Lighting Intervention to Improve Sleep

Study Overview
=================
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.

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.

Official Title
-----------------
Dissecting Oligogenic Biomarkers in Parkinson Disease

Conditions
-----------------
Parkinson Disease, Sleep Disturbance

Intervention / Treatment
-----------------
* Device: Tailored Lighting Intervention (LIT)
* Device: Actigraph


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Parkinson's disease and Difficulties with sleep or cognition Exclusion Criteria: There is no exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored Lighting intervention (TLI)<br>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)<br>* 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.<br>Device: Actigraph<br>* An actigraph is a wrist worn device that measures rest and activity patterns<br>|

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 |