--- title: Can arm cuff improve insomnia nct_id: NCT07299240 phase: NA status: RECRUITING sponsor: Jiangsu Province Nanjing Brain Hospital study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT07299240" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07299240" last_fetched: "2026-07-28T14:00:49.206Z" source: "Parkinson's Pathways (curated)" --- # Can arm cuff improve insomnia **Goal (in five words):** Can arm cuff improve insomnia **Official Title:** Remote Ischemic Conditioning for Sleep Disturbances and Other Non-motor Symptoms in Parkinson's Disease: a Randomized, Single-blind, Sham-controlled Clinical Study **Trial ID:** [NCT07299240](https://clinicaltrials.gov/study/NCT07299240) ## Key Facts - **Phase:** NA - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** Jiangsu Province Nanjing Brain Hospital - **Target Enrollment:** 48 participants - **Start Date:** 2026-01-01 - **Completion Date:** 2026-12-31 - **Conditions:** Parkinson Disease (PD), Insomnia - **Interventions:** Remote ischemic conditioning device, Sham remote ischemic conditioning - **Intervention Types:** DEVICE ## Summary For Families The goal is to find out whether brief arm cuff treatments that repeatedly stop and restart blood flow can improve insomnia and other non-motor problems in people with Parkinson's disease. The approach uses an inflatable cuff on the arm inflated to high pressure (active) or low pressure (sham) twice a day for 7 days, given in addition to each person’s usual Parkinson's medicines; prior work suggests this may change immune signals, circulating factors, brain activity, and the body clock. Sleep will be measured with questionnaires, sleep diaries and overnight sleep studies, and the study will also do brain electrical recordings, functional magnetic resonance imaging, eye imaging of the retina, and blood tests to explore how it might work. The study plans to enroll 48 people aged 50 to 70 who have Parkinson's for 5 years or less, are in early-to-moderate stages, have diagnosable insomnia, and are on a stable medication plan. ## What This Actually Involves **Placebo** _(From the protocol)_: This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio. **Visits** _(From the protocol)_: You will have two nights of polysomnography before treatment, receive RIC or sham RIC twice daily for 7 consecutive days, have repeat assessments after the 7-day intervention, and a further clinical and neurophysiological assessment approximately 21 days after RIC ends. > "Each participant will undergo two nights of polysomnography (one adaptation night and one baseline recording), comprehensive clinical assessments, EEG, retinal optical coherence tomography (OCT) and functional MRI (fMRI) before the intervention. RIC or sham RIC will then be performed twice daily for 7 consecutive days. After completion of the 7-day intervention, polysomnography, EEG, fMRI, OCT, clinical rating scales and blood sampling will be repeated. A further clinical and neurophysiological assessment will be conducted approximately 21 days after the end of RIC to evaluate the persistence of treatment effects." **Procedures** _(From the protocol)_: - MRI scan (Non-invasive) > "The study will also explore potential mechanisms of RIC by combining EEG, functional MRI, retinal optical coherence tomography, and blood biomarkers." - Brain wave recording (EEG) (Non-invasive) > "The study will also explore potential mechanisms of RIC by combining EEG, functional MRI, retinal optical coherence tomography, and blood biomarkers." **Washout** _(Ask the coordinator)_: Ask the coordinator whether you would need to stop or pause any of your current medications before or during the study (a washout period), and for how long. **Travel & reimbursement** _(Ask the coordinator)_: Ask the coordinator whether travel, parking, or your time is reimbursed or compensated, and what is covered. _Fields marked “From the protocol” come from the trial's registry record or quoted protocol text. Fields marked “Ask the coordinator” are not reliably available and should be confirmed directly._ ## Eligibility at a Glance Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call. - **Disease stage:** Hoehn and Yahr stage 1 to 3 - **Medication dose:** Must be on a stable dose of Parkinson's medication (criteria text: "* on a stable regimen of antiparkinsonian medications for at least 4 weeks prior to enrollment, with no expected dose changes during the study period") - **Time since diagnosis:** Diagnosed within the last 5 years (criteria text: "* disease duration <= 5 years") ## Eligibility - **Minimum age:** 50 Years - **Maximum age:** 70 Years - **Sex:** ALL ### Full Criteria ``` 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. ``` ## Locations (1) - The Affiliated Brain Hospital of Nanjing Medical University, 264 Guangzhou Road, Nanjing, Jiangsu, China _(32.0617, 118.7778)_ - Haochen Sun, MD, (CONTACT), +86-025-82296261, 735690822@qq.com ## Central Contacts - Haochen Sun, MD, (CONTACT), +86-025-82296261, 735690822@qq.com ## Making Contact: How to Call This Study Site ### Who to ask for Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study. ### What to say It is fine to read this out loud, word for word: > Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07299240. It is the one about "Can arm cuff improve insomnia". Could I speak with the study coordinator about taking part? If you are calling for a family member, use their name and mention that you help with their care. ### What they will ask you - The year of diagnosis - Current medications and their doses - Other health conditions - Any procedures already done, such as deep brain stimulation (DBS) - How far you are able to travel for study visits - Whether a care partner can come to visits with you ### What to have ready - A written list of current medications and doses - Your neurologist's name and phone number - The diagnosis date. The year is enough. - A recent visit summary from the neurologist, if you have one ### What to ask them - How many visits are there, and how long does each visit take? The listing already answers this: You will have two nights of polysomnography before treatment, receive RIC or sham RIC twice daily for 7 consecutive days, have repeat assessments after the 7-day intervention, and a further clinical and neurophysiological assessment approximately 21 days after RIC ends. Ask the coordinator to confirm it still applies. - Is travel, parking, or my time reimbursed? - Is there a placebo group, and what is my chance of being in it? The listing already answers this: This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio. - Would I need to stop or pause any of my current medications? - What happens when the study ends? Could I stay on the treatment if it helps? ### What to expect - Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal. - Many callers do not end up joining. Screening out is common and is not a judgment about you or your health. - Asking questions commits you to nothing. You can stop the process at any point. --- *Canonical: https://parkinsonspathways.com/trial/NCT07299240* *HTML version: https://parkinsonspathways.com/trial/NCT07299240* *Source data: https://clinicaltrials.gov/study/NCT07299240*