The Effect of a Lighting Intervention on Sleep in Parkinson Disease

NCT ID: NCT05771558

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-14

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson Disease Sleep Disturbance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Tailored Lighting Intervention (TLI)

Intervention Type 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

Intervention Type DEVICE

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

Interventions

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Tailored Lighting Intervention (TLI)

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.

Intervention Type DEVICE

Actigraph

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Parkinson's disease and difficulties with sleep and/or cognition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Rachel Saunders-Pullman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Saunders-Pullman

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Beth Israel

Locations

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Mount Sinai Beth Israel

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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STUDY-22-00991

Identifier Type: -

Identifier Source: org_study_id

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