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NCT Number: NCT07218484

VoiceLove Digital Therapy for Delirium in the ICU

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Darrel Cleere, BSN RN CCRP

CONTACT

[email protected]

713-441-6232

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of VoiceLove digital therapy use by participants in the ICU

    Time frame: Baseline to day 3

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

Secondary outcomes

  1. 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.

    Mean change in SpO2 during VoiceLove digital therapy sessions

  2. 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.

    Mean change in blood pressure during VoiceLove digital therapy sessions

  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.

    Mean change in respiratory rate during VoiceLove digital therapy sessions

  4. 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.

    Mean change in heart rate during VoiceLove digital therapy sessions

Other outcomes

  1. Acceptability of VoiceLove digital therapy

    Time frame: Day of Hospital Discharge, Visit 8

    Proportion of participants with a system usability scale score >35

  2. Delirium onset during the study

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

    Proportion of participants with delirium onset

  3. Hypoactive delirium

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

    Proportion of participants with hypoactive delirium

  4. Hyperactive delirium

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

    Proportion of participants with hyperactive delirium

  5. Delirium severity

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

    Proportion of participants with mild, moderate, or severe delirium

  6. Delirium days

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

    Total number of delirium-positive days

  7. Readmissions to the ICU during the hospital stay

    Time frame: From last day in ICU to a return to ICU prior to hospital discharge, Visit 8

    Total number of readmissions to the ICU

  8. Family satisfaction survey

    Time frame: ICU day 3, Visit 4

    Total score of system usability survey for family or caregiver member

Study contacts

Contact information is provided by the study sponsor or research team.

Darrel Cleere, BSN RN CCRP

CONTACT

[email protected]

713-441-6232

Shondra Word

CONTACT

[email protected]

713-441-5122

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 20, 2025
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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