An interventional study of Osteopathic Manipulative Treatment and Sham (No Treatment) in Parkinsons Disease and Sleep, sponsored by New York Institute of Technology. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by New York Institute of Technology · Not applicable, Interventional, and Treatment
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.
Parkinsonism is primarily linked to Parkinsons disease (PD) and presents a range of symptoms including tremors at rest, muscle stiffness, slowed movement (bradykinesia), and difficulties with balance. These symptoms can significantly disrupt sleep patterns, making it challenging for individuals to both fall asleep and stay asleep. As a result, many patients experience reduced sleep quality, which can adversely affect their overall well-being and make them more vulnerable to additional health problems, including cognitive decline.
Osteopathic manipulative treatment (OMT) is a holistic, hands-on therapy aimed at enhancing the body's natural ability to heal and function. It focuses on manipulating the body's muscles and joints to improve circulation and promote relaxation, which may lead to better sleep outcomes. Unlike some conventional treatments that often come with unwanted side effects, OMT offers a potentially safer, individualized approach to managing sleep disorders, especially in the context of Parkinsons disease.
Despite the promising indications that OMT could improve sleep quality, there has been a lack of focused research on its application specifically for patients with Parkinsons disease. This study aims to fill that gap by investigating how targeted OMT can influence sleep quality, cognitive function, and daily activities in individuals diagnosed with PD.
The treatment protocol will specifically target areas of the body such as the cranial, cervical, thoracic, and rib regions, using established OMT techniques that have previously shown efficacy in enhancing sleep quality. Participants will be assigned to one of two groups: the treatment group receiving OMT and a control group receiving a light touch treatment, which serves as a placebo.
To assess the effectiveness of the OMT, the investigators will employ a variety of measurement tools. Sleep quality will be evaluated through self-reported surveys as well as objective data collected using Fitbit devices, which can track sleep patterns and quality metrics. Additionally, cognitive function, particularly executive function, will be assessed through the Stroop task, a well-established cognitive test that measures a persons ability to manage conflicting information.
By systematically comparing the outcomes of the OMT group to those of the control group, this research aims to demonstrate the potential benefits of OMT as a complementary treatment for improving sleep quality in patients with Parkinsons disease. The findings could pave the way for integrating OMT into standard care practices, ultimately enhancing the quality of life for individuals living with this challenging condition.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 32 is below the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →New York Institute of Technology is the lead sponsor of 59 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For the Osteopathic Manipulative Medicine(OMM) treatment group, an osteopathic manipulative treatment protocol will be applied to the cranial, cervical, thoracic, and ribcage regions. OMM procedures performed on the treatment group will consist of 1. suboccipital decompression/release 2. base spread 3. occipitoatlantal (OA) decompression 4. venous sinus drainage 5. compression of the fourth ventricle 6. cervical myofascial (unilateralperpendicular stretch) 7. thoracic inlet release (direct or indirect) 8. Bilateral rib raising 9. thoracoabdominal diaphragm doming (direct technique) 10. pedal pump (Dalrymple lymphatic pump). All aforementioned techniques are based on the protocol from Foundations of Osteopathic Medicine.
Procedure: Osteopathic Manipulative Treatment
The sham group will serve as the control group and will receive a light touch-control procedure based on prior study utilizing light touch
Procedure: Sham (No Treatment)
Osteopathic manipulative treatment(OMT) protocol will be applied to the cranial, cervical, thoracic, and ribcage regions. OMT procedures performed on the treatment group will consist of 1. suboccipital decompression/release 2. base spread 3. occipitoatlantal (OA) decompression 4. venous sinus drainage 5. compression of the fourth ventricle 6. cervical myofascial (unilateral perpendicular stretch) 7. thoracic inlet release (direct or indirect) 8. Bilateral rib raising 9. thoracoabdominal diaphragm doming (direct technique) 10. pedal pump (Dalrymple lymphatic pump)
The sham group will serve as the control group and will receive a light touch-control procedure based on prior study utilizing light touch.
Heart Rate Variability
Heart rate will be measured with a Fitbit watch
Time frame: 5 weeks
Sleep quality
sleep quality will be measured using a Fitbit device
Time frame: 5 weeks
Sleep duration
Sleep duration will be measured using a Fitbit device
Time frame: 5 weeks
Oxygen saturation
Oxygen saturation will be measured using a Fitbit device
Time frame: 5 weeks
Sleep stage
Time in each sleep stage will be recorded using FitBit
Time frame: 5 weeks
Plan to share: No
Started Aug 2025 (actual). Primary completion is estimated for Dec 2027, 28 months after the start.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 28 months is above that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
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New York Institute of Technology