Lighting Intervention to Improve Sleep

Not Applicable

Recruiting

• Conditions: Sleep Disturbance; Parkinson Disease
• Interventions: Device: Tailored Lighting Intervention (LIT); Device: Actigraph

• Registration Number: NCT05757414
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study Start: 2021-11-16
• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-07
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-04
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

• There is no exclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tailored Lighting intervention (TLI)	Tailored Lighting Intervention (LIT)	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
Tailored Lighting intervention (TLI)	Actigraph	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

Primary Outcome Measures

Name	Time	Method
Sleep Duration using Actigraph	at Week 4 for 7 days	Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.

Secondary Outcome Measures

Name	Time	Method
Sleep Effeciency using Actigraph	at Week 4 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 indicates better sleep.
Urine melatonin levels	at Week 4	Melatonin levels will be assess from overnight urine collection

Trial Locations

Locations (1)

Mount Sinai Beth Israel; 🇺🇸 New York, New York, United States