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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 week 4 for 7 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sleep Duration using Actigraph

Secondary outcome measures

Sleep Effeciency using Actigraph

Urine melatonin levels

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

N/A

~1440

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

860 Previous Clinical Trials

524,426 Total Patients Enrolled

Rachel Saunders-PullmanPrincipal InvestigatorMount Sinai Beth Israel

1 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Tailored Lighting Intervention (LIT) Clinical Trial Eligibility Overview. Trial Name: NCT05757414 — N/A

Parkinson's Disease Research Study Groups: Tailored Lighting intervention (TLI)

Parkinson's Disease Clinical Trial 2023: Tailored Lighting Intervention (LIT) Highlights & Side Effects. Trial Name: NCT05757414 — N/A

Tailored Lighting Intervention (LIT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05757414 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are actively engaged in this research endeavor?

"Affirmative. Clinicaltrials.gov records verify that this research, which was originally published on November 16th 2021, is actively in search of volunteers. Approximately 50 trial participants must be recruited from 1 site."

Answered by AI

Is the enrollment process for this experiment still open?

"Indeed, according to information available on clinicaltrials.gov, this study is currently enlisting patients for participation. The trial was first initiated on November 16th 2021 and most recently updated on March 3rd 2023. A total of 50 participants are required from a single medical site."

Answered by AI