Health TrialsbyHealthPanel

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

ConditionsParkinsons DiseaseSleep
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNew York Institute of Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Osteopathic Manipulative Treatment

    Procedure/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 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/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.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Treatment Group (OMT)Experimental treatment 1 intervention
Group B: Sham- light touchSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Heart Rate Variability

Heart rate will be measured with a Fitbit watch

Time frame
5 weeks
2

Sleep quality

sleep quality will be measured using a Fitbit device

Time frame
5 weeks
3

Sleep duration

Sleep duration will be measured using a Fitbit device

Time frame
5 weeks
4

Oxygen saturation

Oxygen saturation will be measured using a Fitbit device

Time frame
5 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

New York Institute of Technology

Lead sponsor

Source ClinicalTrials.gov
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