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OpenTrials
Completed

NCT Number: NCT05771558

The Effect of a Lighting Intervention on Sleep in Parkinson Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parasomnias Parkinsonian Disorders Sleep Disturbance Sleep Wake Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Beth Israel

New York, 10003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Parkinson's disease and difficulties with sleep and/or cognition

Exclusion criteria

  • There are no exclusion criteria

Treatment and study plan

Tailored Lighting Intervention (TLI)

Device

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.

Actigraph

Device

An actigraph is a wrist worn devices that measures rest and activity.

Primary outcomes

  1. Sleep duration using Actigraph

    Time frame: at Baseline for 7 days

    Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.

  2. Sleep duration using Actigraph

    Time frame: at Week 8 for 7 days

    Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.

Secondary outcomes

  1. Sleep efficiency using Actigraph

    Time frame: at Baseline for 7 days

    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 would indicate an improvement.

  2. Sleep efficiency using Actigraph

    Time frame: at Week 8 for 7 days

    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 would indicate an improvement.

  3. Urine melatonin levels

    Time frame: at Baseline

    Melatonin levels will be assessed from overnight urine collection

  4. Urine melatonin levels

    Time frame: at Week 8

    Melatonin levels will be assessed from overnight urine collection

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Non-motor Features of Parkinson's Disease

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2023
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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