Clinical Trials Directory

Trials / Completed

CompletedNCT05771558

The Effect of a Lighting Intervention on Sleep in Parkinson Disease

Non-motor Features of Parkinson's Disease

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
Icahn School of Medicine at Mount Sinai · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 8 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.

Conditions

Interventions

TypeNameDescription
DEVICETailored Lighting Intervention (TLI)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.
DEVICEActigraphAn actigraph is a wrist worn devices that measures rest and activity.

Timeline

Start date
2022-11-14
Primary completion
2025-06-30
Completion
2025-06-30
First posted
2023-03-16
Last updated
2025-07-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05771558. Inclusion in this directory is not an endorsement.