NCT06568107 Environmental and Sensory Intervention for Nursing Home Residents With Dementia Who Exhibit Persistent Vocalizations
| NCT ID | NCT06568107 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Drexel University |
| Condition | Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2024-10-31 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2024-10-31 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to test a person-centered, nature-based non-pharmacological intervention for nursing home residents living with dementia who exhibit persistent vocalizations. The Environmental And Sensory Experience (EASE) involves the projection of a still nature image and the playing of nature sounds. Family members of the person living with dementia provide consent for the resident to participate in the study and complete a brief survey on nature preferences on the resident's behalf. The survey informs the research team on what nature scene to show. Participants will wear a watch that measures stress levels and research staff will monitor vocalization patterns. We will also recruit persons living with dementia from other settings such as assisted living, personal care units, and adult day care settings.
Eligibility Criteria
Inclusion Criteria: * The participants must: 1) have a medical diagnosis of dementia; 2) have severe dementia as determined by a MMSE score of ≤9 (or another cognitive test indicating severe dementia); 3) have a history of PVs per staff report; 4) be 50 years older or greater; 5) require extensive assistance by staff to ambulate or is non-ambulatory (to allow for consistent video recording). In addition, consent will be obtained from the resident's Legally Authorized Representative (LAR) and assent from the participant. Exclusion Criteria: * Persons living with dementia will be excluded if they: 1) are blind; 2) are deaf; 3) give indications of dissent. Variations will be sought for gender, race and ethnicity.
Contact & Investigator
Justine S Sefcik
PRINCIPAL INVESTIGATOR
Drexel University
Frequently Asked Questions
Who can join the NCT06568107 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06568107 currently recruiting?
Yes, NCT06568107 is actively recruiting participants. Contact the research team at jss398@drexel.edu for enrollment information.
Where is the NCT06568107 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06568107 clinical trial?
NCT06568107 is sponsored by Drexel University. The principal investigator is Justine S Sefcik at Drexel University. The trial plans to enroll 32 participants.