Bright light box for Parkinson's (NCT06129942)
Improve sleep with bright light
- Trial ID
- NCT06129942
- Official Title
- Light Therapy in Parkinson's Disease: a Prospective, Observational Study
- Goal
- Improve sleep with bright light
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Second Affiliated Hospital of Soochow University
- Study Type
- INTERVENTIONAL
- Enrollment
- 50 participants
- Conditions
- Parkinson Disease, Sleep Disorder, Circadian Rhythm Disorders
- Interventions
- Bright light box, Dim Light box
Summary For Families
The trial is testing whether daily light therapy can improve sleep and circadian rhythm problems in people with moderate Parkinson's, with the goal of improving nighttime sleep, daytime alertness, and overall function. Participants use either a bright light box or a dim light box as a control, with light exposure stimulating the retina to reset the brain's circadian clock and boost wakefulness; it does not directly change how levodopa works, and everyone keeps their Parkinson's medications stable during the study. They are looking for people aged 50 to 80 with Parkinson's at Hoehn and Yahr stages 2 to 3 who have had stable Parkinson's meds for at least one month and agree not to change them. People with major visual problems, significant cognitive impairment (MMSE under 24), uncontrolled psychiatric symptoms, current use of hypnotics or stimulants, or major circadian disruptions like shift work or recent jet lag are excluded; antidepressants are allowed only if the dose has been stable for more than three months.
Locations
- Department of Neurology, Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Bright light box. The trial is testing whether daily light therapy can improve sleep and circadian rhythm problems in people with moderate Parkinson's, with the goal of improving nighttime sleep, daytime alertness, and overall function. Participants use either a bright light box or a dim light box as a control, with light exposure stimulating the retina to reset the brain's circadian clock and boost wakefulness; it does not directly change how levodopa works, and everyone keeps their Parkinson's medications stable during the study. They are looking for people aged 50 to 80 with Parkinson's at Hoehn and Yahr stages 2 to 3 who have had stable Parkinson's meds for at least one month and agree not to change them. People with major visual problems, significant cognitive impairment (MMSE under 24), uncontrolled psychiatric symptoms, current use of hypnotics or stimulants, or major circadian disruptions like shift work or recent jet lag are excluded; antidepressants are allowed only if the dose has been stable for more than three months.
- Who can participate?
- Participants must be between 50 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 4 years and 8 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. It also includes a placebo or sham phase, so you would be on that during another period. Ask the coordinator for the exact sequence and how long each phase lasts.