Determine how balance affects sleep
- Trial ID
- NCT07424924
- Official Title
- The Relationship Between Balance and Gait Impairments, Physical Activity Level, and Sleep Quality in Parkinson's Disease
- Goal
- Determine how balance affects sleep
- Status
- RECRUITING
- Sponsor
- Biruni University
- Study Type
- OBSERVATIONAL
- Enrollment
- 34 participants
- Conditions
- Parkinson Disease
Summary For Families
The team wants to understand how balance and walking problems in Parkinson's relate to daily physical activity and sleep quality, because those connections can influence falls, fatigue, and overall function. Participants with Parkinson's and matched healthy volunteers will have balance and gait tested and their activity and sleep tracked using clinical assessments and smartphone-based monitoring to find patterns between mobility, activity level, and sleep. No treatment is given; Parkinson's participants should be Hoehn and Yahr stages 1 to 3, able to walk independently, on a stable medication plan, and tested while in their "on" phase. The study is looking for adults 40 to 75 years old who use a smartphone and do not have major other neurological, cardiovascular, orthopedic, hearing, or vision problems.
Locations
- Biruni University Hospital, Istanbul, Turkey (Türkiye)
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The team wants to understand how balance and walking problems in Parkinson's relate to daily physical activity and sleep quality, because those connections can influence falls, fatigue, and overall function. Participants with Parkinson's and matched healthy volunteers will have balance and gait tested and their activity and sleep tracked using clinical assessments and smartphone-based monitoring to find patterns between mobility, activity level, and sleep. No treatment is given; Parkinson's participants should be Hoehn and Yahr stages 1 to 3, able to walk independently, on a stable medication plan, and tested while in their "on" phase. The study is looking for adults 40 to 75 years old who use a smartphone and do not have major other neurological, cardiovascular, orthopedic, hearing, or vision problems.
- Who can participate?
- Participants must be between 40 Years and 75 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 2 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.