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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored Lighting intervention (TLI) | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored Lighting Intervention (LIT) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Duration using Actigraph | Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement. | at baseline for 7 days |
| Sleep Duration using Actigraph | Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement. | at Week 4 for 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Effeciency using Actigraph | 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 indicates better sleep. | at Baseline for 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Saunders-Pullman | Mount Sinai Beth Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Beth Israel | New York | New York | 10003 | United States |
Aggregate results will be published and shared upon request.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 18, 2025 | Jul 11, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Actigraph | Device | An actigraph is a wrist worn device that measures rest and activity patterns |
|
| Sleep Effeciency using Actigraph | 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 indicates better sleep. | at Week 4 for 7 days |
| Urine melatonin levels | Melatonin levels will be assess from overnight urine collection | at Baseline |
| Urine melatonin levels | Melatonin levels will be assess from overnight urine collection | at Week 4 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |