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

NCT06671600 | Not Yet Recruiting

• 1 other identifier: NYIT IRB-2025-158
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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

Keywords

OMM; Sleep; Parkinsons Disease; Osteopathy

Outcome Measures

Primary Outcomes (5)

• Heart Rate Variability

  Heart rate will be measured with a Fitbit watch

  5 weeks

• Sleep quality

  sleep quality will be measured using a Fitbit device

  5 weeks

• Sleep duration

  Sleep duration will be measured using a Fitbit device

  5 weeks

• Oxygen saturation

  Oxygen saturation will be measured using a Fitbit device

  5 weeks

• Sleep stage

  Time in each sleep stage will be recorded using FitBit

  5 weeks

Study Arms (2)

Treatment Group (OMT)

EXPERIMENTAL

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

Sham- light touch

SHAM COMPARATOR

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)

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)

Treatment Group (OMT)

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.

Sham- light touch

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• New York Institute of Technology: lead

Related Publications (1)

• Hablitz LM, Nedergaard M. The Glymphatic System: A Novel Component of Fundamental Neurobiology. J Neurosci. 2021 Sep 15;41(37):7698-7711. doi: 10.1523/JNEUROSCI.0619-21.2021.

  PMID: 34526407 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Manipulation, Osteopathic; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Sheldon Yao, Doctor of Osteopathic Medicine

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly divided into either the treatment group who will receive OMT and the sham group who will receive light touch.

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: April 8, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share