Parkinsons DiseaseNCT06671600
Effects of Osteopathic Manipulative Treatment Protocol on Sleep Quality in Parkinson's Disease Subjects
A study testing Osteopathic Manipulative Treatment in people with Parkinsons Disease and Sleep, run by New York Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinsons Disease, Sleep
- What is being tested?
- Osteopathic Manipulative Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York Institute of Technology - College of Ostopathic Medicine - Academic Health Care Center - Osteopathic Medicine Center
Old Westbury, New York, 11568
Sheldon C Yao, DO, 516-686-3799, sheldon.yao@nyit.edu
AHCC front desk, 516-686-1300
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Parkinsons Disease, Sleep
- Being tested
- Osteopathic Manipulative Treatment, Sham (No Treatment)
- Keywords
- OMM, Sleep, Parkinsons Disease, Osteopathy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentProcedure or surgery
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
- suboccipital decompression/release
- base spread
- occipitoatlantal (OA) decompression
- venous sinus drainage
- compression of the fourth ventricle
- cervical myofascial (unilateral perpendicular stretch)
- thoracic inlet release (direct or indirect)
- Bilateral rib raising
- thoracoabdominal diaphragm doming (direct technique)
- pedal pump (Dalrymple lymphatic pump)
Sham (No Treatment)Procedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
Heart rate will be measured with a Fitbit watch
Measured: 5 weeks
Sleep quality
sleep quality will be measured using a Fitbit device
Measured: 5 weeks
Sleep duration
Sleep duration will be measured using a Fitbit device
Measured: 5 weeks
Oxygen saturation
Oxygen saturation will be measured using a Fitbit device
Measured: 5 weeks
Sleep stage
Time in each sleep stage will be recorded using FitBit
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinsons DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly divided into either the treatment group who will receive OMT and the sham group who will receive light touch.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671600
- Sponsor's protocol ID
- NYIT IRB-2025-158
- Status last verified
- Jun 2026
- First submitted
- 1 Nov 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34526407
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Osteopathic Manipulative Treatment Protocol on Sleep Quality in Parkinson's Disease Subjects
- ClinicalTrials.gov ID
- NCT06671600
- Acronym / sponsor ID
- NYIT IRB-2025-158
- Conditions
- Parkinsons Disease, Sleep
- Keywords
- OMM, Sleep, Parkinsons Disease, Osteopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into either the treatment group who will receive OMT and the sham group who will receive light touch.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group (OMT) | Experimental | Procedure: Osteopathic Manipulative TreatmentFor 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- light touch | Sham comparator | Procedure: 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TreatmentOsteopathic 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) | Procedure or surgery | Treatment Group (OMT) |
| 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. | Procedure or surgery | Sham- light touch |
Primary outcome
Heart Rate Variability
Time frame: 5 weeks
Heart rate will be measured with a Fitbit watch
Sleep quality
Time frame: 5 weeks
sleep quality will be measured using a Fitbit device
Sleep duration
Time frame: 5 weeks
Sleep duration will be measured using a Fitbit device
Oxygen saturation
Time frame: 5 weeks
Oxygen saturation will be measured using a Fitbit device
Sleep stage
Time frame: 5 weeks
Time in each sleep stage will be recorded using FitBit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Results publication: PubMed 34526407Hablitz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in people with Parkinsons Disease and Sleep, run by New York Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheldon Yao, Doctor of Osteopathic Medicine (516-686-3799, sheldon.yao@nyit.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: 5 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06671600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.