Parkinson DiseaseNCT05771558
The Effect of a Lighting Intervention on Sleep in Parkinson Disease
A study testing Tailored Lighting Intervention (TLI) and Actigraph in people with Parkinson Disease and Sleep Disturbance, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Sleep Disturbance
- What is being tested?
- Tailored Lighting Intervention (TLI) and Actigraph
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson's disease and difficulties with sleep and/or cognition
Who cannot join
- There are no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-motor Features of Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson Disease, Sleep Disturbance
- Being tested
- Tailored Lighting Intervention (TLI), Actigraph
- Medical subject headings
- Parkinson Disease, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Lighting Intervention (TLI)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.
ActigraphDevice
An actigraph is a wrist worn devices that measures rest and activity.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Lighting Intervention (TLI) | Experimental | 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 Receives: Device: Tailored Lighting Intervention (TLI); Device: Actigraph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep duration using Actigraph
Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.
Measured: at Baseline for 7 days
Sleep duration using Actigraph
Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.
Measured: at Week 8 for 7 days
Secondary outcomes (4)
Sleep efficiency 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 would indicate an improvement.
Measured: at Baseline for 7 days
Sleep efficiency 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 would indicate an improvement.
Measured: at Week 8 for 7 days
Urine melatonin levels
Melatonin levels will be assessed from overnight urine collection
Measured: at Baseline
Urine melatonin levels
Melatonin levels will be assessed from overnight urine collection
Measured: at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start14 Nov 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Saunders-Pullman, Icahn School of Medicine at Mount Sinai
- Investigators
- Rachel Saunders-Pullman, Principal investigator, Mount Sinai Beth Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771558
- Sponsor's protocol ID
- STUDY-22-00991
- Status last verified
- Jul 2025
- First submitted
- 21 Feb 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate results will be published and shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-motor Features of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05771558
- Acronym / sponsor ID
- STUDY-22-00991
- Conditions
- Parkinson Disease, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tailored Lighting Intervention (TLI) | Experimental | Device: Tailored Lighting Intervention (TLI), Device: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Parkinson's disease and difficulties with sleep and/or cognition
Key exclusion criteria (1 listed)
- There are no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Tailored Lighting Intervention (TLI) |
| ActigraphAn actigraph is a wrist worn devices that measures rest and activity. | Device | Tailored Lighting Intervention (TLI) |
Primary outcome
Sleep duration using Actigraph
Time frame: at Baseline for 7 days
Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.
Sleep duration using Actigraph
Time frame: at Week 8 for 7 days
Sleep duration will be calculated by the Actigraph software. A longer sleep duration would indicate an improvement.
4 secondary outcomes
Sleep efficiency using Actigraph
Time frame: at Baseline for 7 days
Sleep efficiency using Actigraph
Time frame: at Week 8 for 7 days
Urine melatonin levels
Time frame: at Baseline
Urine melatonin levels
Time frame: at Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No. Aggregate results will be published and shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Saunders-Pullman principal investigator
Mount Sinai Beth Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Lighting Intervention (TLI) and Actigraph in people with Parkinson Disease and Sleep Disturbance, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep duration using Actigraph (time frame: at Baseline for 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.