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Recruiting NCT07218484

VoiceLove Digital Therapy for Delirium in the ICU

No phase Interventional Delirium

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VoiceLove therapy.
Who it may be relevant to
Registry conditions: Delirium. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Feasibility of VoiceLove Digital Therapy for Delirium Management in ICU Patients: A Pilot Study

Overview

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.

Interventions

  • Behavioral VoiceLove therapy
    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.

Primary outcome measures

  • Feasibility of VoiceLove digital therapy use by participants in the ICU [Time frame: Baseline to day 3]
Secondary outcome measures (4)
  • Change in peripheral arterial oxygen saturation (SpO2) after VoiceLove digital therapy [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Start of VoiceLove digital therapy to 25 minutes of session on day 1, on day 2, and on day 3.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Houston Methodist Hospital — Houston

Identifiers

NCT: NCT07218484 · PRO00041572

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗