VoiceLove Digital Therapy for Delirium in the ICU

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT07218484
Status
Recruiting
Apply to this trial

Conditions

  • Delirium

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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 Dates

Start date
Aug 21, 2025
Status verified
Oct 2025
Primary completion
Jan 15, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Patient participant
    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.

Primary Outcome Measure

Feasibility of VoiceLove digital therapy use by participants in the ICU [ Time Frame: Baseline to day 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030
Darrel Cleere, BSN RN CCRP
[email protected]
713-441-6232

Find similar trials in Houston, TX

By research site
Houston Methodist Hospital· Houston, TX

Related Studies