Effects of Osteopathic Manipulative Treatment Protocol on Sleep Quality in Parkinson's Disease Subjects

Part of paid clinical trials in Old Westbury, New York.

Sponsor
New York Institute of Technology
Study ID
NCT06671600
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osteopathic Manipulative Treatment — PROCEDURE
    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)
  • Sham (No Treatment) — PROCEDURE
    The sham group will serve as the control group and will receive a light touch-control procedure based on prior study utilizing light touch.

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Group (OMT)
    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.
  • Sham Comparator: Sham- light touch
    The sham group will serve as the control group and will receive a light touch-control procedure based on prior study utilizing light touch

Primary Outcome Measure

Heart Rate Variability [ Time Frame: 5 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York Institute of Technology - College of Ostopathic Medicine - Academic Health Care Center - Osteopathic Medicine CenterOld WestburyNew York11568
Sheldon C Yao, DO
[email protected]
516-686-3799
AHCC front desk
516-686-1300

Find similar trials in Old Westbury, NY

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
New York Institute of Technology - College of Ostopathic Medicine - Academic Health Care Center - Osteopathic Medicine Center· Old Westbury, NY

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