Trials / Completed
CompletedNCT05771558
The Effect of a Lighting Intervention on Sleep in Parkinson Disease
Non-motor Features of Parkinson's Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Icahn School of Medicine at Mount Sinai · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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 | Actigraph | An actigraph is a wrist worn devices that measures rest and activity. |
Timeline
- Start date
- 2022-11-14
- Primary completion
- 2025-06-30
- Completion
- 2025-06-30
- First posted
- 2023-03-16
- Last updated
- 2025-07-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05771558. Inclusion in this directory is not an endorsement.