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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Sleep surveys and data from Fitbit devices will be used to compare the effects of the two treatments."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether osteopathic manipulative treatment (OMT), a hands-on body treatment, can improve sleep, thinking skills, and daily activities in people with Parkinson's disease who have sleep problems. It compares OMT with a light-touch treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Parkinson's disease diagnosed by a neurologist, a doctor who treats brain and nerve conditions.
  • Have a score of 0–3 on the Hoehn and Yahr scale, which measures how severe Parkinson's disease is.
  • Be able to receive the hands-on treatment.
  • Be able to lie on your back and stomach.
  • Be able to wear a Fitbit watch and a ring that measures blood oxygen throughout the study, including during sleep.
  • Report trouble sleeping.

Who can't join

  • Take medicines that affect sleep.
  • Have already been diagnosed with a sleep disorder.
  • Have another brain or nerve condition that affects sleep patterns, such as narcolepsy, which causes extreme daytime sleepiness.
  • Have a condition that makes the study's hands-on techniques unsafe.
  • Have a score of 4 or 5 on the Hoehn and Yahr scale, which measures how severe Parkinson's disease is.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NY