The Nightlight Falls Prevention Study

NCT05973448 | Enrolling By Invitation DMC

• 2 other identifiers: 22-11621R01AG075010-01
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 1

Brief Summary

This project will test the effectiveness of a novel intervention consisting of unobtrusive, low-intensity, horizontal and vertical lights that outline the bathroom or entry way doorframe in residents' rooms and provide visual cues to promote postural stability. Specifically, this pragmatic crossover trial will enroll 335 assisted living residents with dementia and follow them for one year, comparing the incidence of nighttime falls during the lighting condition to the incidence of falls during the control condition; secondarily, it will determine whether and to what extent the intervention effect is modified by resident- and environmental-level risk factors, and satisfaction with the lighting system.

Conditions

Aging; Alzheimer Disease; Dementia Alzheimers; Dementia of Alzheimer Type; Fall Injury

Keywords

Aging; Alzheimer's Disease; Alzheimer's Disease Related Dementias; Assisted Living; Fall Injury

Outcome Measures

Primary Outcomes (1)

• Falls incidence density ratio

  (Number of falls/Number of Nights Novel) / (Number of falls/Number of Nights Control)

  At study completion (one year)

Study Arms (4)

Lighting Sequence 1: CCLL

OTHER

In this arm, the participant will receive the control lighting condition (C) for the first two quarters (180 days) and then crossover to the novel lighting condition (L) for the last two quarters (180 days). Q1 - Control lighting Q2 - Control lighting Q3 - Novel lighting Q4 - Novel lighting

Other: Novel Lighting Condition; Other: Control Lighting Condition

Lighting Sequence 2: CLLC

OTHER

In this arm, the participant will receive the control lighting condition (C) for the first quarter (90 days) and then crossover to the novel lighting condition (L) for the next two quarters (180 days) and finally crossover again to the control condition (C) for the last quarter (90 days). Q1 - Control lighting Q2 - Novel lighting Q3 - Novel lighting Q4 - Control lighting

Other: Novel Lighting Condition; Other: Control Lighting Condition

Lighting Sequence 3: LCCL

OTHER

In this arm, the participant will receive the novel lighting condition (L) for the first quarter (90 days) and then crossover to the control lighting condition (C) for the next two quarters (180 days) and finally crossover again to the novel condition (L) for the last quarter (90 days). Q1 - Novel lighting Q2 - Control lighting Q3 - Control lighting Q4 - Novel lighting

Other: Novel Lighting Condition; Other: Control Lighting Condition

Lighting Sequence 4: LLCC

OTHER

In this arm, the participant will receive the novel lighting condition (L) for the first two quarters (180 days) and then crossover to the control lighting condition (C) for the last two quarters (180 days). Q1 - Novel lighting Q2 - Novel lighting Q3 - Control lighting Q4 - Control lighting

Other: Novel Lighting Condition; Other: Control Lighting Condition

Interventions

Novel Lighting Condition OTHER

Horizontal and vertical lights over a doorway visible from the bed

Also known as: Indicated in sequence by "L"

Lighting Sequence 1: CCLL; Lighting Sequence 2: CLLC; Lighting Sequence 3: LCCL; Lighting Sequence 4: LLCC

Control Lighting Condition OTHER

Standard night light plugged into wall socket

Also known as: Indicated in sequence by "C"

Lighting Sequence 1: CCLL; Lighting Sequence 2: CLLC; Lighting Sequence 3: LCCL; Lighting Sequence 4: LLCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a diagnosis of dementia
• Lives in a participating AL community
• Not blind
• Not on hospice and in a worsening state
• Not expected to die or transfer during the next 6 months
• Reside in a private room; or reside in a shared room if
• one resident is male and one is female and both are participating in the project, or
• they are of any gender, as long as there is a wall divider between their bedrooms
• Do not have an overnight sitter in the room every night

You may not qualify if:

• None

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sheryl Zimmerman, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participating community will have approximately 8-12 enrolled residents with ADRD. The AL communities will be randomized to four treatment sequences over the course of one year that define the order of the lighting intervention delivered across four 3-month (90 day) periods (N=335 residents). This design requires that the lights be turned on or off some periods, which will be done by research staff during scheduled visits. The four treatment sequences are chosen such that each resident receives control (C) lighting in two periods and novel lighting (L) in two periods and no more than 2 lighting changes. The four sequences are: CCLL, CLLC, LCCL, LLCC. There are no "washout" periods between the lighting conditions.

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 2, 2023
• Study Start: July 28, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
• Access Criteria: An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.

Locations

US (1)