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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 4 years and 8 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.