Parkinson Disease (PD)NCT07299240
Remote Ischemic Conditioning for Sleep Disturbances and Other Non-motor Symptoms in Parkinson's Disease
A study testing Remote ischemic conditioning device in people with Parkinson Disease (PD) and Insomnia, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
Trial summary
This single-center, randomized, single-blind, sham-controlled clinical trial aims to evaluate whether remote ischemic conditioning (RIC) can improve sleep disturbances and other non-motor symptoms in patients with Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Parkinson Disease (PD), Insomnia
- What is being tested?
- Remote ischemic conditioning device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2026
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Brain Hospital of Nanjing Medical University, 264 Guangzhou Road
Nanjing, Jiangsu, 210029
Haochen Sun, MD, +86-025-82296261, 735690822@qq.com
About this study
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
This single-center, randomized, single-blind, sham-controlled clinical trial aims to evaluate whether remote ischemic conditioning (RIC) can improve sleep disturbances and other non-motor symptoms in patients with Parkinson's disease (PD). Forty-eight PD patients with insomnia will be randomly assigned in a 1:1 ratio to receive either active RIC (cuff inflation to high pressure) or sham RIC (cuff inflation to low pressure) for 7 consecutive days, in addition to their standard antiparkinsonian medications. Subjective sleep scales, sleep diaries, validated rating scales for motor and non-motor symptoms, and overnight polysomnography will be used to assess treatment effects at baseline, after the 7-day intervention, and during short-term follow-up. The study will also explore potential mechanisms of RIC by combining EEG, functional MRI, retinal optical coherence tomography, and blood biomarkers.
Read the detailed description
Parkinson's disease (PD) is a common neurodegenerative disorder characterized not only by motor symptoms, but also by a wide spectrum of non-motor symptoms. Sleep disturbances, including insomnia and fragmented sleep, are highly prevalent in PD and markedly impair quality of life, yet current pharmacological therapies have limited efficacy and may cause adverse effects. Remote ischemic conditioning (RIC) is a non-invasive intervention induced by repeated brief episodes of limb ischemia and reperfusion using an inflatable cuff. Experimental and clinical studies suggest that RIC can modulate immune responses, humoral mediators, neural activity and circadian rhythms. Based on these observations, we hypothesize that RIC may improve sleep disturbances and other non-motor symptoms in PD.
In this study, 48 PD patients with insomnia will be recruited from the outpatient clinics and inpatient wards of Nanjing Brain Hospital. Eligible participants will be randomized (1:1) to an active RIC group or a sham RIC group on top of stable antiparkinsonian medications. 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. The primary objective is to determine whether RIC improves subjective and objective sleep parameters in PD patients with insomnia. Secondary objectives include assessing changes in other non-motor symptoms, motor symptoms, cognition, mood, autonomic function, quality of life and exploratory imaging and blood biomarkers.
- Conditions
- Parkinson Disease (PD), Insomnia
- Being tested
- Remote ischemic conditioning device, Sham remote ischemic conditioning
- Keywords
- remote ischemic conditioning, Parkinson's disease, insomnia, non-motor symptoms
- Medical subject headings
- Parkinson Disease, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioning deviceDevice
Also called RIC training device
An automated upper-limb cuff device is applied to one arm to induce brief episodes of limb ischemia and reperfusion. In the active RIC group, the cuff is inflated to a high pressure (approximately 200 mmHg) sufficient to occlude arterial blood flow, and then deflated repeatedly according to a pre-set program recommended by the manufacturer. RIC is performed twice daily for 7 consecutive days.
Sham remote ischemic conditioningDevice
The same device and procedure are used as in the active RIC group, but the cuff is inflated only to a low pressure (approximately 60 mmHg) that does not occlude arterial blood flow. Sham RIC is performed twice daily for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Active RIC group | Experimental | Participants receive active remote ischemic conditioning plus standard antiparkinsonian medications. Receives: Device: Remote ischemic conditioning device |
| Sham RIC group | Sham comparator | Participants receive sham remote ischemic conditioning (low-pressure cuff inflation) plus standard antiparkinsonian medications. Receives: Device: Sham remote ischemic conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) total score
The PDSS-2 is a 15-item patient-reported questionnaire assessing sleep problems in Parkinson's disease. Total scores range from 0 to 60, with higher scores indicating more severe sleep disturbances. The primary outcome is the change in PDSS-2 total score from baseline to the end of the 7-day RIC or sham RIC intervention.
Measured: From baseline to 7 days after the start of RIC
Secondary outcomes (2)
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score (0-260 points; higher scores indicate worse motor and non-motor symptoms).
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is used to assess motor and non-motor symptoms in Parkinson's disease. The total score ranges from 0 to 260 points, with higher scores indicating more severe impairment. The outcome measure is the change in MDS-UPDRS total score from baseline to 7 days after remote ischemic conditioning (RIC).
Measured: Baseline to 7 days after RIC
Change in Montreal Cognitive Assessment (MoCA) total score (0-30 points; higher scores indicate better cognitive function).
The Montreal Cognitive Assessment (MoCA) is a 30-point screening instrument for global cognitive function. Total scores range from 0 to 30 points, with higher scores indicating better cognition. The outcome measure is the change in MoCA total score from baseline to 7 days after remote ischemic conditioning (RIC).
Measured: Baseline to 7 days after RIC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease (PD)Studies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haochen Sun, Principal investigator, Department of Neurology, the Affiliated Brain Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299240
- Sponsor's protocol ID
- 2024-KY088-02
- Status last verified
- Jul 2026
- First submitted
- 10 Dec 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the main published results will be made available to qualified researchers upon reasonable request and after approval by the principal investigator and the Institutional Review Board.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07299240
- Acronym / sponsor ID
- 2024-KY088-02
- Conditions
- Parkinson Disease (PD), Insomnia
- Keywords
- remote ischemic conditioning, Parkinson's disease, insomnia, non-motor symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Jiangsu Province Nanjing Brain HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Dec 2025 (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.
This single-center, randomized, single-blind, sham-controlled clinical trial aims to evaluate whether remote ischemic conditioning (RIC) can improve sleep disturbances and other non-motor symptoms in patients with Parkinson's disease (PD). Forty-eight PD patients with insomnia will be randomly assigned in a 1:1 ratio to receive either active RIC (cuff inflation to high pressure) or sham RIC (cuff inflation to low pressure) for 7 consecutive days, in addition to their standard antiparkinsonian medications. Subjective sleep scales, sleep diaries, validated rating scales for motor and non-motor symptoms, and overnight polysomnography will be used to assess treatment effects at baseline, after the 7-day intervention, and during short-term follow-up. The study will also explore potential mechanisms of RIC by combining EEG, functional MRI, retinal optical coherence tomography, and blood biomarkers.
Detailed description
Parkinson's disease (PD) is a common neurodegenerative disorder characterized not only by motor symptoms, but also by a wide spectrum of non-motor symptoms. Sleep disturbances, including insomnia and fragmented sleep, are highly prevalent in PD and markedly impair quality of life, yet current pharmacological therapies have limited efficacy and may cause adverse effects. Remote ischemic conditioning (RIC) is a non-invasive intervention induced by repeated brief episodes of limb ischemia and reperfusion using an inflatable cuff. Experimental and clinical studies suggest that RIC can modulate immune responses, humoral mediators, neural activity and circadian rhythms. Based on these observations, we hypothesize that RIC may improve sleep disturbances and other non-motor symptoms in PD.
In this study, 48 PD patients with insomnia will be recruited from the outpatient clinics and inpatient wards of Nanjing Brain Hospital. Eligible participants will be randomized (1:1) to an active RIC group or a sham RIC group on top of stable antiparkinsonian medications. 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. The primary objective is to determine whether RIC improves subjective and objective sleep parameters in PD patients with insomnia. Secondary objectives include assessing changes in other non-motor symptoms, motor symptoms, cognition, mood, autonomic function, quality of life and exploratory imaging and blood biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active RIC group | Experimental | Device: Remote ischemic conditioning deviceParticipants receive active remote ischemic conditioning plus standard antiparkinsonian medications. |
| Sham RIC group | Sham comparator | Device: Sham remote ischemic conditioningParticipants receive sham remote ischemic conditioning (low-pressure cuff inflation) plus standard antiparkinsonian medications. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Remote ischemic conditioning deviceAlso: RIC training deviceAn automated upper-limb cuff device is applied to one arm to induce brief episodes of limb ischemia and reperfusion. In the active RIC group, the cuff is inflated to a high pressure (approximately 200 mmHg) sufficient to occlude arterial blood flow, and then deflated repeatedly according to a pre-set program recommended by the manufacturer. RIC is performed twice daily for 7 consecutive days. | Device | Active RIC group |
| Sham remote ischemic conditioningThe same device and procedure are used as in the active RIC group, but the cuff is inflated only to a low pressure (approximately 60 mmHg) that does not occlude arterial blood flow. Sham RIC is performed twice daily for 7 consecutive days. | Device | Sham RIC group |
Primary outcome
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) total score
Time frame: From baseline to 7 days after the start of RIC
The PDSS-2 is a 15-item patient-reported questionnaire assessing sleep problems in Parkinson's disease. Total scores range from 0 to 60, with higher scores indicating more severe sleep disturbances. The primary outcome is the change in PDSS-2 total score from baseline to the end of the 7-day RIC or sham RIC intervention.
2 secondary outcomes
Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score (0-260 points; higher scores indicate worse motor and non-motor symptoms).
Time frame: Baseline to 7 days after RIC
Change in Montreal Cognitive Assessment (MoCA) total score (0-30 points; higher scores indicate better cognitive function).
Time frame: Baseline to 7 days after RIC
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 28 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the main published results will be made available to qualified researchers upon reasonable request and after approval by the principal investigator and the Institutional Review Board.
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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.
Haochen Sun principal investigator
Department of Neurology, the Affiliated Brain Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning device in people with Parkinson Disease (PD) and Insomnia, run by Jiangsu Province Nanjing Brain Hospital at 1 site in China.
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 7 inclusion and 8 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 28 Jul 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 China. 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 Haochen Sun, MD (+86-025-82296261, 735690822@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) total score (time frame: From baseline to 7 days after the start of RIC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.