DeliriumNCT07218484
VoiceLove Digital Therapy for Delirium in the ICU
A study testing VoiceLove therapy in people with Delirium, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- VoiceLove therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Darrel Cleere, BSN RN CCRP, 713-441-6232, dwcleere@houstonmethodist.org
About this study
Official title: Feasibility of VoiceLove Digital Therapy for Delirium Management in ICU Patients: A Pilot Study
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.
Read the 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.
- Conditions
- Delirium
- Being tested
- VoiceLove therapy
- Keywords
- delirium, intensive care unit, cognitive dysfunction, confusion
- Medical subject headings
- Delirium, Cognitive Dysfunction, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoiceLove therapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| Patient participant | Experimental | 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. Receives: Behavioral: VoiceLove therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of VoiceLove digital therapy use by participants in the ICU
70% of participants complete two 25-minute sessions of VoiceLove digital therapy per day for 3 days
Measured: Baseline to day 3
Secondary outcomes (4)
Change in peripheral arterial oxygen saturation (SpO2) after VoiceLove digital therapy
Mean change in SpO2 during VoiceLove digital therapy sessions
Measured: 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
Mean change in blood pressure during VoiceLove digital therapy sessions
Measured: 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
Mean change in respiratory rate during VoiceLove digital therapy sessions
Measured: 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
Mean change in heart rate during VoiceLove digital therapy sessions
Measured: Start of VoiceLove digital therapy to 25 minutes of session on day 1, on day 2, and on day 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start21 Aug 2025
- Primary completion15 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a single-center, single-arm, prospective trial
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hina Faisal, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218484
- Sponsor's protocol ID
- PRO00041572
- Status last verified
- Oct 2025
- First submitted
- 28 Aug 2025
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study does not allow release of individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of VoiceLove Digital Therapy for Delirium Management in ICU Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT07218484
- Acronym / sponsor ID
- PRO00041572
- Conditions
- Delirium
- Keywords
- delirium, intensive care unit, cognitive dysfunction, confusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a single-center, single-arm, prospective trial
| Arm | Type | Receives |
|---|---|---|
| Patient participant | Experimental | Behavioral: VoiceLove therapyTwo 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Patients in the ICU who have
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VoiceLove therapyVoiceLove 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. | Behavioural | Patient participant |
Primary outcome
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
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Individual participant dataSharing planned: No. The study does not allow release of individual participant data
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
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DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hina Faisal, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VoiceLove therapy in people with Delirium, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darrel Cleere, BSN RN CCRP (713-441-6232, dwcleere@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of VoiceLove digital therapy use by participants in the ICU (time frame: Baseline to day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.