VoiceLove Digital Therapy for Delirium

Overseen By Shondra Word

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Disqualifiers: Severe mental illness, Drug overdose, Severe dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 3 days

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital therapy called VoiceLove to help manage delirium, a condition causing confusion and agitation, in patients who have undergone major surgery and are in the ICU. The goal is to determine if this therapy is safe, feasible, and acceptable for use while patients remain in bed and calm. Individuals who have recently had major surgery and require an ICU stay of at least three days might find this trial suitable. The study seeks participants at risk of confusion or agitation post-surgery. As an unphased trial, it provides an opportunity to explore innovative therapy options that could enhance recovery experiences.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that VoiceLove Digital Therapy is safe for managing delirium in surgical ICU patients?

Research shows that VoiceLove Digital Therapy remains in the early stages of safety testing. Researchers are trying this therapy to help manage delirium in ICU patients. The trial is marked as "Not Applicable" for phase, indicating limited safety data from earlier studies. However, this suggests the therapy is considered safe enough for human testing.

Digital therapies like VoiceLove are non-invasive, meaning they don't involve surgery or needles, which usually results in a lower risk of side effects compared to more invasive treatments. Although specific reports of side effects for VoiceLove are absent, testing on people indicates some confidence in its safety.

In summary, while solid safety data is not yet available, VoiceLove Digital Therapy is designed as a gentle, app-based treatment. Its non-invasive nature likely means it is well-tolerated, but further studies will help confirm its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

VoiceLove Digital Therapy is unique because it uses digital technology to address delirium, a condition typically managed with medications like antipsychotics or sedatives. Unlike these drugs, which can have significant side effects, VoiceLove offers a non-invasive approach through guided sessions that aim to calm and orient patients. Researchers are excited about this treatment because it could offer a safer, more accessible alternative that provides benefits without the drawbacks of traditional medication.

What evidence suggests that VoiceLove Digital Therapy is effective for managing delirium?

Research suggests that VoiceLove Digital Therapy might help manage sudden confusion, known as delirium, in ICU patients. Delirium can cause changes in behavior and thinking. This digital therapy involves listening to calming audio sessions. Although extensive data on its effectiveness is not yet available, the therapy aims to engage patients and possibly reduce delirium episodes. It focuses on creating a soothing environment to help stabilize the patient's mind. This trial specifically evaluates how well patients can use and benefit from this therapy in hospitals. ^{1 2 3 5 6}

Who Is on the Research Team?

Hina Faisal, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for surgical ICU patients at risk of delirium. It's a small study aiming to see if VoiceLove, a digital therapy, is doable and safe. Participants should be willing to engage with the therapy for 20-25 minutes.

Inclusion Criteria

At risk of delirium, as per ICU delirium risk score or existing diagnosis

Clinical team members caring for the patients

My caregiver is at least 18 years old.

Exclusion Criteria

Patients in the ICU admitted for a drug overdose

I am in the ICU and have had severe nausea and vomiting after surgery.

Patients in the ICU with preexisting severe dementia (Montreal Cognitive Assessment Score <15)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (pre-operative)

Treatment

Participants receive VoiceLove digital therapy sessions twice daily for 3 days

3 days

3 visits (in-person)

Assessment

Participants undergo daily assessments of CAM-ICU and Richmond Agitation-Sedation Scale for 7 days

7 days

Daily assessments (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including acceptability assessment

Until hospital discharge

1 visit (in-person) at discharge

What Are the Treatments Tested in This Trial?

Interventions

• VoiceLove Digital Therapy

Trial Overview

The trial tests VoiceLove digital therapy's effectiveness in managing delirium among ICU patients. It's an initial study involving 15 people, setting the stage for future larger trials.

How Is the Trial Designed?

Group I: Patient participant Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07218484

VoiceLove Digital Therapy for Delirium in the ICU

These trials gather additional information about a drug's safety, efficacy ... As of January 1, 2020, initial results submissions for applicable ...

2.

reporter.nih.gov

reporter.nih.gov/project-details/10602709

VoiceLove

In addition, delirium accelerates cognitive decline in AD/ADRD patients. Likewise, patients with underlying dementia are 2.5-4.7 times more likely to develop ...

3.

withpower.com

withpower.com/trial/phase-confusion-7-2025-50763

VoiceLove Digital Therapy for Delirium

The study expects that 70% of participants will complete 20 -25 minutes of the VoiceLOVE digital therapy. Descriptive statistics will be used to ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06923462

Study Details | NCT06923462 | VoiceLove: An App-Based ...

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical ...

5.

nia.nih.gov

nia.nih.gov/research/sbir/nia-small-business-showcase/voicelove

NIA Small Business Showcase: VoiceLove

VoiceLove will need a $2.5 million Phase II grant from NIA to run an RCT to evaluate the effectiveness of the app to combat delirium. It will ...

6.

meddatax.com

meddatax.com/clinical-trials/NCT07218484

VoiceLove Digital Therapy for Delirium in the ICU

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 ...