Arm cuff therapy shows promise for Parkinson's sleep troubles

NCT ID NCT07299240

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Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

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First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study tests a non-invasive treatment called remote ischemic conditioning (RIC) for sleep problems in people with Parkinson's disease. For 7 days, 48 participants will receive either active RIC (using a blood pressure cuff to briefly restrict arm blood flow) or a sham version. Researchers will measure changes in sleep quality, movement, and other symptoms using questionnaires and overnight sleep tests.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of Parkinson's disease according to the Movement Disorder Society (MDS) clinical diagnostic criteria. * Age between 50 and 70 years. * Disease duration ≤ 5 years. * Hoehn and Yahr stage I-III in the "on" state. * Presence of insomnia that meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria and clinically significant sleep complaints (for example, Parkinson's Disease Sleep Scale-2 \[PDSS-2\] total score ≥ 18 points). * On a stable regimen of antiparkinsonian medications for at least 4 weeks prior to enrollment, with no expected dose changes during the study period. * Able to understand the study procedures and provide written informed consent (or consent provided by a legally authorized representative when appropriate). Exclusion Criteria: * Secondary insomnia due to other severe medical conditions (e.g., uncontrolled cardiopulmonary, hepatic, renal, or endocrine diseases). * Current psychotic symptoms or severe anxiety or depression (e.g., Hamilton Anxiety Scale score ≥ 14 or Hamilton Depression Scale score ≥ 17). * Other primary sleep disorders such as moderate-to-severe obstructive sleep apnea, restless legs syndrome, periodic limb movement disorder, or rapid eye movement sleep behavior disorder that require specific treatment. * History of significant cerebrovascular disease, brain tumor, central nervous system infection, or other neurological disorders that may interfere with sleep or study assessments. * Contraindications to remote ischemic conditioning (RIC), including severe peripheral arterial disease of the upper limbs, local soft tissue infection or damage at the cuff site, subclavian artery thrombosis, malignant hypertension, severe cardiac disease, active bleeding disorders, or other conditions judged unsafe by the investigator. * Contraindications to MRI or EEG examinations (e.g., pacemaker, severe claustrophobia, metallic implants incompatible with MRI). * Participation in another interventional clinical trial within the past 3 months. * Inability to comply with the study procedures or follow-up visits, as judged by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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Contacts and locations

Locations

  • The Affiliated Brain Hospital of Nanjing Medical University, 264 Guangzhou Road

    RECRUITING

    Nanjing, Jiangsu, 210029, China

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