Dolores One: Maximizing Functional Communication for Adults
Public ClinicalTrials.gov record NCT03934619. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Dolores One: Maximizing Functional Communication for Adults Using Non-Invasive Ventilation in the Acute Care Setting
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Difficulties with communication for patients requiring mechanical ventilation is known to be a source of distress in the acute care setting. The inability to speak has been associated with increased psychological distress and increased feelings of fear and anger and impact negatively on patient participation with caregivers and their overall recovery. Developing and maintaining communication between patients and hospital staff reduces patient stress and increases patient satisfaction and part of the standard pf care. According to the new and revised The Joint Commission standards, hospitals must identify and document patients' communication needs and communicate with patients during their care in a manner that meets those needs. Using the Dolores One device for patients can improve the ease and efficiency of communication while they are in the acute care setting. For non-speaking patients, nonverbal communication means are often used, including mouthing words and head nods to indicate yes/no responses. However, relying completely on nonverbal means can limit patient responses and lead to ineffective and frustrating communication exchanges. There have been several studies reviewing the negative effects of the inability to speak for intubated, mechanically ventilated patients. However, there is a need for more research to address communication difficulties in other mechanically ventilated populations, including patients receiving non-invasive ventilation and ventilator dependent tracheostomy patients. The Dolores One is comprised of an acoustic throat sensor and positioned at the patient's neck with a soft adjustable collar. The sensor gathers vocal cord vibrations and transmits signals to a control unit, processes the sensor signal, and finally, generates the patient's voice. The smart signal processing automatically accommodates both weak forced voices and whispers, producing a voice output to allow for normal conversation in a patient's natural voice, free from the sounds of rushing air or equipment noises secondary to Non-Invasive Mechanical Ventilation (NIMV) systems. The purpose of the study is to determine if the Dolores One devices can be used in the clinical acute care setting with patients in NIMV to improve their ability to communication as measured as ease to communicate and intelligibility, with family and the members of the medical team.
Study identification
- NCT ID
- NCT03934619
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 6, 2019
- Primary completion
- Mar 30, 2020
- Completion
- Mar 30, 2020
- Last update posted
- Apr 14, 2022
2019 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03934619, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 14, 2022 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03934619 live on ClinicalTrials.gov.