NCT06671600 Effects of Osteopathic Manipulative Treatment Protocol on Sleep Quality in Parkinson's Disease Subjects
| NCT ID | NCT06671600 |
| Status | Recruiting |
| Phase | — |
| Sponsor | New York Institute of Technology |
| Condition | Parkinsons Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2025-08-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Parkinsonism, mainly caused by Parkinsons disease (PD), includes symptoms like tremors, stiffness, slow movements, and balance problems. These symptoms can make it hard for people to sleep well, which leads to a lower quality of life and can increase the risk of other health issues and cognitive decline. Osteopathic manipulative treatment (OMT) is a hands-on approach that may help improve sleep without the side effects of traditional treatments. While OMT has shown promise in enhancing sleep, no studies have specifically looked at its effects on sleep in Parkinson's disease patients. This study aims to see if OMT can help improve sleep quality, cognitive function, and daily activities for people with PD. The investigators will focus on treating specific areas of the body, using techniques that have helped improve sleep in the past. Participants will be divided into two groups: one will receive OMT, while the other will get a light touch treatment as a control. Sleep surveys and data from Fitbit devices will be used to compare the effects of the two treatments. Additionally, cognitive function will be assessed using a specific task called the Stroop task. This research could show that OMT can be a valuable addition to treatments for improving sleep quality in people with Parkinsons disease.
Eligibility Criteria
Inclusion Criteria: * Must have a diagnosis of Parkinson's disease as per a neurologist * Severity of 0-3 on the Hoehn and Yahr (H-Y) Scale * Able to receive OMM * Able to be in a supine and prone position. * Able to wear a Fitbit watch and an oxygen saturation ring for the duration of the study (including when sleeping). * Have sleep disturbance complaints. Exclusion Criteria: * Patients on medications that affect sleep * Have a pre-existing sleep disorder diagnosis * Those who have a concurrent neurological diagnosis that would confound sleep patterns (ie. narcolepsy) * Contraindications to the OMM techniques used in this protocol * Severity of 4 and 5 on the Hoehn and Yahr Scale
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06671600 clinical trial?
This trial is open to participants of all sexes, studying Parkinsons Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06671600 currently recruiting?
Yes, NCT06671600 is actively recruiting participants. Contact the research team at sheldon.yao@nyit.edu for enrollment information.
Where is the NCT06671600 trial being conducted?
This trial is being conducted at Old Westbury, United States.
Who is sponsoring the NCT06671600 clinical trial?
NCT06671600 is sponsored by New York Institute of Technology. The trial plans to enroll 32 participants.
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