Back to resultsLighting Intervention to Improve Sleep
Primary Purpose
Parkinson Disease, Sleep Disturbance
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Lighting Intervention (LIT)
Actigraph
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria: Diagnosis of Parkinson's disease and Difficulties with sleep or cognition Exclusion Criteria: There is no exclusion criteria
Sites / Locations
- Mount Sinai Beth IsraelRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tailored Lighting intervention (TLI)
Arm Description
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
Outcomes
Primary Outcome Measures
Sleep Duration using Actigraph
Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.
Sleep Duration using Actigraph
Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.
Secondary Outcome Measures
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.
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.
Urine melatonin levels
Melatonin levels will be assess from overnight urine collection
Urine melatonin levels
Melatonin levels will be assess from overnight urine collection
Full Information
NCT ID
NCT05757414
First Posted
February 21, 2023
Last Updated
March 3, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT05757414
Brief Title
Lighting Intervention to Improve Sleep
Official Title
Dissecting Oligogenic Biomarkers in Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Sleep Disturbance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tailored Lighting intervention (TLI)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Tailored Lighting Intervention (LIT)
Intervention Description
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
Intervention Name(s)
Actigraph
Intervention Description
An actigraph is a wrist worn device that measures rest and activity patterns
Primary Outcome Measure Information:
Title
Sleep Duration using Actigraph
Description
Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.
Time Frame
at baseline for 7 days
Title
Sleep Duration using Actigraph
Description
Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.
Time Frame
at Week 4 for 7 days
Secondary Outcome Measure Information:
Title
Sleep Effeciency using Actigraph
Description
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.
Time Frame
at Baseline for 7 days
Title
Sleep Effeciency using Actigraph
Description
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.
Time Frame
at Week 4 for 7 days
Title
Urine melatonin levels
Description
Melatonin levels will be assess from overnight urine collection
Time Frame
at Baseline
Title
Urine melatonin levels
Description
Melatonin levels will be assess from overnight urine collection
Time Frame
at Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Parkinson's disease and
Difficulties with sleep or cognition
Exclusion Criteria:
There is no exclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya Rawal
Phone
212-844-8373
Email
maya.rawal@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Saunders-Pullman
Organizational Affiliation
Mount Sinai Beth Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Beth Israel
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Rawal, MS, CGC
Phone
212-844-8373
Email
maya.rawal@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Maggie Markgraf, BS
Phone
212-887-3706
Email
maggie.markgraf@mountsinai.org
First Name & Middle Initial & Last Name & Degree
Rachel Saunders-Pullman
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate results will be published and shared upon request.
Learn more about this trial
Lighting Intervention to Improve Sleep
We'll reach out to this number within 24 hrs