Lighting Intervention to Improve Sleep

Parkinson Disease Clinical Trial

Official title:

Dissecting Oligogenic Biomarkers in Parkinson Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757414
• Other study ID #: STUDY-19-00185
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Maya Rawal
• Phone: 212-844-8373
• Email: maya.rawal[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Parkinson's disease and

• Difficulties with sleep or cognition

Exclusion Criteria:

• There is no exclusion criteria

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Parkinson Disease
• Sleep Disturbance

Intervention

Device:
• Tailored 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.
• Actigraph
An actigraph is a wrist worn device that measures rest and activity patterns

Locations

Country	Name	City	State
United States	Mount Sinai Beth Israel	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	Urine melatonin levels	Melatonin levels will be assess from overnight urine collection	at Baseline
Secondary	Urine melatonin levels	Melatonin levels will be assess from overnight urine collection	at Week 4