The Effect of a Lighting Intervention on Sleep in Parkinson Disease
Non-motor Features of Parkinson's Disease
1 other identifier
interventional
48
1 country
1
Brief Summary
50 participants with Parkinson's disease will be recruited to complete actigraphy studies to assess sleep disturbances. For this, participants will wear an Actigraph for seven days. Thirty of these participants with sleep disturbance will go on to receive a tailored lighting intervention (TLI) to assess the effect on sleep, fatigue, and circadian entrainment via urinary melatonin levels.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Nov 2022
Typical duration for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 14, 2022
CompletedFirst Submitted
Initial submission to the registry
February 21, 2023
CompletedFirst Posted
Study publicly available on registry
March 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJuly 16, 2025
July 1, 2025
2.6 years
February 21, 2023
July 11, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Sleep duration using Actigraph
Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.
at Baseline for 7 days
Sleep duration using Actigraph
Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.
at Week 8 for 7 days
Secondary Outcomes (4)
Sleep efficiency using Actigraph
at Baseline for 7 days
Sleep efficiency using Actigraph
at Week 8 for 7 days
Urine melatonin levels
at Baseline
Urine melatonin levels
at Week 8
Study Arms (1)
Tailored Lighting Intervention (TLI)
EXPERIMENTALThe TLI will be performed for 2 hours each day over an 8-week period During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days
Interventions
The lighting intervention will provide high circadian stimulation produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system.
An actigraph is a wrist worn devices that measures rest and activity.
Eligibility Criteria
You may qualify if:
- Diagnosis of Parkinson's disease and difficulties with sleep and/or cognition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mount Sinai Beth Israel
New York, New York, 10003, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rachel Saunders-Pullman
Mount Sinai Beth Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 21, 2023
First Posted
March 16, 2023
Study Start
November 14, 2022
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
July 16, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
Aggregate results will be published and shared upon request.