Lighting Intervention to Improve Sleep

Dissecting Oligogenic Biomarkers in Parkinson Disease

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Sleep Disturbance
• Intervention / Treatment: Device: Tailored Lighting Intervention (LIT); Device: Actigraph

Detailed Description

Participants will undergo one week of baseline data collection using the actigraph and light meter and one night of an overnight urine collection. At the completion of the baseline week, the lighting intervention will be installed in the participants home. Participants will be exposed to the lighting intervention for 2 hours each morning after awakening for 4 weeks. During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days and collect one overnight urine sample. Participants will complete questionnaires before and after the intervention to further assess its effects.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Mount Sinai Beth Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Parkinson's disease and
• Difficulties with sleep or cognition

Exclusion Criteria:

• There is no exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tailored Lighting intervention (TLI); The TLI will be performed for 2 hours each day over a 4-week period. During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days	Device: Tailored Lighting Intervention (LIT); 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.; Device: Actigraph; An actigraph is a wrist worn device that measures rest and activity patterns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 4 for 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Effeciency using Actigraph	Sleep efficiency will be calculated by the Actigraph software. Sleep efficiency refers to the percentage of time a person sleeps, in relation to the amount of time a spent in bed. The percentage is calculated by dividing actual sleep time by time in bed. A higher sleep efficiency indicates better sleep.	at Baseline for 7 days
Sleep Effeciency using Actigraph	Sleep efficiency will be calculated by the Actigraph software. Sleep efficiency refers to the percentage of time a person sleeps, in relation to the amount of time a spent in bed. The percentage is calculated by dividing actual sleep time by time in bed. A higher sleep efficiency indicates better sleep.	at Week 4 for 7 days
Urine melatonin levels	Melatonin levels will be assess from overnight urine collection	at Baseline
Urine melatonin levels	Melatonin levels will be assess from overnight urine collection	at Week 4

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Rachel Saunders-Pullman, Mount Sinai Beth Israel

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): July 16, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: STUDY-19-00185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregate results will be published and shared upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No