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The Effect of a Lighting Intervention on Sleep in Parkinson Disease

Not Applicable
Recruiting
Conditions
Parkinson Disease
Sleep Disturbance
Interventions
Device: Tailored Lighting Intervention (TLI)
Device: Actigraph
Registration Number
NCT05771558
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 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
50
Inclusion Criteria
  • Diagnosis of Parkinson's disease and difficulties with sleep and/or cognition
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Exclusion Criteria
  • There are no exclusion criteria
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Tailored Lighting Intervention (TLI)ActigraphThe TLI will be performed for 2 hours each day over an 8-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)Tailored Lighting Intervention (TLI)The TLI will be performed for 2 hours each day over an 8-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
NameTimeMethod
Sleep duration using Actigraphat Week 8 for 7 days

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

Secondary Outcome Measures
NameTimeMethod
Sleep efficiency using Actigraphat 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.

Urine melatonin levelsat Week 8

Melatonin levels will be assessed from overnight urine collection

Trial Locations

Locations (1)

Mount Sinai Beth Israel

🇺🇸

New York, New York, United States

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