• Study Start: August 21, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 31, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)