VoiceLove Digital Therapy for Delirium in the ICU
Key facts
- Who runs it
- The Methodist Hospital Research Institute
- Where
- Houston, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 15 people, planned
- Started
- 21 Aug 2025
- Planned end
- 31 Jan 2026
- Type of study
- Interventional
- Treatments tested
- VoiceLove therapy
- Record updated
- 20 October 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 in United States
- Houston Methodist HospitalHouston, United StatesContact: Darrel Cleere, BSN RN CCRPTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- Patient participantTreatment being tested
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.
Treatment: VoiceLove therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Feasibility of VoiceLove Digital Therapy for Delirium Management in ICU Patients: A Pilot Study
- Record updated
- 20 October 2025