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Lighting Intervention for Parkinson’s Disease

N/A

Recruiting

Led By Rachel Saunders-Pullman

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Diagnosis of Parkinson's disease

* Difficulties with sleep or cognition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is recruiting 50 people with Parkinson's to wear an Actigraph for 7 days. 30 of them will receive a special light intervention to assess its effects on sleep, fatigue, and circadian rhythms.

Who is the study for?

This trial is for people with Parkinson's disease who have trouble sleeping or thinking clearly. They'll need to wear a sleep tracker for a week. Those with sleep issues may get special lighting in their homes to see if it helps them sleep better and feel less tired.

What is being tested?

The study tests whether a Tailored Lighting Intervention (TLI) can improve sleep, reduce fatigue, and adjust the body's internal clock in Parkinson's patients by measuring changes in melatonin levels found in urine.

What are the potential side effects?

There are no direct side effects mentioned for wearing an Actigraph or participating in the tailored lighting intervention; however, any discomforts related to these activities will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 4 for 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 4 for 7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 4 for 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sleep Duration using Actigraph

Secondary study objectives

Sleep Effeciency using Actigraph

Urine melatonin levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tailored Lighting intervention (TLI)Experimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Actigraph

2005

Completed Phase 1

~1520

0 / 2Eligibility criteria met