Osteopathic Manipulative Treatment for Parkinson's (NCT06671600)

Can osteopathic treatment improve sleep

Trial ID
NCT06671600
Official Title
Effects of Osteopathic Manipulative Treatment Protocol on Sleep Quality in Parkinson's Disease Subjects
Goal
Can osteopathic treatment improve sleep
Phase
NA
Status
RECRUITING
Sponsor
New York Institute of Technology
Study Type
INTERVENTIONAL
Enrollment
32 participants
Conditions
Parkinsons Disease, Sleep
Interventions
Osteopathic Manipulative Treatment, Sham (No Treatment)
Registry Record Last Updated
2026-06-29 (1 month ago)
Estimated Commitment
Lower commitment estimated from the protocol (based on: placebo or control group). This reflects time and procedures only — confirm details with the study coordinator.

Summary For Families

Goal: to find out whether hands-on osteopathic manipulative treatment can improve sleep quality, and whether better sleep helps thinking and day-to-day activities in people with Parkinson's who have sleep problems. Approach: practitioners will use targeted hands-on techniques on the head, neck, upper back, and ribs to encourage circulation and relaxation, and outcomes will be compared to a light touch control using sleep surveys, Fitbit sleep data, and a thinking test called the Stroop task. Eligibility: people diagnosed with Parkinson's by a neurologist with mild to moderate disease (stage 0 to 3 on the common Parkinson's scale), able to lie on their back and stomach and wear a Fitbit and oxygen ring, and not taking sleep-affecting medications or having other sleep or neurological disorders.

Locations

  • New York Institute of Technology - College of Ostopathic Medicine - Academic Health Care Center - Osteopathic Medicine Center, Old Westbury, New York, United States

Making Contact: How to Call This Study Site

Who to ask for

Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.

What to say

It is fine to read this out loud, word for word:

Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT06671600. It is the one about "Can osteopathic treatment improve sleep". Could I speak with the study coordinator about taking part?

If you are calling for a family member, use their name and mention that you help with their care.

What they will ask you

  • The year of diagnosis
  • Current medications and their doses
  • Other health conditions
  • Any procedures already done, such as deep brain stimulation (DBS)
  • How far you are able to travel for study visits
  • Whether a care partner can come to visits with you

What to have ready

  • A written list of current medications and doses
  • Your neurologist's name and phone number
  • The diagnosis date. The year is enough.
  • A recent visit summary from the neurologist, if you have one

What to ask them

  • How many visits are there, and how long does each visit take?
  • Is travel, parking, or my time reimbursed?
  • Is there a placebo group, and what is my chance of being in it? The listing already answers this: This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Whether you are placed in the sham group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the sham group would be.
  • Would I need to stop or pause any of my current medications?
  • What happens when the study ends? Could I stay on the treatment if it helps?

What to expect

  • Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
  • Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
  • Asking questions commits you to nothing. You can stop the process at any point.

Frequently Asked Questions

What is this trial testing?
This trial is studying Osteopathic Manipulative Treatment. Goal: to find out whether hands-on osteopathic manipulative treatment can improve sleep quality, and whether better sleep helps thinking and day-to-day activities in people with Parkinson's who have sleep problems. Approach: practitioners will use targeted hands-on techniques on the head, neck, upper back, and ribs to encourage circulation and relaxation, and outcomes will be compared to a light touch control using sleep surveys, Fitbit sleep data, and a thinking test called the Stroop task. Eligibility: people diagnosed with Parkinson's by a neurologist with mild to moderate disease (stage 0 to 3 on the common Parkinson's scale), able to lie on their back and stomach and wear a Fitbit and oxygen ring, and not taking sleep-affecting medications or having other sleep or neurological disorders.
Who can participate?
Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; 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 2 years and 5 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 trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Whether you are placed in the sham group is decided at random. The registry does not tell us how many people go into each group, so ask the coordinator what your chance of being in the sham group would be.
What procedures are involved in this trial?
Based on the protocol, this trial involves: Questionnaires & surveys (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.

Related Reading

View on ClinicalTrials.gov