Recruiting

OMT

Sponsor:

New York Institute of Technology

Code:

NCT06671600

Conditions

Parkinsons Disease

Sleep

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Osteopathic Manipulative Treatment

Sham (No Treatment)

Study Details

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.

Conditions

Parkinsons Disease

Sleep

Study ID

NCT06671600

Start date

Aug 1, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Osteopathic Manipulative 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)

Sham (No 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.

Primary outcome measure

  • Heart Rate Variability [ Time Frame: 5 weeks ]
  • Sleep quality [ Time Frame: 5 weeks ]
  • Sleep duration [ Time Frame: 5 weeks ]
  • Oxygen saturation [ Time Frame: 5 weeks ]
  • Sleep stage [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Sheldon Yao, Doctor of Osteopathic Medicine

516-686-3799sheldon.yao@nyit.edu

Locations

New York Institute of Technology - College of Ostopathic Medicine - Academic Health Care Center - Osteopathic Medicine Center

Recruiting

Old Westbury, New York, United States, 11568

Contacts

Sheldon C Yao, DO

516-686-3799sheldon.yao@nyit.edu

AHCC front desk

516-686-1300

More Information

Sponsor

New York Institute of Technology

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • OMM
  • Sleep
  • Parkinsons Disease
  • Osteopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York Institute of Technology on 2026-06-29.