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NCT05825404 · ClinicalTrials.gov registry record · NA

Smart Lighting for Nursing Home Residents With Dementia

A NA study of Alzheimer's Disease and Related Dementias, sponsored by Penn State University.

Completed
Registry status
NA
Development phase
51
Enrollment target
2
Study locations

NCT05825404: Completed NA study of Alzheimer's Disease and Related Dementias, sponsored by Penn State University.

NCT05825404 is a NA study of Alzheimer's Disease and Related Dementias that has completed, run by Penn State University. The registered enrollment target is 51 participants, below the 1,629-participant average among 5 other Alzheimer's Disease and Related Dementias trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05825404, a NA study of Alzheimer's Disease and Related Dementias, has completed, sponsored by Penn State University.

COMPLETED
Registry status
NA
Development phase
51 participants
Enrollment target
2
Study locations

Study Summary

This proposed study seeks to develop a smart ambient bright light (SABL) intervention to provide auto-controlled, consistent indoor lighting that incorporates natural daylight. This SABL includes tunable LED lights, photosensors, and controllers. The SABL system has a pre-programmed 24-hour control schedule for illuminance settings to mimic the natural bright-dark cycle. It will automatically adjust the lights to accommodate the daylight effect to minimize staff burden and maximize the LI effect. The SABL will be installed in participants' bedrooms and designated areas in the dining rooms and activity rooms for four weeks. Each participant will wear a personal light monitor to measure the lighting dosage each participant receives. This study will address three aims: 1) pilot test the effect of SABL on reducing agitation in persons with ADRD, 2) evaluate the fidelity of the SABL delivery, and 3) evaluate the feasibility of implementing the SABL. The study will be conducted in two NHs in Pennsylvania. For aims 1 and 2, the investigators will use a crossover, cluster randomized control trial (RCT) and will enroll residents with ADRD and agitation. For aim 3, the investigators will use a mixed methods design and will interview NH stakeholders to evaluate the acceptability, feasibility, and appropriateness of the intervention. This is the first study that incorporates daylight in ambient light interventions and the first study that addresses the measurement, feasibility, and fidelity of lighting interventions. Findings will establish evidence-based implementation strategies and the best design for SABL to reduce agitation for persons with ADRD in NHs.

Primary Outcome

Average Lux during Intervention and Control Periods at the facility level This is a cluster crossover RCT design. Two nursing homes were randomly assigned to two different sequences; one nursing home began with the intervention light (weeks 2-5), followed by the control condition (8-11), while the other nursing home began with the control condition (weeks 2-5), followed by the intervention light (week 8-11). Data were collected in weeks 1, 3, 5, 7, 9, 11, and 13. Results were combined and categ

Interventions

  • OTHER Control
  • DEVICE Smart Ambient Bright Light (SABL)

Study Locations (2)

Pennsylvania

  • Valley View Retirement Community - Belleville
  • Christ the King Manor - DuBois

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2023-04-24
Est. Completion 2023-12-05
Phase NA
Penn State University

219 total trials

What the finished NCT05825404 record still lists

NCT05825404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,629-participant average among 5 other Alzheimer's Disease and Related Dementias trials with a reported enrollment target (97% lower).

The record links to 1 condition, with Alzheimer's Disease and Related Dementias appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.

NCT05825404 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT05825404 about?

NCT05825404 is a clinical study titled "Smart Lighting for Nursing Home Residents With Dementia". This proposed study seeks to develop a smart ambient bright light (SABL) intervention to provide auto-controlled, consistent indoor lighting that incorporates natural daylight. This SABL includes tunable LED lights, photosensors, and controllers. The SABL system has a pre-programmed 24-hour control ...

What is the current status of trial NCT05825404?

This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2023-04-24. Estimated completion is 2023-12-05.

What conditions does trial NCT05825404 study?

This clinical trial studies the following conditions: Alzheimer's Disease and Related Dementias.

What interventions are being tested in trial NCT05825404?

The interventions under investigation include: Control (OTHER), Smart Ambient Bright Light (SABL) (DEVICE).

Who is sponsoring clinical trial NCT05825404?

This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05825404 being conducted?

This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05825404, the US trial registry maintained by the National Library of Medicine. NCT05825404 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.