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Lighting Intervention to Improve Sleep

Dissecting Oligogenic Biomarkers in Parkinson Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05757414
Enrollment
57
Registered
2023-03-07
Start date
2021-11-16
Completion date
2025-06-30
Last updated
2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease, Sleep Disturbance

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.

Interventions

DEVICETailored 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.

DEVICEActigraph

An actigraph is a wrist worn device that measures rest and activity patterns

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* There is no

Design outcomes

Primary

MeasureTime frameDescription
Sleep Duration using Actigraphat baseline for 7 daysSleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.

Secondary

MeasureTime frameDescription
Sleep Effeciency using Actigraphat Baseline for 7 daysSleep 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.
Urine melatonin levelsat BaselineMelatonin levels will be assess from overnight urine collection

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026